Type 1 Diabetes
Conditions
Keywords
adolescents, depression, adherence, family functioning, intervention
Brief summary
There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.
Interventions
BEHAVIORALFamily-based cognitive-behavioral treatment
Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-17 * Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year * Daily insulin dosing of at least 0.5 units per kilogram per day * Clinical elevation on the CDI (i.e., score at or above 13) * Assent to participation in study
Exclusion criteria
* Other chronic, physical disease or condition except for celiac or thyroid disease * Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa) * Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's) * Current enrollment in psychotherapy specifically targeting depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms | Assessed at 0, 1.5, 3, and 6 months after enrollment |
| Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks | Assessed at 0, 1.5, 3, and 6 months from enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c value | Obtained at 0, 3, and 6 months after enrollment |
Countries
United States
Outcome results
None listed