| Methods |
Following completion of this baseline assessment, adolescents (n = 53) were randomly assigned to either the standard care condition (n = 26) or the multisystemic therapy (MST) plus standard care condition (n = 27). The data collection staff worked independently from the MST intervention staff, and were blind to treatment conditions for the subjects |
| Participants |
Participating adolescents had: a) a diagnosis of type 1 diabetes for a minimum of 1 year; b) glycosylated hemoglobin (HbA1c) of at least 8% at the onset of the study; c) an average HbA1c of at least 8% for the previous year. Adolescents were excluded from the study if they: a) were unable to speak English; b) had been diagnosed with a thought disorder, such as schizophrenia; or c) suffered from an additional chronic illness that may interfere with conventional treatment for type 1 diabetes |
| Interventions |
Standard care consisted of receiving treatment from a multidisciplinary team. Adolescents and their families attended clinic appointments every 3 months to monitor the adolescent's health and were provided with traditional diabetes education services and eligible to be referred to community‐based mental health agencies for psychological or adherence concerns. In addition to the standard diabetes care described above, adolescents and their families assigned to the MST intervention received approximately 7 months of this family‐based treatment. The initial goals of treatment were to understand and form hypotheses as to what factors are maintaining the adolescent's poor health status. Interventions were then implemented to address these problematic areas, including problems with general and diabetes‐specific family interaction patterns negatively impacting the adolescent's treatment adherence. Overarching goals of MST interventions often included increasing family cohesion and structure, as they relate to completing diabetes management tasks. A variety of behaviorally‐based, action‐oriented interventions may have been used during MST including parent management training, problem‐solving skills training, and contingency management. Specifically, family‐based interventions are designed to improve communication between family members regarding completion of adherence tasks, ensure adequate parental supervision of diabetes management behaviors, and provide family members with strategies to address general and diabetes‐specific conflict situations. Overall, the goal of MST is to encourage parents to adopt an authoritative parenting style in which they are responsive to their adolescent's health needs, able to see clearly defined expectations for adherence behaviors, and able to enforce effective discipline strategies to address problematic behavior. Treatment was terminated when overarching goals were accomplished |
| Outcomes |
Compliance was measured using the 1) Diabetes Management Scale (DMS) and 2) 24‐Hour Recall Interview. Both were administered separately to the adolescent and parent. Glycosylated hemoglobin (HbA1c) values were used as clinical endpoints |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail |
| 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 |
High risk |
Follow‐up data were collected immediately following the completion ‐ or at the end ‐ of treatment for families receiving MST intervention |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) DIABETES MANAGEMENT SCALE ‐ Personnel were blinded to treatment conditions |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C ‐ Objective measure, unlikely to be biased. The staff were blinded |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) DIABETES MANAGEMENT SCALE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) DIABETES MANAGEMENT SCALE ‐ 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 |
Low risk |
(PRIMARY) HBA1C ‐ Objective measure, unlikely to be biased |
| Incomplete outcome data (attrition bias)
Adherence measure |
High risk |
(PRIMARY) DIABETES MANAGEMENT SCALE ‐ There are more than 20% dropouts. Unable to determine whether the reason for 7 families that dropped is related to the outcome. Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HBA1C ‐ There are more than 20% dropouts. Unable to determine whether the reason for 7 families that dropped is related to the outcome. Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups |
