Allen 1998
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment, 3 months and 1 year.
Participants	End of treatment n = 27, 3-month follow-up = 27, 12-month follow-up = 21 Start of treatment n = 27 Sex of children: 11 M, 16 F Sex of parents: not reported Mean age of children = 12.2 Mean age of parents = not reported Source = referred by paediatricians and neurologists in the community and recruited by newspaper ad Diagnosis of child = migraine headache Mean years of illness = 4.4 years
Interventions	“Thermal Biofeedback plus Parent Pain Behaviour Management” (CBT) “Thermal Biofeedback” Mode of delivery: individual, face to face Intervention delivered by: authors Training: not reported Duration of intervention (child, hrs) = 6 × 40 minutes = 4 hours Duration of intervention (parent, hours) = not reported
Outcomes	* Extracted measures Child measures Pain diary* Coping Assistance Questionnaire Child Perception Abbreviated Acceptability Rating Profile Parent measures Parent Perception of Pain Interference Questionnaire* Coping Assistance Questionnaire for Parents* Abbreviated Acceptability Rating Profile
Yates Quality Scale	Study quality (out of 35): 14 (low quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 9 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Randomized, controlled group-outcome design, subjects were assigned to either thermal biofeedback intervention.…., or the same biofeedback ntervention plus pain behavior management guidelines”. Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	High risk	Data were incompletely reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Ambrosino 2008
Methods	RCT. 2 arms. Assessed pre-treatment, 1 month (end of treatment), 3 months, 6 months and 12 months post intervention.
Participants	End of treatment n = 81 children, 3-month follow-up = 79 children, 6-month follow-up = 72, 12-month follow-up = 72 Start of treatment n = 87 parents and children received intervention at start Sex of children: 34 M, 53 F Sex of parents: 5 M, 82 F Mean age of children = 9.91 (+/-1.44) Mean age of parents = 40.01 (+/- 5.40) Source = Yale Pediatric Diabetes Program Diagnosis of child = type 1 diabetes Mean years of illness = 3.71 +/- 2.91 years
Interventions	“Coping Skills Training (CST)” (CBT) “Group Education (GE)” Mode of delivery: groups, face to face, parents met separately Intervention delivered by: mental health professionals Training: not reported Duration of intervention (child, hours) = 6 × 1.5 = 9 hours Duration of intervention (parent, hours) = 6 × 1.5 = 9 hours
Outcomes	* Extracted measures Child measures Metabolic control* Child Depression Inventory (CDI)* Disease-related variables Issues in Coping with IDDM - Child scale Self-Efficacy for Diabetes Scale Diabetes Quality of Life Scale for Youth (DQOL) Diabetes Family Behavior Scale (DFBS) Parent measures Center for Epidemiologic Depression Scale (CES-D)* Family Adaptability and Cohesion Scale (FACES II)* Issues in Coping with IDDM - Parent scale Diabetes Responsibility and Conflict Scale
Yates Quality Scale	Study quality (out of 35): 29 (high quality) Treatment quality (out of 9): 7 (high quality) Design quality (out of 26): 22 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Participants were randomised initially by a sealed envelope technique and later by computer to either the coping skills therapy of group eduction.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Participants were randomised initially by a sealed envelope technique and later by computer to either the coping skills therapy of group eduction.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Unclear risk	“All follow-up data were collected by trained research assistants.” Comment: blinding unclear, probably not done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were fully reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Askins 2009
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment and at 3 months.
Participants	End of treatment n = 131 mothers, 3-month follow-up = 123 mothers Start of treatment n = 197 mothers Sex of children: 103 M, 94 F Sex of parents: 0M, 197 F Mean age of child = 8.1 Mean age of parents = 36.3 Source = 4 paediatric cancer centres in USA Diagnosis of child = cancer Mean years of illness = average 6 weeks since diagnosis, range 2 to 16 weeks from diagnosis
Interventions	“Problem-Solving Skills Training” (PST) “Problem-Solving Skills Training + Personal Digital Assistant” Mode of delivery: individual, face to face Intervention delivered by: therapists with graduate training in Clinical Psychology Training: special training in PSST Duration of intervention (child, hours) = 0 Duration of intervention (parent, hours) = 8 × 1 =8 hours
Outcomes	* Extracted measures Parent measures Social Problem-Solving Inventory-Revised (SPSI-R)* Beck Depression Inventory-ll (BDI-II)* Profile of Mood States (POMS) Impact of Event Scale-Revised (IES-R)
Yates Quality Scale	Study quality (out of 35): 27 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 18 (high quality)
Notes	The comparison looks like a non inferiority trial but it was not designed in this way so we have included it despite the lack of a control group
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Computerized randomisation to one of the three treatment arms was performed at the data management centre.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Computerized randomisation to one of the three treatment arms was performed at the data management centre.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Unclear risk	Data were fully reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Barakat 2010
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 12 months.
Participants	End of treatment n = 37, 12-month follow-up = 34 Start of treatment n = 42 received session 1 Sex of children: 15 M, 12 F Sex of parents: not reported Mean age of child = 14.17 (1.75) Mean age of parents = not reported Source =“Comprehensive sickle cell centre” Diagnosis of child = sickle cell disease Mean years of illness = lifetime
Interventions	“Pain Management Intervention” (CBT) “Disease Education Intervention” Mode of delivery: individual families, face to face Intervention delivered by: Clinical Psychology doctoral students Training: not reported Duration of intervention (child, hours) = 4 × 90 minutes = 6 hours Duration of intervention (parent, hours) = 4 × 90 minutes = 6 hours
Outcomes	* Extracted measures Child measures Pain diary (% days with pain and % interference with activities)* Coping Strategies Questionnaire Family Cohesion Scale* Health-related Hindrance Inventory Health Service Use per Medical Chart Review School Attendance Records
Yates Quality Scale	Study quality (out of 35): 27 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 18 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“A 2-group, randomised treatment design was used.” Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were fully reported. Aims, measures and results only partially concordant. Comment: probably some reporting bias.
Barry 1997
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 3 months.
Participants	End of treatment n = 29, 3-month follow-up = 29 Start of treatment n = 36 Sex of children: 10 M, 19 F Sex of parents: not reported Mean age of child = 9.4 Mean age of parents = not reported Source = ads in elementary schools and community health centres, referrals from paediatricians and family physicians Diagnosis of child = headache Mean years of illness = 2 headaches/month
Interventions	“Cognitive Behavioural Therapy” (CBT) “Wait-list Control” Mode of delivery: group, face to face Intervention delivered by: mental health professionals Training: not reported Duration of intervention (child, hours) = 2 × 90 minutes = 3 hours Duration of intervention (parent, hours) = 2 × 90 minutes = 3 hours
Outcomes	* Extracted measures Child measures Pain diary*
Yates Quality Scale	Study quality (out of 35): 16 (low quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 11 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Each parent-child pair was initially matched with another pair based on the child's age, sex and headache pain as indicated by the parents' ratings of average duration, frequency, and intensity of headaches. Subsequently, one of each of the matched parent-child pairs was randomly assigned to either the treatment condition or the waiting list control condition.” Comment: method not described.
