Clarke 2005.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: At least one recent dispense of an SSRI antidepressant medication prescribed by a paediatric PCP. Current, research‐ascertained DSM episode of major depression Inclusion criteria:  Adolescents 12 to 18 years old Exclusion criteria:  Chart indication of schizophrenia or significant developmental/intellectual disability.  Extreme suicidal risk that resulted in hospitalisation Age: Mean 15.3 years Gender: 78% female Ethnicity: 14% ethnic minority Country: United States Sample size (randomised): Total participants 152, intervention 77, control 75
Interventions	Treatment: Brief CBT plus treatment as usual SSRIs Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Paediatric primary care provider (PCP), psychologist/CBT (CM), psychologist (MH specialist) 2) a structured management plan: All patients were being treated with an SSRI at enrolment. In addition those in the treatment group received brief CBT based on adult and adolescent depression programmes. Acute phase: After initial decision making session (session 1), CBT began with a choice of either four sessions of cognitive restructuring or four sessions of behavioural activation. A workbook was provided. After completion of the first module (sessions 2–5) progress was evaluated and if appropriate the second module commenced (if recovered the youth entered maintenance phase). The second module (sessions 6–9) consisted of the skills training approach not delivered in the first module. The acute phase also aimed to maximise SSRI medication adherence by reviewing compliance, reported benefits/side effects, and risk of discontinuation. Limited psychoeducation about the benefits of SSRI medication and the importance of adherence was provided Maintenance phase: CM made brief telephone calls after completing acute sessions 3) scheduled patient follow‐ups: Acute phase: 6‐9 sessions of CBT delivered by CM; maintenance phase: CMs made brief telephone calls to patients 1, 2, 3, 5, 7, and 9 months after completing acute sessions. Also option to request as many as six additional, in‐person sessions during the year long continuation phase 4) enhanced inter‐professional communication: On‐going communication with PCP was part of protocol. CMs received weekly supervision from study psychologists Control: Treatment as usual enhanced as all patients were being treated with an SSRI at enrolment
Outcomes	Depression (CES‐D): 6, 12, 26, 52 weeks Medication use: 12 weeks Quality of Life (mental and physical health): 6, 12, 26, 52 weeks Satisfaction: 6, 12, 26, 52 weeks
Notes	CM: case manager; CBT: cognitive behaviour therapy; CES‐D: Centre for Epidemiological Studies Depression; DSM: Diagnostic and Statistical Manual; MH: mental health; PCP: primary care provider; SSRI: selective serotonin reuptake inhibitor
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Block randomisation. Insufficient information available to assess
Allocation concealment (selection bias)	Unclear risk	Insufficient information available to assess
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (CES‐D) was: overall 25/152(16%), 12/77(16%) intervention and 13/75(17%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis.
Selective reporting (reporting bias)	Unclear risk	Insufficient information available to assess
Other bias	Unclear risk	Insufficient information available to assess
Implementation Integrity	Low risk	Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessor was not aware of treatment allocation