Law 2015.

Methods	Study design: randomised controlled trial Study grouping: parallel group
Participants	Baseline Characteristics Internet‐delivered CBT for headache Sex (males (%)): 7 (15.9%) Age: 14.6 (1.8) Chronic illness: migraine 21(25.3), tension 16(19.3), both 22(26.5), other 24(28.9) Severity of chronic illness: total headache days 5.82 (1.72)/7, pain intensity 4.97 (2.47)/10 Ethnicity: 43 (97.7) white, 0 (0) black, 1 (2.3) Asian, 0 (0) multiracial Specialised headache treatment Sex (males (%)): 8 (20.5%) Age: 14.3 (1.6) Chronic illness: migraine 14 (35.9), tension 6 (15.4), both 9 (23.1), other 10 (25.6) Severity of chronic illness: total headache days 5.18 (2.00)/7, pain intensity 4.35 (2.15)/10 Ethnicity: 33 (84.6) white, 1 (2.6) black, 2 (5.1) Asian, 3(7.7) multiracial Overall Sex (males (%)): 15 (18.1%) Age: 14.5 (1.7) Chronic illness: migraine 21 (25.3), tension 16 (19.3), both 22 (26.5), other 24 (28.9) Severity of chronic illness: total headache days 6 (no SD), pain intensity 4.5 (no SD)/10 Ethnicity: 76 (91.6) white, 1 (1.2) black, 3 (3.6) Asian, 3 (3.6) multiracial Included criteria: (1) age 11 to 17 years; (2) recurrent headache for 3 months or more as diagnosed by a paediatric neurologist; and (3) the adolescent was a new patient being evaluated in the headache clinic. "During the first clinic visit, a paediatric neurologist assigned a headache diagnosis based on the International Classification of Headache Diagnoses‐II (ICHD‐II). For this project, diagnoses were grouped as migraine; tension‐type headache; migraine and tension‐type headache; or other headache disorders." (p. 1412) Excluded criteria: (1) the adolescent had a comorbid chronic medical condition such as diabetes, cancer, or sickle cell disease; (2) the adolescent had a developmental disability as reported by their parent; (3) the parent or adolescent was non‐English speaking; or (4) the family did not have regular access to the Internet. Pretreatment: no significant differences in demographics or baseline outcome measurements between groups.
Interventions	Intervention Characteristics Internet‐delivered CBT for Headche Type of e‐health intervention: Web‐MAP (Web‐based Management of Adolescent pain) ‐ child and parent versions Audience: child version and parent versions Number of modules: 8 child modules, 8 parent modules Time required and duration: 30 min per module (approximately 9 hours per family (4 hours for adolescents, 4 for parents and 1 hour online couch time)) Description: for the Internet CBT group, the web programme was adjunctive to medical care as prescribed by the headache clinic" (p. 1412) Medication management N = 27, psychological therapy N = 10, physical therapy N = 12. Psychological included CBT for pain management, biofeedback, or bot Psychotherapeutic modality: CBT Parent or caregiver involvement: parents completed modules on pain education and goal setting, operant training, communication strategies, modelling and cognitive strategies, sleep and lifestyle interventions, and relapse prevention and maintenance. Parent or caregiver time involved: 30 min per module (4 h in total) Therapist involvement and description: review of online assignments by PhD‐level psychology post‐doctoral fellow and asynchronous feedback regarding review of progress, encouragement of skills practice and problem‐solving barriers to implementing skills Therapist time involved: 5 min per assignment = 60 min per family Description of modules: "Adolescents completed modules on pain education and goal setting, relaxation training, distraction strategies, cognitive strategies, sleep and lifestyle interventions, and relapse prevention and maintenance. Parents completed modules on pain education and goal setting, operant training, communication strategies, modelling and cognitive strategies, sleep and lifestyle interventions, and relapse prevention and maintenance." Related papers: Palermo 2009 Devices: web‐based Based on a manual or manualised: manual developed for clinicians to guide responses Includes biofeedback: not applicable Includes homework or assignments: in six of the eight modules, parents and adolescents were given behavioral assignments focused on practice of skills taught in that module. Participants were instructed to work on the assignment for 1 week, and then to log back into the website to report on their progress with learning the skills in that module. These assignments were similar to weekly assignments used in face‐to‐face CBT for pain management. Assignment completion was required before participants were allowed to move on to the next module." (p. 1416) Specialised headache treatment Type of e‐health intervention: participants received one or more of the following interventions as recommended by their providers at the headache clinic: medication management (N = 21), psychological therapy (N = 6), and physical therapy (N = 11). Psychological therapy included face‐to‐face cognitive behavioral therapy for pain management, biofeedback, or