Ellis 2012.

Methods	Randomized controlled trial
Participants	The study location was Children's Hospital of Michigan, Detroit, Michigan, USA 74 participants were randomized to the intervention group and 72 participants were randomized to the control group The inclusion criteria were between 10 and 18 years old with type 1 or 2 diabetes for at least 1 year that required management with insulin, a current HbA1c of 8% or higher, a mean HbA1c of 8% or higher during the year before the study entry, and residing in a home setting The exclusion criteria were moderate or severe mental retardation, psychosis, not English speaking, or unable to complete study measures in English
Interventions	Intervention: MULTISYSTEMIC THERAPY Patients in the MST group received both standard medical care and treatment sessions by 5 masters‐level therapists trained to have sufficient knowledge regarding diabetes to enable them to conduct diabetes adherence interventions with families. Treatment included 1‐hour family treatment sessions, skills practice (e.g. spending 15 minutes in home to observe a caregiver implementing a reward or consequence as part of a behavior plan), attending school meetings to provide information to staff regarding diabetes care (e.g. 1 to 2‐hour staff training), and attending clinic visits with families (2 hours or more) Control: TELEPHONE SUPPORT Control patients (telephone support) received an initial home visit where the program was explained to the adolescent and primary caregiver by either a master level therapists or doctoral students in clinical psychology or social work. Weekly phone calls (approximately 30 minutes each) focused on emotional support for diabetes care using client‐centered, nondirective counseling, assessing adherence to diabetes for the previous week, reviewing readings in the blood glucose meter, and helping the adolescent identify solutions to any barriers in their diabetes care. Non‐diabetes‐related problems such as peer, school, or family relationship problems were also addressed during the call if desired by the adolescent. Telephone support therapists completed the same formal diabetes education training completed by MST therapists
Outcomes	The measures of adherence were parent‐reported adherence and patient‐reported adherence using the Diabetes Management Scale, a questionnaire that measures a broad range of diabetes management behaviors (insulin, diet, blood glucose, symptom response). The questionnaires were administered to parents and patients by a trained research assistant in the participants' homes at baseline and at 7 and 12 months (6‐month follow‐up) The patient outcome was hemoglobin A1c (HbA1c), as measured by a pediatric endocrinologist every 3 to 4 months
Notes	ClinicalTrials protocol found
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	(pg 208) Minimization used: "Randomization... using a permuted block algorithm to ensure equivalence across treatment condition. The project statistician generated the randomization sequence..."
Allocation concealment (selection bias)	Low risk	The project statistician generated the randomization sequence ‐ randomization controlled by independent administration group
Selective reporting (reporting bias)	High risk	They do not report on diabetic ketoacidosis (DKA) admissions and emergency room (ER) visits as noted in NCT00372814
Other bias	Unclear risk	Limitations: Adherence measures: self report and by primary caregiver not always present to verify adherence. Intervention (MST) had more contacts per week than control (telephone): 2 to 3/week compared with 1/week. "In addition, the follow‐up period in the current study was limited to 6 months after the conclusion of treatment. While still significant, reductions in average blood glucose levels were attenuated at 6 months follow‐up. Longer‐term follow‐up is needed to better assess the sustainability of MST effects over time. MST and telephone support were not matched on dose (e.g., two to three contacts per week versus one contact per week). Therefore, the possibility that a higher intervention dose in the MST condition accounted for better health outcomes for youth receiving MST cannot be ruled out."
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORTED QUESTIONNAIRE ‐ (pg 209) "All measures were collected by a trained research assistant in the participants' homes. The research assistant was blind to treatment assignment to the extent possible in a behavioral trial"
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) HBA1C ‐ Blinding not mentioned but this an objective measure
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORTED QUESTIONNAIRE ‐ Participant (primary caregiver/parent) blinding not mentioned and likely to affect outcome
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) HBA1C ‐ Blinding not mentioned but this an objective measure
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SELF REPORTED QUESTIONNAIRE ‐ The study does not mention blinding of other personnel but unlikely to affect outcome; intervention and control involved different study personnel
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) HBA1C ‐ Blinding not mentioned but this an objective measure
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORTED QUESTIONNAIRE ‐ Low rate of missing data, reasons not related to outcome, ITT analysis used
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) HBA1C ‐ Low rate of missing data, reasons not related to outcome, ITT analysis used