Allocation concealment (selection bias)	High risk	“Each parent-child pair was initially matched with another pair based on the child's age, sex and headache pain as indicated by the parents' ratings of average duration, frequency, and intensity of headaches.”
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	High risk	Data were not fully reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Celano 2012
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 6 months.
Participants	End of treatment n = 40, 6-month follow-up = 37 Start of treatment n = 43 Sex of children: 26 M, 15 F Sex of parents: 85% female Mean age of child = 10.5(1.6) Mean age of parents = not reported Source = urban children's hospital and residential camp for children with asthma Diagnosis of child = asthma Mean years of illness = more than 1 year
Interventions	“Home based family intervention” “Enhanced treatment as usual” Mode of delivery: individual families, face to face Intervention delivered by: trained asthma counsellors, post-doctoral psychology fellow and respiratory therapist Training: not reported Duration of intervention (child, hours) = 4 to 6 sessions, average 78 minutes per session Duration of intervention (parent, hours) = 4 to 6 sessions, average 78 minutes per session
Outcomes	* Extracted measures Child measures Family Asthma Management System Scale Metered Dose Inhaler Checklist Cotinine/creatinine ratio Number of school days missed Asthma symptom days* Urgent health care visits Medical records reviewed Parent measures Family Asthma Management System Scale Parenting Stress Index (PSI-SF) Brief Symptoms Inventory (for parent distress)*
Yates Quality Scale	Study quality (out of 35): 19 (high quality) Treatment quality (out of 9): 6 (high quality) Design quality (out of 26): 13 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomisation….by blocked randomisation within age group (8 to 10 vs. 11 to 13).” Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Low risk	“Trained assistants blind to group assignment.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Connelly 2006
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 2 months.
Participants	End of treatment n = 31, 2-month follow-up = 31 Start of treatment n = 37 Sex of children: 19 M, 18 F Sex of parents: not reported Mean age of child = 9.2 (1.7) Mean age of parents = not reported Source = outpatient neurology clinic at a large children's hospital in Midwestern USA Diagnosis of child = headache Mean years of illness = 2 years 3 months (2 years 2 months)
Interventions	“Headstrong CD ROM” (CBT) “Wait-list Control” Mode of delivery: computer and phone calls Intervention delivered by: CD ROM Training: not reported Duration of intervention (child, hours) = 4 × 1 hr = 4 hours Duration of intervention (parent, hours) = 1 × 1 hr = 1 hours
Outcomes	* Extracted measures Child measures Headache diary* Pediatric Migraine Disability Assessment* Parent measures Headache diary Pediatric Migraine Disability Assessment
Yates Quality Scale	Study quality (out of 35): 25 (high quality) Treatment quality (out of 9): 7 (high quality) Design quality (out of 26): 18 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomly assigned to one of two groups by a research assistant using a uniform random numbers table.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Randomly assigned to one of two groups by a research assistant using a uniform random numbers table.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“Study neurologists remained blind to randomisation condition throughout the study. Chance of unblinding were limited because follow-up appointments with the study neurologist were scheduled for 2 months following the initial assessment.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Duarte 2006
Methods	RCT. 2 arms. Assessed at first, second, third and fourth session (sessions were monthly).
Participants	End of treatment n = 32 children Start of treatment n = 32 children Sex of children: 10 M,22 F Sex of parents: not reported Mean age of children = 9.15 (2.1) Mean age of parents = not reported Source = Pediatric Gastroenterology Reference Service Diagnosis of child = recurrent abdominal pain Mean years of illness = 25 +/- 17.5 months
Interventions	“Cognitive-behavioural family intervention” (CBT) “Control group” Mode of delivery: face to face (group/individual not reported) Intervention delivered by: general health professionals Training: not reported Duration of intervention (child, hours) = 4 × 50 minutes = 3 hours, 20 minutes Duration of intervention (parent, hours) = 4 × 50 minutes = 3 hours, 20 minutes
Outcomes	* Extracted measures Child measures Pain diary* Visual analogue scale Pressure Pain Threshold
Yates Quality Scale	Study quality (out of 35): 7 (low quality) Treatment quality (out of 9): 4 (low quality) Design quality (out of 26): 3 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Randomly allocated to 2 groups.” Comment: probably done but unclear method
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	Unclear risk	Data were incompletely reported. Aims, measures and results were fully concordant. Comment: probably some reporting bias.
Ellis 2004
Methods	RCT. 2 arms. Assessed pre-treatment, 6 months after study entry (end of treatment).
Participants	End of treatment = 25 Start of treatment n = 31 Sex of children: 14 M, 11 F Sex of parents: all female Mean age of children = 13.6 (1.6) Mean age of parents = 0 M, 31 F Source = endocrinology clinic within a tertiary care children's hospital Diagnosis = type 1 diabetes Mean years of illness = at least 1 year
Interventions	“Multisystemic Therapy” (MST) “Standard Care Control” Mode of delivery: individual families, face to face and phone contact Intervention delivered by: mental health professionals Training:Completed 1 week MST training Duration of intervention (child) = mean 6.5 months, 46 sessions Duration of intervention (parent) = mean 6.5 months, 46 sessions
Outcomes	* Extracted measures Child measures Metabolic control* Twenty-Four Hour Recall Interview Frequency of blood glucose testing from blood glucose meter The Diabetes Management Scale (DMS) Health Service Use per Medical Chart Review Parent measures Satisfaction with treatment The Diabetes Management Scale (DMS)
Yates Quality Scale	Study quality (out of 35): 26 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 17 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Randomisation to treatment or control group was completed immediately after baseline data collection by the project statistician.” Comment: no description provided.
Allocation concealment (selection bias)	Low risk	“Randomisation to treatment or control group was completed immediately after baseline data collection by the project statistician.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“All data was collected by a trained research assistant who was blind to the adolescent's treatment status.” Comment: probably done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were fully reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Ellis 2005
Methods	RCT. 2 arms. Assessed pre-treatment, 7 months after study entry (end of treatment), 12 months after study entry (6-month follow-up).
Participants	End of treatment n = 110, 6-month follow-up = 85 Start of treatment n = 127 children and their families Sex of children: 62 M, 65 F Sex of parents: not reported Mean age of children = 13.25 (+/-1.95) Mean age of parents = 38.8 (+/-6.8) Source = endocrinology clinic within a tertiary care children's hospital Diagnosis = type 1 diabetes Mean years of illness = 5.25 (+/- 4.35) years
Interventions	“Multisystemic Therapy” (MST) “Standard Care Control” Mode of delivery: individual families, face to face and phone contact Intervention delivered by: mental health professional Training: 1-week training in MST and diabetes education Duration of intervention (child) = mean 5.7 months, 48 sessions Duration of intervention (parent) = mean 5.7 months, 48 sessions
Outcomes	* Extracted measures Child measures HbA1c Levels* Diabetes Stress Questionnaire* Family Relationship Index (FRI) of the Family Environment Scale (FES)* Frequency of Blood Glucose Testing from blood glucose meter Twenty-Four Hour Recall Interview Health Service Use per Medical Chart Review (hospitalisations, emergency department visits) Diabetes Family Behavior Checklist (DFBC) Diabetes Family Responsibility Questionnaire Parental overestimation of adolescent responsibility score Parent measures Family Relationship Index (FRI) of the Family Environment Scale (FES)* Diabetes Family Behavior Checklist (DFBC) Diabetes Family Responsibility Questionnaire
Yates Quality Scale	Study quality (out of 35): 23 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 15 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Random assignment to treatment group was completed after baseline data collection.” Comment: no method described.