both. Following completion and receipt of their 3 month follow‐up assessment, families were offered the opportunity to receive Internet CBT using the same procedures below. Of the 39 families in the specialized headache treatment group, 27 (69.2%) chose to access the Internet CBT programme after the 3 month follow‐up assessment. Audience: child only Number of modules: variable number Time required and duration: variable over 8 weeks Description: "All participants continued with the medical care recommended by the headache clinic". (p. 1412) Psychotherapeutic modality: variable, including CBT, biofeedback for some participants Parent or caregiver involvement: nil Parent or caregiver time involved: nil Therapist involvement and description: as per routine care Therapist time involved: as per routine care Description of modules: N/A Related papers: N/A Devices: nil Based on a manual or manualised: variable Includes biofeedback: sSome participants only Includes homework or assignments: unknown
Outcomes	Change in severity of depression symptoms Outcome type: continuous outcome Scale: CDI Unit of measure: points Direction: lower is better Data value: endpoint Change in caseness of depression Outcome type: dichotomous outcome Direction: higher is better Data value: endpoint Treatment acceptability (child‐related) Outcome type: dichotomous outcome Direction: higher is better Data value: endpoint Improvement in QOL Outcome type: continuous outcome Direction: higher is better Data value: endpoint Change in severity of anxiety Outcome type: continuous outcome Direction: lower is better Data value: endpoint Change in caseness of anxiety Outcome type: dichotomous outcome Direction: lower is better Data value: endpoint Suicide‐related behaviour Outcome type: continuous outcome Direction: lower is better Data value: endpoint Functioning Outcome type: continuous outcome Direction: lower is better Data value: endpoint Notes: activity limitation rated on Child Activity Limitations Interview (CALI): 21 activities, 7 chosen and rated 0 to 4 (total 0 to 32) Status of long‐term physical condition (LTPC) Outcome type: continuous outcome Direction: lower is better Data value: endpoint Notes: Date for total headache days per week out of 7, pain intensity 0 to 10 scale ‐ mean over 7 days also recorded in article Adherence to LTPC treatment Outcome type: continuous outcome Direction: higher is better Data value: endpoint School attendance Outcome type: continuous outcome Direction: higher is better Data value: endpoint Economic Benefits Outcome type: continuous outcome Direction: higher is better Data value: endpoint
Identification	Sponsorship source: supported by Grant K24HD060068 from the National Institutes of Health/National Instituteof Child Health and Human Development (PI: Palermo) Country: USA Setting: multidisciplinary paediatric headache clinic at an academic health centre in north eastern United States Comments: no comment Authors name: Emily F. Law Institution: Seattle Children’s Research Institute Email: emily.law@seattlechildrens.org Address: M/S CW8‐6, P.O. Box 5371, Seattle, WA98145‐5005, USA
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Block randomisation with blocks of 10 was used to assign participants to one of the two treatment conditions. An online number generator was used to produce the blocked randomization. Participants were allocated in a 1:1 ratio."
Allocation concealment (selection bias)	Low risk	Quote: "allocated in a 1:1 ratio. Group assignments were identified by ID number in an excel spreadsheet that was password protected and accessible only to a research coordinator who was blinded to participant recruitment, screening, and informed consent. Following completion of all pre‐treatment assessments, the research coordinator accessed the excel spreadsheet to reveal the group assignment. This information was then programmed into the Web‐MAP system, which generated a message on the website to each trial participant revealing the instructions for their treatment assignment. Because of the nature of the intervention, it was not possible to blind participants or research staff to group status. Assessment Procedures. Prior to randomisation, participants"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Because of the nature of the intervention, it was not possible to blind participants or research staff to group status."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "A research coordinator who was blinded to group status conducted all assessment procedures that occurred in the clinic."
Incomplete outcome data (attrition bias) All outcomes	High risk	Judgement comment: Numbers in consort diagram do not match numbers on Table 2. More than 10% data missing post‐intervention.
Selective reporting (reporting bias)	Unclear risk	Judgement comment: The trial was not pre‐registered. No trial protocol available.
Other bias	High risk	Judgement comment: trial conducted by those who developed the intervention