Griffiths 1996.

Methods	Study design: randomised controlled trial Study grouping: parallel group Setting: community sample recruited via newspaper advertisements Measures used: Children’s Depression Scale (CDS); Children’s Manifest Anxiety Scale (CMAS) completed at baseline and post‐intervention (8 weeks)
Participants	Type of chronic illness: headaches/migraines Inclusion criteria: aged 10‐12 years; at least one headache per week for 6 months; could attend sessions with a parent; diagnosis of migraine or tension headache or combined migraine/tension headache Exclusion criteria: currently receiving psychological treatment for headaches Baseline characteristics Overall Sex (males (%)): 21 (50%) Age in years (SD): not reported Type of chronic illness: 8 (19%) migraine; 14 (33%) tension; 20 (48%) combined Ethnicities: not reported Depressive symptoms – rating (SD): not reported Anxiety symptoms ‐ rating (SD): not reported Clinic‐based cognitive behaviour therapy Number: 15 Sex (males (%)): 7 (46.7%) Age in years (SD): 11.4 (0.58) Type of chronic illness: 2 (13%) migraine; 9 (60%) tension; 4 (27%) combined Ethnicities: not reported Depressive symptoms – rating (SD): CDS 3.0 (0.9) Anxiety symptoms ‐ rating (SD): CMAS 14.5 (6.3) Home‐based cognitive behaviour therapy Number: 12 Sex (males (%)): 7 (46.7%) Age in years (SD): 11.5 (0.58) Type of chronic illness: 3 (20%) migraine; 4 (27%) tension; 8 (53%) combined Ethnicities: not reported Depressive symptoms – rating (SD): CDS 2.7 (0.7) Anxiety symptoms ‐ rating (SD): CMAS 11.7 (4.9) Waiting‐list control Number: 27 Sex (males (%)): 7 (58.3%) Age in years (SD): 11.1 (0.58) Type of chronic illness: 3 (25%) migraine; 1 (8%) tension; 8 (67%) combined Severity of chronic illness: chronicity in years: 1 (1); 1‐2 (1); 2‐5 (7); 5 (3) Ethnicities: not reported Depressive symptoms – rating (SD): CDS 2.8 (0.9) Anxiety symptoms ‐ rating (SD): CMAS 15.6 (9.0) Baseline differences: Group 1 (clinic‐based sample) had more males than females and more participants with tension headache than migraine or combined headache). Group 2 (home‐based sample) had more females than males and more participants with combined headache than migraine or tension headache alone. Group 3 (control sample) had more males than females and more combined headache than migraine or tension headache alone.
Interventions	Intervention characteristics Clinic‐based cognitive behaviour therapy Audience: child Description of intervention: 8 sessions cognitive behaviour therapy program Modality: group Dose: 8 weekly sessions of 90 minutes duration Manualised or non‐manualised: manualised Parent or caregiver involvement: parents attended an assessment session and were telephoned weekly by therapists between weeks 2‐6 Therapist involvement: delivered sessions and completed follow‐up phone calls Home‐based cognitive behaviour therapy Audience: child Description of intervention: 8 sessions cognitive behaviour therapy program. Treatment was delivered by a work at home manual, except treatment sessions 1, 4, and 8 which were completed at the clinic. Dose: individual Dose: 8 weekly sessions of 90 minutes duration Manualised or non‐manualised: manualised Parent or caregiver involvement: completion of assessment session; participation in two brief monitoring phone calls lasting between 5‐12 minutes Therapist involvement: sessions 1, 4, and 8 delivery plus brief phone calls to parents at weeks 2 and 6 Waiting‐list control Audience: child Description of intervention: self‐monitoring of headaches and medication intake. Time required and duration, including homework: 8 weeks Parent or caregiver involvement: completion of assessment session; participation in two brief monitoring phone calls lasting between 5‐12 minutes
Outcomes	Specific depression measures: Children's Depression Scale (CDS) Change anxiety measures: Children's Manifest Anxiety Scale (CMAS)
Identification	Sponsorship source: not stated Country: Australia Authors name: Jennifer D. Griffiths Institution: University of Western Australia Email: not stated Address: Department of Pychology, The University of Western Australia, Nedlands, Perth, Australia 6907
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Judgement comment: randomisation not clearly described
Allocation concealment (selection bias)	Unclear risk	Judgement comment: allocation concealment not clearly described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Judgement comment: blinding of participants not clearly described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Judgement comment: self‐report measures
Incomplete outcome data (attrition bias) All outcomes	High risk	Judgement comment: only full datasets were analysed. Nine participants dropped out during the study. Reasons for doing so were not adequately described.
Selective reporting (reporting bias)	High risk	Judgement comment: only some data (e.g. anxiety and depression scores pre/post) presented in numerical form. Other data (e.g. headache scores) presented graphically, making it impossible to use in this review. Author could not be contacted for clarification as no email address provided and not on ResearchGate. Data collected more than 10 years ago, so unlikely to be available via institution.
Other bias	High risk	Judgement comment: the intervention was devised by the study authors