Allocation concealment (selection bias)	Unclear risk	“To ensure equivalence across treatment conditions, random assignment was stratified according to HbA1c level at the baseline visit.”
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were incompletely reported. Aims, measures and results fully concordant. Comment: probably some reporting bias.
Grey 2011
Methods	RCT. 2 arms. Assessed pre-treatment, 3 months, 6 months and 12 months post-treatment. Data came from 2 separate randomised clinical trials of coping skills training interventions: one trial included parents and their 8 to 12-year old children, and the other trial included parents of children under 8 years of age.
Participants	End of treatment n = 129, 3 months = 121, 6 months = 120, 12 months = 112 Start of treatment n = 129 Sex of children: 53 M, 74 F Sex of parents: not reported Mean age of children = 8.0 (2.8) Mean age of parents = not reported Source = paediatric diabetes clinic at a university-based medical centre Diagnosis = type 1 diabetes Mean years of illness = at least 6 months
Interventions	“Coping skills training group” (CBT) “Group diabetes education” Mode of delivery: group, face to face Intervention delivered by: mental health professional Training: not reported Duration of intervention (child) = not reported. Duration of intervention (parent) = 1.5 hours × 6 sessions = 9 hours (treatment), 1.5 hours × 4 sessions = 6 hours (control)
Outcomes	* Extracted measures Child measures HbA1c Levels Parent measures Issues in Coping with IDDM-Parent Scale The Center for Epidemiologic Studies-Depression Scale The Diabetes Responsibility and Conflict Scale The Parents Diabetes Quality of Life Questionnaire
Yates Quality Scale	Study quality (out of 35): 24 (high quality) Treatment quality (out of 9): 7 (high quality) Design quality (out of 26): 17 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Data from two separate randomised trials…Participants were randomised using a sealed envelope technique” Comment: combined 2 studies together to produce results.
Allocation concealment (selection bias)	Low risk	“Participants were randomised using a sealed envelope technique.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“Data were collected….by trained research assistants who were blinded to group assignment.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	High risk	Aims, measures and results were fully concordant, but data presented were combined. Comment: probably some reporting bias.
Hicks 2006
Methods	RCT. 2 arms. Assessed pre-treatment, 1-month follow-up and 3-month follow-up.
Participants	End of treatment n = 37, 1-month follow-up = 37, 3-month follow-up = 32 Start of treatment n = 47 Sex of children: 17 M, 30 F Sex of parents: not reported Mean age of children = 11.7 (2.1) Mean age of parents = not reported Source = media, posters in physicians offices and advertisements in school newsletters Diagnosis = recurrent head or abdominal pain Mean years of illness = 3 years
Interventions	“Online cognitive-behavioral treatment programme” (CBT) “Wait list Control” Mode of delivery: individual, online web programme, email and phone contact Intervention delivered by: Internet and researcher Training: not reported Duration of intervention (child) = mean 3 hours on the phone, duration to complete online programme not described Duration of intervention (parent) = not described
Outcomes	* Extracted measures Child measures Pain diary* Pediatric Quality of Life Inventory Treatment expectation Treatment satisfaction Parent measures Pediatric Quality of Life Inventory Treatment expectation Treatment satisfaction
Yates Quality Scale	Study quality (out of 35): 24 (high quality) Treatment quality (out of 9): 6 (high quality) Design quality (out of 26): 18 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The 47 participants were stratified by age and pain severity and randomly assigned by blocks to either the treatment condition or the standard medical care wait-list condition.” Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	“The 47 participants were stratified by age and pain severity and randomly assigned by blocks to either the treatment condition or the standard medical care wait-list condition.”
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were incompletely reported. Aims, measures and results fully concordant. Comment: probably some reporting bias.
Hoekstra-Weebers 1998
Methods	RCT. 2 arms. Pre-treatment (at diagnosis), post-treatment, 6-month follow-up
Participants	End of treatment and 6-month follow-up n = 81 parents, 41 children Start of treatment n = 120 parents, 61 children Sex of parents: 40 M, 41 F Sex of children: 23 M, 18 F Mean age of parents = 36.6 (5.4) Mean age of children = 6.4 (4.7) Source = paediatric oncology clinic Diagnosis = cancer Mean years of illness = 2 to 21 days post diagnosis
Interventions	“Psychoeducational and Cognitive-Behavioral Intervention” (CBT) “Standard Care Control” Mode of delivery: individual, face to face Intervention delivered by: Master's student in Psychology Training: not reported Duration of intervention (child) = 0 Duration of intervention (parent) = 8 × 90 minutes = 12 hours
Outcomes	* Extracted measures Parent measures Symptom Check List (SCL)* State-Trait Anxiety Inventory-State* Goldberg General Health Questionnaire (GHQ) Social Support List-Discrepancies (SSL-D) Intensity of emotions questionnaire designed by the authors
Yates Quality Scale	Study quality (out of 35): 20 (high quality) Treatment quality (out of 9): 6 (high quality) Design quality (out of 26): 14 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Parents were randomly assigned…. parents drew one of two envelopes in which a letter indicated in which group they were placed.” Comment: method unclear.
Allocation concealment (selection bias)	Unclear risk	“Parents were randomly assigned…. parents drew one of two envelopes in which a letter indicated in which group they were placed.” Comment: probably done but unsure whether envelopes were sealed or numbered.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results fully concordant. Comment: probably no reporting bias.
Kashikar-Zuck 2005
Methods	RCT. 2 arms. Assessed pre-treatment and post-treatment.
Participants	End of treatment n = 27 Start of treatment n = 30 Sex of children: 0 M, 30 F Sex of parents: 3 M, 27 F Mean age of children = 15.83(1.26) Mean age of parents = not reported Source = paediatric rheumatology clinic, Midwestern USA Diagnosis = fibromyalgia syndrome Mean years of illness = over 2 years
Interventions	“Cognitive Skills Training” (CBT) “Self Monitoring” Mode of delivery: individual, face to face plus phone contact Intervention delivered by: doctoral level paediatric psychology intern or psychology fellow Training: trained by principal investigator Duration of intervention (child) = 6 sessions, hours not reported Duration of intervention (parent) = 3 sessions, hours not reported
Outcomes	* Extracted measures Child measures Children's Depression Inventory* (CDI) Functional Disability Inventory* (FDI) Visual analogue scale (VAS) Pain Coping Questionnaire (PCQ) Tender point examination
Yates Quality Scale	Study quality (out of 35): 22 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 14 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“A computer generated pseudo-random number list was used. A simple randomisation technique was used with a 1:1 allocation ratio for 30 subjects as a single block.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“A computer generated pseudo-random number list was used. A simple randomisation technique was used with a 1:1 allocation ratio for 30 subjects as a single block.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“A research assistant who was blind to the study objectives and to the subjects' treatment assignment administered the self-report measures. The rheumatologist or occupational therapist who conducted the tender point assessments was blind to the subjects' treatment assignment.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Kashikar-Zuck 2012
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment, 6-month follow-up
Participants	End of treatment n = 106, follow-up n = 100 Start of treatment n = 114 Sex of children: 9 M, 105 F Sex of parents: not reported Mean age of children = 15.0 (1.8) Mean age of parents = not reported Source = 4 paediatric rheumatology centres, Midwestern USA Diagnosis = fibromyalgia syndrome Mean years of illness = 2 years, 10 months (2 years, 6 months)
Interventions	“Cognitive behavioural therapy” (CBT) “Fibromyalgia education” Mode of delivery: individual, face to face Intervention delivered by: therapists with postdoctoral training in paediatric psychology Training: 6 to 8-hour training by principal investigator Duration of intervention (child) = 6 hours Duration of intervention (parent) = 2 hours, 15 minutes
Outcomes	* Extracted measures Child measures Child Depression Inventory* (CDI) Functional Disability Inventory* (FDI) Visual analogue scale* (VAS) Pediatric Quality of Life Inventory (PedsQL)
Yates Quality Scale	Study quality (out of 35): 33 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 24 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Eligible patients were randomly assigned to 1 of the 2 treatment arms based upon a computer-generated randomisation list. Randomisation was stratified by site.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“When a patient was enrolled, the study therapist contacted the biostatistician to obtain the subject identification number and treatment allocation.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“The principle investigator, study physicians, study coordinator, and assessment staff were all blinded to the patients' treatment condition throughout the trial. Patients were asked not to divulge what treatment they were receiving to the study physician.” Comment: probably done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Kazak 2004
Methods	RCT. 2 arms. Assessed pre-treatment and 3 to 5 months post-treatment
Participants	End of treatment n = 116 children Start of treatment n = 150 children Sex of children: 73 M, 77 F Sex of parents: 106 M, 146 F Mean age of children = 14.61 (2.4) Mean age of parents = not reported Source = oncology tumour registry at the Children's Hospital of Philadelphia Diagnosis = childhood cancer survivor Mean years of illness = 5.30 (2.92) years post-treatment
Interventions	“Surviving Cancer Competently Intervention Program SCCIP” (CBT) “Wait-list Control” Mode of delivery: group, face to face Intervention delivered by: nurses, social workers, psychologists, graduate and postdoctoral psychology trainees Training: 12 hours Duration of intervention (child) = 5 hours direct, 2 hours informal Duration of intervention (parent) = 5 hours direct, 2 hours informal
Outcomes	* Extracted measures Child measures Post-Traumatic Stress Disorder Reaction Index (PTSD-RI)* Impact of Events Scale-Revised (IES-R) Revised Children's Manifest Anxiety Scale (RCMAS) Parent measures Post-Traumatic Stress Disorder Reaction Index (PTSD-RI)* Impact of Events Scale-Revised (IES-R) State-Trait Anxiety Inventory (STAI)
Yates Quality Scale	Study quality (out of 35): 24 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 15 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Families were randomised to the treatment or wail-list control condition.” Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Unclear risk	Data were incompletely reported. Aims, measures and results were fully concordant. Comment: probably some reporting bias.
Laffel 2003
Methods	RCT. 2 arms. Assessed at pre-treatment and 1 year.
Participants	End of treatment n = 100 children Start of treatment n = 105 Sex of children: 53 M.47 F Sex of parents: not reported Mean age of children = 12.1 (2.3) Mean age of parents = not reported Source = Joslin Diabetes Center Pediatric and Adolescent Unit Diagnosis = type 1 diabetes Mean years of illness = 2.7 years +/-1.6 years
Interventions	“Teamwork Intervention” (FT) “Standard Care” Mode of delivery: individual families, face to face Intervention delivered by: research assistant Training: not reported Duration of intervention (child) = 4 sessions over 1 year (hours not reported) Duration of intervention (parent) = 4 sessions over 1 year (hours not reported)
Outcomes	* Extracted measures Child measures Glycemic Control (A1c)* Diabetes Family Conflict Scale* Clinician Report of Adherence to Diabetes Management Tasks Diabetes Family Responsibility Questionnaire Joint structured interview to assess parental involvement in diabetes management tasks Pediatric Quality of Life Inventory (PedsQL) Parent measures Diabetes Family Conflict Scale* Diabetes Family Responsibility Questionnaire Joint structured interview to assess parental involvement in diabetes management tasks
Yates Quality Scale	Study quality (out of 35): 12 (low quality) Treatment quality (out of 9): 1 (low quality) Design quality (out of 26): 11 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Patients were randomly assigned according to age and duration.” Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition not adequately described
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Lask 1979
Methods	RCT. Assessed at pre-treatment, post-treatment and 1 year follow-up.
Participants	End of treatment n = 37 children, 33 families Start of treatment n = 37 children, 33 families Sex of children: not reported Sex of parents: not reported Mean age of children = range 4 to 14 years, mean not reported Mean age of parents = not reported Source = not reported Diagnosis = asthma Mean years of illness = not reported
Interventions	“Family psychotherapy” (FT) Standard care control group Mode of delivery: individual families, face to face Intervention delivered by: mental health professional Training: not reported Duration of intervention (child) = 6 ×1 hr family psychotherapy = 6 hours Duration of intervention (parent) = 6 × 1 hr family psychotherapy = 6 hours
Outcomes	* Extracted measures Child measures Diary cards* Peak expiratory flow rate (PEFR) Forced expiratory volume (FEV) Thoracic gas volume (TGV)
Yates Quality Scale	Study quality (out of 35): 10 (low quality) Treatment quality (out of 9): 2 (low quality) Design quality (out of 26): 8 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Families were then randomly allocated to the experimental (group A) or control group (group B).” Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	High risk	Data were incompletely reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Lehmkuhl 2010
Methods	RCT. 2 arms. Assessed pre and post-treatment.
Participants	End of treatment n = 22 Start of treatment n = 32 Sex of children: 9M,23 F Sex of parents: 2 M, 27 F, 3 unknown Mean age of children = 13.66 (2.43) Mean age of parents = 41.53 (8.14) Source = university-affiliated paediatric endocrinology clinic Diagnosis = type 1 diabetes Mean years of illness = over 6 months
Interventions	“Telehealth Behavioral Therapy” (CBT) “Wait list control” Mode of delivery: individual, phone calls Intervention delivered by: psychologists and Clinical Psychology interns Training: not reported Duration of intervention (child) = 36 phone calls, 9 to 12 hours Duration of intervention (parent) = 36 phone calls, 9 to 12 hours
Outcomes	* Extracted measures Child measures A1c Now* Diabetes Family Behavior Scale, Abbreviated (DFBS)* Diabetes Self-Management Profile (DSMP) Diabetes Family Behavior checklist (DFBC) Diabetes Family Responsibility Questionnaire Parent measures Diabetes Self-Management Profile (DSMP) Diabetes Family Behavior checklist (DFBC) Diabetes Family Responsibility Questionnaire Clinician measures Clinical Global Impression Scale (CGIS) Clinical Global Improvement (CGI)
Yates Quality Scale	Study quality (out of 35): 20 (high quality) Treatment quality (out of 9): 7 (high quality) Design quality (out of 26): 13 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Participants were then randomly assigned to the immediate treatment group or to a 1 month wait-list using a random numbers table.” Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	“All assessments were conducted by an independent rater. The rater was a full-time research assistant.” Comment: unclear whether rater was blind.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	High risk	Data were incompletely reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Levy 2010
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment, 3-month follow-up, 6-month follow-up.
