| Methods |
Randomization was completed immediately after baseline data collection by the project statistician. To ensure equivalence across treatment condition, randomization was stratified by level of glycosylated hemoglobin levels (HbA1c) at the baseline visit. A total of 127 adolescents and their families were randomized to either receive the multisystemic therapy (MST) (intervention group) (n = 64) or to the control group (n = 63) |
| Participants |
Patients were 1) diagnosed with type 1 diabetes for at least 1 year; 2) had an average HbA1c (A1C) > or = to 8% during the year before study entry, as well as a most recent A1C > or = to 8%; 3) aged 10 to 17 years, and 4) sufficient mastery of English to communicate with therapists and complete study measures. Patients were excluded from the study if they possessed moderate/severe mental retardation or psychosis |
| Interventions |
Adolescents assigned to the intervention condition received multisystemic therapy (MST) plus standard medical care. MST is an intensive, family‐centered, community‐based treatment. Therapists conducted a multisystemic assessment of the strengths and weaknesses of the family, then tailored treatment goals and interventions to each family to best treat the adherence problem. MST interventions targeted adherence‐related problems within the family system, peer network, and the broader community systems within which the family was embedded. The therapists drew upon evidence‐based intervention techniques that included cognitive behavioral therapy, parent training, and behavioral family systems therapy; the various interventions were incorporated at home, school, with peers, and within the healthcare system. Therapists were expected to meet with families a minimum of 2 to 3 times per week at the beginning of treatment. Treatment was terminated when treatment goals were met and the mean length of treatment in the study was 5.7 months. Adolescents in the control condition received standard medical care. Standard care at the hospital where adolescents were cared for consisted of quarterly medical visits with a multidisciplinary medical team composed of an endocrinologist, nurse, dietitian, social worker, and psychologist |
| Outcomes |
Patients completed the 24‐Hour Recall Interview to assess adherence behaviors for the previous day
Clinical outcomes included HbA1c values, number of ER visits, and number of hospitalizations |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not enough information about randomization process. (pg 1605) "Randomization to the treatment condition was completed immediately after baseline data collection by the project statistician" |
| Allocation concealment (selection bias) |
Unclear risk |
Method of allocation concealment not described |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
No other apparent bias but insufficient information provided |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) 24‐HOUR RECALL INTERVIEW ‐ No blinding measure described. Not clear who collected the data |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) A1C ‐ Outcome less likely to be influenced by lack of blinding. No blinding measures described in the text |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) 24‐HOUR RECALL INTERVIEW ‐ No evidence of blinding, subjective outcome |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) A1C ‐ Outcome less likely to be influenced by lack of blinding. No blinding measures described in the text |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) 24‐HOUR RECALL INTERVIEW ‐ No blinding measure described |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) A1C ‐ Outcome less likely to be influenced by lack of blinding. No blinding measures described in the text |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) 24‐HOUR RECALL INTERVIEW ‐ 6 (9%) of intervention group used insulin pumps ‐ they were not evaluated for insulin adherence; 4 of the same group did not receive intervention. Not known whether this had an effect. Also "Data were collected at 7, 12, 18, and 24 months after baseline data collection. The present study reports on data from 7 months posttest, as data collection at later time points is not yet complete." |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) A1C ‐ 6 (9%) of intervention group used insulin pumps ‐ they were not evaluated for insulin adherence; 4 of the same group did not receive intervention. Not known whether this had an effect. Also "Data were collected at 7, 12, 18, and 24 months after baseline data collection. The present study reports on data from 7 months posttest, as data collection at later time points is not yet complete." |
