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. 2018 Dec 22;2018(12):CD012488. doi: 10.1002/14651858.CD012488.pub2

Kashikar‐Zuck 2005.

Methods Study design: randomised controlled trial
Study grouping: cross‐over
Setting: outpatient clinic
Outcome measures: Children’s Depression Inventory (CDI); Pain severity visual analogue scale (VAS) completed at baseline, post‐intervention (8 weeks) and 16 weeks
Participants Type of chronic illness: juvenile primary fibromyalgia syndrome
Inclusion criteria: Aged 13‐17 years, diagnosed with juvenile primary fibromyalgia; stabilised on medication for at least 4 weeks prior to enrolment; average pain level of at least 3 (mild pain) over the preceding 2 weeks on a 10 cm visual analogue scale; functional disability score greater than 7 (mild disability) on the Functional Disability Inventory
Exclusion criteria: existing comorbid rheumatic disease; documented developmental delay, or impairment; major depressive disorder
Baseline characteristics
Overall
Number: 30
Sex (males (%)): 0 (0%)
Age in years (SD): mean 15.38 (1.26)
Severity of chronic illness: average pain rating (VAS) of 5.30 or more (moderate)
Ethnicities: 28 (93%) Caucasian, 2 (7%) African‐American
Depressive symptoms – rating (SD): not reported
Coping Skills Training
Number: 15
Sex (males (%)): 0 (0%)
Age in years (SD): not reported
Severity of chronic illness: average pain rating (VAS) of 5.71/10
Ethnicities: not reported
Depressive symptoms – rating (SD): mean CDI T score = 56.07 (12.42)
Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): subthreshold
Self‐monitoring
Number: 15
Sex (males (%)): 0 (0%)
Age in years (SD): not reported
Severity of chronic illness: average pain rating (VAS) of 5.30/10
Ethnicities: not reported
Depressive symptoms – rating (SD): mean CDI T score = 48.46 (12.89)
Depressive symptoms ‐ category (none/subthreshold/clinical range/unsure): subthreshold
Anxiety symptoms ‐ rating (SD): not reported
Baseline differences: no significant differences
Interventions Intervention characteristics
Coping skills training
Audience: child and parent
Description of intervention: psychoeducation, relaxation strategies; distraction and activity pacing techniques; cognitive techniques to deal with negative thoughts and mood difficulties; problem‐solving to anticipate and plan for difficult or stressful situations and improve sleep hygiene
Modality: child, with parent involved in 3 sessions
Dose: 6 weekly 60 minutes sessions and 2 telephone follow‐ups toward the end of 8 weeks
Manualised or non‐manualised: manualised
Parent or caregiver involvement: parents involved in 3 sessions
Therapist involvement: delivered sessions
Self‐monitoring
Audience: child
Description of intervention: self‐monitoring using weekly diaries for 8 weeks
Modality: individual
Dose: no contact, diaries provided, and outcome measures collected at 4 and 8 weeks
Manualised or non‐manualised: non‐manualised
Parent or caregiver involvement: no involvement
Therapist involvement: no involvement
Outcomes Specific depression measures: Children’s Depression Inventory (CDI)
Improvement in function: Functional Disability Inventory (FDI)
Status of long‐term physical condition: Pain rating Visual Analogue Scale (VAS)
Identification Sponsorship source: Cincinnati Children’s Hospital Research Foundation, National Institutes of Health
Country: USA
Authors name: Susmita Kashikar‐Zuck
Institution: Cincinnati Children’s Hospital Medical Center
Email: Susmita.Kashikar‐Zuck@cchmc.org
Address: Psychology Division, MLC 3015Cincinnati Children’s Hospital Medical CenterCincinnati, OH 45229.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: random allocation using a computer generated pseudo random number table and block allocation
Allocation concealment (selection bias) Low risk Judgement comment: sealed envelope opened by blinded researcher
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Judgement comment: unclear about participants. Research assistants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Judgement comment: rheumatologists and occupational therapists conducting 'tender point' examinations blinded to group. All other outcome measures self‐report
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Judgement comment: few dropouts from either group, management of missing data using ITT with last available value carried forward for missing data
Selective reporting (reporting bias) Low risk Judgement comment: all planned outcomes reported
Other bias Low risk Judgement comment: no other sources of bias evident