Participants	End of treatment n = 168, 3 months = 143, 6 months = 154 Start of treatment n = 200 Sex of children: 55 M, 145 F Sex of parent: 12M, 188 F Mean age of child = 11.21 (2.55) Mean age of parent = 43.75 (6.35) Source = paediatric Gl Clinics at Seattle Children's Hospital and the Atlantic Health System in Morristown, New Jersey. Seattle area participants were also recruited via local clinics and community-posted flyers. Diagnosis = functional abdominal pain Mean years of illness = 3+ episodes of abdominal pain during a 3-month period
Interventions	“Cognitive-behavioural treatment” (CBT) “Educational intervention” Mode of delivery: individual families, face to face Intervention delivered by: therapists Training: not reported Duration of intervention (child) = 3 × 75 minutes = 4 hours Duration of intervention (parent) = 3 × 75 minutes = 4 hours
Outcomes	* Extracted measures Child measures Functional Disability Inventory* (FDI) Faces Pain Scale-Revised* Child Depression Inventory* (CDI) Child Somatization Inventory (CSI) Multidimensional Anxiety Scale for Children (MASC) Parent measures Functional Disability Inventory (FDI) Faces Pain Scale-Revised Child Somatization Inventory (CSI)
Yates Quality Scale	Study quality (out of 35): 27 (high quality) Treatment quality (out of 9): 7 (high quality) Design quality (out of 26): 20 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomisation was then performed by a different researcher using a computerised random-number generator, stratifying by age.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Randomisation was then performed by a different researcher using a computerised random-number generator, stratifying by age.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“Nurse assessors were blind to the treatment assignment of the children.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Low risk	Data were fully reported after authors responded to data requests. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Ng 2008
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment and 11 weeks follow-up.
Participants	End of treatment n = 27 Start of treatment n = 46 Sex of children: 25 M, 12 F Sex of parents: not reported Mean age of child = 9.24 (1.48) Mean age of parent = not reported Source = paediatric chest clinic of the Prince of Wales Hospital Hong Kong Diagnosis = asthma Mean years of illness = 5.70 (2.41)
Interventions	“We Together-We Success Parallel Group for Children with Asthma and their Parents (WTWS)” (FT) “Control Group” (wait list) Mode of delivery: group, face to face Intervention delivered by: not reported Training: not reported Duration of intervention (child) = 11 × 2 hours = 22 hours Duration of intervention (parent) = 11 × 2 hours = 22 hours
Outcomes	* Extracted measures Child measures Exhaled nitric oxide (eNO)* Spirometry Parent measures Anxiety Subscale of Chinese version Hospital Anxiety and Depression Scale (HADS)* Caretakers' perceived efficacy in the management of child's asthma (self constructed)* The Emotion Scale of Body-Mind-Spirit Well-Being Inventory (BMSWBI) Standard Short Form 12 (SF-12) Chinese (Hong Kong) Version 1 measuring health-related quality of life Patient's adjustment to asthma (self constructed)*
Yates Quality Scale	Study quality (out of 35): 16 (low quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 11 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“A randomised wait-list-controlled clinical trial design was adopted in this study”. Comment: no method described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	High risk	Data were fully reported. No aims or primary outcomes were described in the introduction. Comment: probably some reporting bias.
Niebel 2000
Methods	RCT. 2 arms. Assessed pre-treatment and post-treatment.
Participants	End of treatment n = 47 Start of treatment n = 57 Sex of children: 5 M, 47 F Sex of parents: 0 M, 47 F Mean age of children = 3.9 (2.43) Mean age of parents = 33.9 (1.25) Source = unknown Diagnosis = eczema Mean years of illness = 9.1 years (8.36)
Interventions	“Direct Behavioural Parental Education” “Standardized Video-based Parental Education” “Dermatologic Standard Treatment” Mode of delivery: group and individual, face to face and video-based Intervention delivered by: mental health professional Training: not reported Duration of intervention (child) = 0 Duration of intervention (parent) = 10 × 2 = 20 hours (direct), 1.67 hours (video-based)
Outcomes
Yates Quality Scale	Study quality (out of 35): 11 (low quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 6 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	High risk	Data not fully reported. Comment: probably no reporting bias. Comment: probably no reporting bias.
Olivares 1997
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 9-month follow-up.
Participants	End of treatment n = not reported Start of treatment n = 36 Sex of children: 19M, 17 F Sex of parents: 12M.23 F Mean age of children = not reported Mean age of parents = treatment group = 39.71 (5.47), control group = 40.87 (7.05) Source = not reported Diagnosis = diabetes Mean years of illness = treatment group = 4.76 (3.8) years, control group = 3.72 (2.22) years
Interventions	“Programme to modify parent behaviour” (CBT) “Wait list control” Mode of delivery: group, face to face Intervention delivered by: not reported Training: not reported Duration of intervention (child) = 0 Duration of intervention (parent) = 8 sessions × 70 min = 9 hours 20 min
Outcomes	* Extracted measures Knowledge about behaviour modification* Responsibility for diabetes care* Blood glucose level*
Yates Quality Scale	Study quality (out of 35): 16 (low quality) Treatment quality (out of 9): 4 (low quality) Design quality (out of 26): 12 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	High risk	Data not fully reported. Comment: probably no reporting bias. Comment: probably no reporting bias.
Palermo 2009
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment and 3-month follow-up.
Participants	End of treatment n = 44 Start of treatment n = 48 Sex of children: 13M, 35 F Sex of parents: 7:41 Mean age of children = 14.8 (2.0) Mean age of parents = not reported Source = academic health centre, Pacific Northwest USA Diagnosis = mixed pain conditions Mean years of illness = 30 months
Interventions	“Internet-delivered family cognitive-behavioral therapy” (CBT) “Wait list control group” Mode of delivery: individual families, Internet Intervention delivered by: Internet and online coach. Online coach was a PhD level postdoctoral psychology fellow. Training: 1 year of experience delivering face-to-face CBT to children with chronic pain. Duration of intervention (child) = 4 hours Duration of intervention (parent) = 4 hours
Outcomes	* Extracted measures Child measures Pain diary* Child Activity Limitations Interview* (CALI) Revised Child Anxiety and Depression Scale* (RCADS) Treatment Evaluation Inventory - Short Form Parent measures Adult Responses to Children's Symptoms* (ARCS) Treatment Evaluation Inventory - Short Form
Yates Quality Scale	Study quality (out of 35): 30 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 22 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“A fixed allocation randomisation scheme was used. Specifically, we used blocked randomisation with blocks of 10 to assign participants to the two treatment conditions during the course of randomisation. An online random number generator was used to produce the blocked randomisation. Group assignments were identified by ID number in sealed envelopes. Following completion of all pre-treatment assessments, a research coordinator opened the sealed envelope to reveal the group assignment.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“A fixed allocation randomisation scheme was used. Specifically, we used blocked randomisation with blocks of 10 to assign participants to the two treatment conditions during the course of randomisation. An online random number generator was used to produce the blocked randomisation. Group assignments were identified by ID number in sealed envelopes. Following completion of all pre-treatment assessments, a research coordinator opened the sealed envelope to reveal the group assignment.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	Participants completed questionnaires online
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data were fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Robins 2005
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment and 6 to 12 months following study entry.
