Wysocki 2001.

Methods	At the end of baseline evaluation, a research assistant randomly assigned each family to one of the 3 groups. Randomization was stratified by the adolescent's sex and by the treatment center. (No statement of concealment of allocation). It is also unclear whether outcomes assessors were blinded. Due to the nature of the intervention, patients could not be blinded. It should be noted that despite randomization the 3 treatment groups differed demographically at baseline. The BFST group included significantly fewer intact families and more single‐parents families than did the other 2 groups
Participants	Inclusion criteria included the following: 12 to 17 years of age, having Type I diabetes for more than 1 year, no other major chronic diseases, no mental retardation, not incarcerated in foster care or in residential psychiatric treatment, no diagnoses of psychosis major depression or substance abuse disorder in adolescents or parents during the previous 6 months. Also, at least 1 family member had to obtain a score on the Diabetes Responsibility and Conflict scale > 24 or a score > 5 on the Conflict Behavior Questionnaire
Interventions	Families were randomized to 3 months of treatment with either Behavioral‐Family Systems Therapy (BFST), an education and support (ES) group, or current therapy (CT). Current Therapy: patients in the CT group (as well as those in the other groups) received standard diabetes therapy from pediatric endocrinologists, including an examination by a physician and a GHb assay at least quarterly; 2 or more daily injection of mixed intermediate‐ and short‐acting insulins; self monitoring of blood glucose and recording of test results; diabetes self management training; a prescribed diet; physical exercise and an annual evaluation for diabetic complications. Education and Support: in the first 3 months of the study, families attended 10 groups meetings that provided diabetes education and social support. A social worker at 1 center and a health educator at another center served as group facilitators. Panels of 2 to 5 families began and completed 10 sessions together; the parents and the adolescent with the diabetes attended the sessions. Family communication and conflict resolution skills were specifically excluded from session content, because these are the primary targets of BFST. Each session included a 45‐minute educational presentation by a diabetes professional, followed by a 45‐minute interaction among the families about a topic led by the facilitator. A monetary incentive, outlined below, was also provided to patients in this group. BFST: adolescents and caregivers in this group received 10 sessions of BFST. BFST consisted of 4 therapy components that were used in accordance with each family's treatment needs as identified by the project psychologists and was based on study data and family interaction during sessions. The 4 therapy components included problem‐solving training, communication skills training, cognitive restructuring and functional and structural family therapy. A monetary incentive was also provided to patients in this group. Monetary incentive ‐ to maximize completion of data collection, families were paid USD 100 (USD 50 for parent, USD 50 for adolescent) on completion of each evaluation. ES and BFST families could earn another USD 100 if they completed all 10 scheduled intervention sessions
Outcomes	Measurement of compliance: a 14‐item, validated Self‐Care Inventory (SCI) was used to measure diabetes treatment adherence during the preceding 3 months. Higher scores indicate better treatment adherence. Questionnaires were given at baseline, at post‐treatment (3 months) and at 6 and 12 months after treatment ended Measurement of clinical health outcomes: glycated hemoglobin (GHb) assays were conducted using affinity chromatography to index recent glycemic control. General parent‐adolescent relationships were assessed via the Parent‐Adolescent Relationship Questionnaire (PARQ), and Type I diabetes‐specific psychological adjustment was assessed via the Teen Adjustment to Diabetes Scale (TADS). Questionnaires were given at baseline, at post‐treatment (3 months) and at 6 and 12 months after treatment ended
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization was not described in detail. "At the end of the baseline evaluation, a research assistant randomly assigned each family to one of the three conditions described below." (pg 442)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) SELF CARE INVENTORY (SCI) ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) TEEN ADJUSTMENT TO DIABETES SCALE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF CARE INVENTORY (SCI) ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) TEEN ADJUSTMENT TO DIABETES SCALE ‐ This is a subjective measure; there is no information on blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF CARE INVENTORY (SCI) ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) TEEN ADJUSTMENT TO DIABETES SCALE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) SELF CARE INVENTORY (SCI) ‐ QUESTIONNAIRE ‐ The distribution of missing data across groups was not given. Insufficient reporting of attrition/exclusions to permit judgment of 'Low risk' or 'High risk' (e.g. number randomized not stated, no reasons for missing data provided)
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) TEEN ADJUSTMENT TO DIABETES SCALE ‐ The distribution of missing data across groups was not given. Insufficient reporting of attrition/exclusions to permit judgment of 'Low risk' or 'High risk' (e.g. number randomized not stated, no reasons for missing data provided)