Participants	End of treatment n = 69, follow-up = 69 Start of treatment n = 86 Child sex: 30 M, 39 F Parent sex: not reported Mean age of children = 11.34 (2.4) Mean age of parents = not reported Source = community-based primary care physicians and hospital-based paediatric gastroenterologists Diagnosis = recurrent abdominal pain Mean years of illness = 3+ episodes over 3 months
Interventions	“Standard Medical Care plus Short-Term Cognitive-Behavioral Family Treatment” (CBT) “Standard Medical Care” Mode of delivery: group, face to face Intervention delivered by: psychology post-doctoral fellow or pre-doctoral intern Training: not reported Duration of intervention (child) = 5 sessions × 40 minutes = 3 hours 20 minutes Duration of intervention (parent) = 3 sessions × 40 minutes = 2 hours
Outcomes	* Extracted measures Child measures Abdominal Pain Index* (API) Child Somatization Inventory* (CSI) Functional Disability Inventory Child Version* (FDI) School Absences obtained from school attendance records Parent measures Abdominal Pain Index (API) Child Somatization Inventory (CSI) Clinician measures Health service use obtained from physician offices
Yates Quality Scale	Study quality (out of 35): 22 (high quality) Treatment quality (out of 9): 6 (high quality) Design quality (out of 26): 16 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The remaining sample of 86 were randomly assigned using a coin-flip method.” Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented on significant differences between completers and non-completers
Selective reporting (reporting bias)	High risk	Data were incompletely reported. Aims, measures and results were Dartially concordant. Comment: probably some reporting bias.
Sahler 2002
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment and 3-month follow-up.
Participants	End of treatment n = 81 Start of treatment n = 92 Sex of children: not reported Sex of parents: OM, 92 F Mean age of children = 8.32 (5.5) Mean age of mothers = 35.35 (6.6) Source = 6 children's hospitals in USA Diagnosis = cancer Mean years of illness = 2 to 16 weeks from diagnosis
Interventions	“Problem solving therapy” (PST) “Standard psychosocial care” Mode of delivery: individual, face to face Intervention delivered by: mental health professional or doctoral candidate in psychology Training: 3-day workshop Duration of intervention (child) = 0 Duration of intervention (parent) = 8 sessions × 1 hr = 8 hours
Outcomes	* Extracted measures Parent measures Social Problem-Solving Inventory-Cancer* Profile of Mood States*
Yates Quality Scale	Study quality (out of 35): 23 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 14 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomisation was performed centrally, after stratification by site, using a two-block technique that produced a unique sequence for each site, delivered as a set of consecutively numbered envelopes specifying each subject's assignment”. Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Randomisation was performed centrally, after stratification by site, using a two-block technique that produced a unique sequence for each site, delivered as a set of consecutively numbered envelopes specifying each subject's assignment”. Comment: probably done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	Low risk	Data were fully reported after authors responded to requests. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Sahler 2005
Methods	RCT. 2 arms. Assessed pre-treatment, post-treatment and 6 months after T1.
Participants	End of treatment n = 407 Start of treatment n = 430 Sex of children: 219 M, 210 F Sex of parents: 0M.429 F Mean age of children at diagnosis = 7.6 Mean age of mothers = 35.5 Source = 7 sites is USA + 1 site in Israel Diagnosis = cancer Mean years of illness = 2 to 16 weeks from diagnosis
Interventions	“Usual psychosocial care plus problem-solving therapy” (PST) “Usual psychosocial care” Mode of delivery: individual, face to face Intervention delivered by: not reported Training: not reported Duration of intervention (child) = 0 Duration of intervention (parent) = 8 × 1 hr = 8 hours
Outcomes	* Extracted measures Parent measures Profile of Mood States (POMS)* Beck Depression Inventory-ll (BDI-II)* Social Problem-Solving Inventory-Revised (SPSI-R)* NEO-Five Factor Inventory (NEO-FFI) Impact of Event Scale-Revised (IES-R)
Yates Quality Scale	Study quality (out of 35): 15 (low quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 10 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (lection bias)	Unclear risk	“Randomisation was performed centrally.” Comment: method not described.
Allocation concealment (selection Dias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (etection bias)	Unclear risk	No description found in text. Comment: probably not done.
ncomplete outcome data (attrition Dias)	Unclear risk	Attrition was reported, but no data were presented describing equivalence between completers and non-completers
Selective reporting (reporting bias)	Unclear risk	Data were fully reported after authors responded to requests. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Sanders 1994
Methods	RCT. 2 arms. Assessed at pre-treatment, post-treatment, 6-month follow-up, 12-month follow-up.
Participants	End of treatment n = 44 Start of treatment n = 44 Sex of children: 16 M,28 F Sex of parents: not reported Mean age of children = 9.22 (1.9) Mean age of parents = 39.3 (4.9) Source = not reported Diagnosis = recurrent abdominal pain Mean years of illness = 44 months (37.76)
Interventions	“Cognitive-behavioral family intervention” (CBT) “Standard paediatric care” Mode of delivery: individual, face to face Intervention delivered by: Clinical Psychologists Training: not reported Duration of intervention (child) = 6 × 50 minutes = 5 hours Duration of intervention (parent) = 6 × 50 minutes = 5 hours
Outcomes	* Extracted measures Child measures Pain diary* Videotaped vignettes, assessment of children's self coping Parent measures Child Behavior Checklist CBCL* Videotaped vignettes, assessment of maternal care giving* Parent Observation Record (POR) Treatment expectancies Measures of relapse - interview Satisfaction with treatment
Yates Quality Scale	Study quality (out of 35): 18 (high quality) Treatment quality (out of 9): 5 (high quality) Design quality (out of 26): 13 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“The study used a randomised group comparison design with two treatment conditions.” Comment: method not described.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Unclear risk	No description found in text. Comment: probably not done.
Incomplete outcome data (attrition bias)	High risk	Attrition was not adequately described
Selective reporting (reporting bias)	Unclear risk	Data were incompletely reported. Aims, measures and results were fully concordant. Comment: probably some reporting bias.
Seid 2010
Methods	RCT. 3 arms. Assessed pre-treatment, post-treatment and 6-month follow-up.
Participants	End of treatment n = 204, 6-month follow-up n = 188 Start of treatment n = 252 Sex of children: 154 M, 98 F Sex of parents: 9M.244F Mean age of children = 7.37 (3.07) Mean age of parents = not reported Source = federally qualified health centres, a commercial HMO, school/daycare, local asthma initiatives and self referrals in San Diego, CA, USA Diagnosis = asthma Mean length of illness = 44 months (37.76)
Interventions	“Problem-Solving Skills Training + Care Coordination” (PST + Asthma Education) “In Home Asthma Education + Care Coordination” (Asthma Education) “Standard care wait-list control” Mode of delivery: individual families, face to face Intervention delivered by: Master's level health educator (PST), paraprofessional asthma home visitors (care co-ordination) Training: 2-week training Duration of intervention (PST + Asthma Education) = 6 × 45 to 60 minutes Duration of intervention (Asthma Education) = 5 × 45 to 60 minutes
Outcomes	* Extracted measures Child measures Pediatric Quality of Life Inventory Asthma Module Asthma Symptoms Scale (PedsQL Asthma) Parent measures Pediatric Quality of Life Inventory (PedsQL)* Health Service Use self report
Yates Quality Scale	Study quality (out of 35): 30 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 21 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Blocked randomisation, stratified by site of care and disease severity was used. Prepared randomisation lists were created by the statistician and concealed until intervention assignment.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Blocked randomisation, stratified by site of care and disease severity was used. Prepared randomisation lists were created by the statistician and concealed until intervention assignment.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“Bilingual, bicultural research staff, blinded to the intervention group, administered surveys in English or Spanish in participants' homes.” Comment: probably done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data fully reported. Aims, measures and results were fully concordant. Comment: probably no reporting bias.
Stehl 2009
Methods	RCT. 2 arms. Assessed pre-treatment and 1 month post-treatment.
Participants	End of treatment n = 48 families, 92 caregivers Start of treatment n = 76 families, 152 caregivers received intervention Sex of children: 41 M, 35 F Sex of parents = not reported Mean age of children = 6 years Mean age of primary caregiver = 36 years Source = oncology service Diagnosis = cancer Mean years of illness = after diagnosis
Interventions	#x0201C;Surviving Cancer Competently Intervention Program-Newly Diagnosed” (CBT) “Standard Psychosocial Care” Mode of delivery: group, face to face, CD-ROM based multiple family discussion groups Intervention delivered by: psychology fellows, psychology intern, Master's level psychologist and doctoral-level nurse Training: 18 hours of didactic and experiential training Duration of intervention (children) = 3 × 45 minutes + 3 booster sessions Duration of intervention (parents) = 3 × 45 minutes + 3 booster sessions
Outcomes	* Extracted measures Parent measures State Trait Anxiety Inventory* (STAI) Impact of Event Scale-Revised (IES-R) Acute Stress Disorder Scale (ASDS) Programme Evaluation Clinicians' measures Social Work Activity Form Child Life Activity Form Intensity of Treatment Rating Scale (ITR-2)
Yates Quality Scale	Study quality (out of 35): 25 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 17 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomization was completed by a predetermined concealed random assignment list maintained by a staff member unaware of patient identity.” Comment: probably done.
Allocation concealment (selection bias)	Low risk	“Randomization was completed by a predetermined concealed random assignment list maintained by a staff member unaware of patient identity.” Comment: probably done.
Blinding of outcome assessment (detection bias)	Low risk	“Add data collection took place at the hospital at a time and location of convenience for the family and was conducted by research assistants.” Comment: probably done.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Low risk	Data fully reported. Aims, measures and results are fully concordant. Comment: probably no reporting bias.
Wade 2006
Methods	RCT. 2 arms. Assessed pre and post-treatment
Participants	End of treatment n = 32 children and their parents Start of treatment n = 37 children and their parents Sex of children: 21 M, 11 F Sex of parents: not reported Mean age of children = 10.83 (2.94) Mean age of parents = not reported Source = trauma registry at Cincinnati Children's Hospital Medical Center Diagnosis = traumatic brain injury Mean years of illness = 8.78 (4.53)
Interventions	“Family-centered problem-solving intervention” (PST) “Usual Care” Mode of delivery: individual families, face to face Intervention delivered by: 5th year Clinical Psychology graduate student Training: 2 months Duration of intervention (children) = 7 × 75 minutes = 8 hours 45 minutes to 11 hours 40 minutes + up to 4 individualised sessions Duration of intervention (parents) = 7 × 75 minutes = 8 hours 45 minutes to 11 hours 40 minutes + up to 4 individualised sessions
Outcomes	* Extracted measures Child measures Conflict Behavior Questionnaire* Treatment satisfaction Parent measures Child Behavior Checklist* (CBCL) Conflict Behavior Questionnaire* (CBQ) Brief Symptom Inventory* (BSI) Treatment satisfaction
Yates Quality Scale	Study quality (out of 35): 22 (high quality) Treatment quality (out of 9): 9 (high quality) Design quality (out of 26): 13 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Families were randomly assigned to the family-centred problem-solving intervention or usual care group using a random numbers table.” Comment: probably done.
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	High risk	“Interviewers were also upper-level psychology graduate students who received extensive training.” Comment: no suggestion that they were blinded.
Incomplete outcome data (attrition bias)	Low risk	Attrition was reported, no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were fully reported after authors responded to requests. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Wade 2006b
Methods	RCT. 2 arms. Assessed pre-treatment and at session 7 of 8.
Participants	End of treatment n = 41 (40 analysed) Start of treatment n = 46 Sex of children: 23 M, 17 F Sex of parents: not reported Mean age of children = 11.00 (3.27) Mean age of parents = not reported Source = trauma registry at Cincinnati Children's Hospital Medical Center Diagnosis = traumatic brain injury Mean years of illness = 13.73 (7.10) months since injury
Interventions	“Family Problem Solving” (PST) “Internet Resources Control” Mode of delivery: individual, online and video conferencing Intervention delivered by: Clinical Psychology graduate student Training: 2 months Duration of intervention (children) = 8 core modules, 6 supplementary modules, time not reported Duration of intervention (parents) = 8 core modules, 6 supplementary modules, time not reported
Outcomes	* Extracted measures Parent outcomes Family Assessment Device (FAD) Family Burden of Injury Interview subscales (FBII) Likert scales of global family problem-solving, communication and behaviour management Child Behavior Checklist Internalizing Problems* (CBCL) Home and Community Social Behavior Scale (HCSBS) Social Problem-Solving Index (SPSI-short version) Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index (GSI) Center for Epidemiologic Studies Depression Scale* (CES-D) Anxiety Inventory (Al) Online usage questionnaire Website Evaluation Questionnaire (WEQ)
Yates Quality Scale	Study quality (out of 35): 25 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 17 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Families were randomly assigned to family problem-solving or internet resources comparison via a computer programme.” Comment: probably done
Allocation concealment (selection bias)	Unclear risk	No description found in text. Comment: probably not done.
Blinding of outcome assessment (detection bias)	Low risk	“Given the nature of the study, neither the participants nor the research assistant was blind to group assignment. The primary outcome measures were based on parent and child report and therefore not dependent on the judgments of the research staff.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was not reported, but no significant differences between completers and non-completers was described
Selective reporting (reporting bias)	Unclear risk	Data were fully reported after authors responded to requests. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Wade 2011
Methods	RCT. 2 arms. Assessed pre-treatment and post-treatment.
Participants	End of treatment n = 35 Start of treatment n = 42 Sex of children: 17M.23 F Sex of parents: not reported Mean age of children = 14.25 (2.29) Mean age of parents = not reported Source = inpatient rehabilitation unit of 2 urban children's hospitals Diagnosis = traumatic brain injury Mean years of illness = 9.54 (4.97) months since injury
Interventions	“Teen Online Problem Solving” (PST) “Internet Resource Comparison” Mode of delivery: individual, internet and video conferencing Intervention delivered by: staff psychologist + Clinical Psychology graduate students Training: multi-day training Duration of intervention (children) = 10 core modules, 6 supplementary sessions, time not reported Duration of intervention (parents) = 10 core modules, 6 supplementary sessions, time not reported
Outcomes	* Extracted measures Child measures Youth Self Report* (YSR) Interaction Behaviour Questionnaire* (IBQ) Behavioral Rating Inventory of Executive Functioning Parent measures Child Behaviour Checklist* (CBCL) Interaction Behaviour Questionnaire* (IBQ) Behavioral Rating Inventory of Executive Functioning (BRIEF)
Yates Quality Scale	Study quality (out of 35): 22 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 14 (low quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Families were randomly assigned to either teen online problem-solving or internet resource group by use of a randomisation scheme that stratified participants on the basis of the adolescent's gender and race/ethnicity to ensure comparable diversity in each group.” Comment: method is not fully described.
Allocation concealment (selection bias)	Unclear risk	“Families were randomly assigned to either teen online problem-solving or internet resource group by use of a randomisation scheme that stratified participants on the basis of the adolescent's gender and race/ethnicity to ensure comparable diversity in each group.”
Blinding of outcome assessment (detection bias)	Low risk	“Given the nature of the study we were unable to conceal group assignment from the participants and research staff; however, the primary outcome measures were based on parent and teen report and therefore not dependent on judgments of research staff.” Comment: non-blinding of participants and research staff justified.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, no data were presented on equivalence between completers and non-completers
Selective reporting (reporting bias)	Unclear risk	Data were fully reported after authors responded to requests. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Wysocki 1999
Methods	RCT. 3 arms. Assessed pre-treatment, 3 months (post-treatment), 6-month follow-up and 12-month follow-up.
Participants	End of treatment n = 115 (post-treatment), 113 (6-month follow-up), 108 (12-month follow-up) Start of treatment n = 119 children Sex of children: 50 M, 69 F Sex of parents: 82 M, 117 F Mean age of children = 14.3 (1.4) Mean age of parents = not reported Source = Missouri and Florida Diagnosis = type 1 diabetes Mean years of illness = 5.0 (3.8)
Interventions	“Behavioral Family Systems Therapy (BFST)” (FT) “Education and Support Group” (ES) “Standard Care” Mode of delivery: individual for BFST, group for ES, face to face Intervention delivered by licensed Clinical Psychologists Training: 150 hours Duration of intervention (children) = 10 sessions, time not reported Duration of intervention (parents) = 10 sessions, time not reported
Outcomes	* Extracted measures Child measures Parent-Adolescent Relationship Questionnaire (PARQ)* Issues Checklist (IC) 24 Hour Recall Interview of Conflict Situations Teen Adjustment to Diabetes Scale (TADS)* Diabetes Responsibility and Conflict (DRC) 24 Hour Recall Interview of IDDM Self-Care Self-Care Inventory (SCI) Glycated haemoglobin* Parent measures Parent-Adolescent Relationship Questionnaire (PARQ)* Issues Checklist (IC) 24 Hour Recall Interview of Conflict Situations Teen Adjustment to Diabetes Scale (TADS) Diabetes Responsibility and Conflict (DRC) 24 Hour Recall Interview of IDDM Self-Care Self-Care Inventory (SCI) Parent-reported health service use
Yates Quality Scale	Study quality (out of 35): 23 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 15 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“The research scientist at the opposing centre randomly assigned each family, without knowledge of the family's baseline status on any of the outcome measures to one of three conditions.” Comment: method not fully described.
Allocation concealment (selection bias)	Unclear risk	“Randomisation was stratified by the adolescent's gender and treatment centre so that each centre enrolled a similar number of boys and girls into the three groups.”
Blinding of outcome assessment (detection bias)	Unclear risk	“A research assistant administered questionnaires at evaluation sessions; the research assistant completed telephone interviews during the 2 weeks preceding each of the four evaluations.” Comment: blinding not described.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented on equivalence between completers and non-completers
Selective reporting (reporting bias)	High risk	Data not fully reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
Wysocki 2006
Methods	RCT. 3 arms. Assessed at pre-treatment, 6 months (post-treatment), 12-month follow-up, 18-month follow-up.
Participants	End of treatment n = 92 (post-treatment), 88 (12-month follow-up), 85 (18-month follow-up) Start of treatment n = 104 children (number of caregivers not reported) Sex of children: 57M,47 F Sex of parents: not reported Mean age of children = 14.2 (1.9) Mean age of parents = not reported Source = 2 paediatric centres in the Southeast and Midwest USA Diagnosis = type 1 diabetes or insulin-treated type 2 diabetes Mean years of illness = 5.5 (3.4)
Interventions	“Behavioral Family Systems Therapy for Diabetes (BFST-D)” (FT) “Educational Support Group” “Standard Care” Mode of delivery: individual families, face to face Intervention delivered by: licensed Clinical Psychologist, Social Worker Training: trained in BFST-D Duration of intervention (BFST-D) = 12 sessions, time not reported Duration of intervention (ES) = 12 × 1.5hr sessions
Outcomes	* Extracted measures Child measures Parent-Adolescent Relationship Questionnaire (PARQ)* Glycosylated haemoglobin (HbA1c)* Diabetes Responsibility and Conflict (DRC) Diabetes Self-Management Profile (DSMP) Family problem solving discussions coded using Interaction Behavior Code Parent measures Parent-Adolescent Relationship Questionnaire (PARQ)* Diabetes Responsibility and Conflict (DRC) Diabetes Self-Management Profile (DSMP) Family problem solving discussions coded using Interaction Behavior Code
Yates Quality Scale	Study quality (out of 35): 26 (high quality) Treatment quality (out of 9): 8 (high quality) Design quality (out of 26): 18 (high quality)
Notes
Risk of bias table
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“A three-group, randomised treatments design was used.” Comment: method not described fully.
Allocation concealment (selection bias)	Unclear risk	“Families were stratified by HbA1c”
Blinding of outcome assessment (detection bias)	Low risk	“Raters were unaware of the family's identity or group assignment or of when the recording was made.” Comment: probably done.
Incomplete outcome data (attrition bias)	Unclear risk	Attrition was reported, but no data were presented on equivalence between completers and non-completers
Selective reporting (reporting bias)	High risk	Data were incompletely reported. Aims, measures and results were partially concordant. Comment: probably some reporting bias.
footnote
CBT: cognitive behavioural therapy; Gl: gastrointestinal; HMO: health maintenance organisation; MST: multisystemic therapy; PSST: problem solving skills training; PST: problem solving therapy; RCT: randomised controlled trial