Supporting Treatment Adherence Needs in Diabetes: The STAND Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Lifestyle counseling
Intervention: Family-based cognitive-behavioral treatment (Behavioral)
Wait list control group
Outcomes
Primary Outcomes
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
Time Frame: 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
Time Frame: Assessed at 0, 1.5, 3, and 6 months from enrollment
Secondary Outcomes
- Hemoglobin A1c value(Obtained at 0, 3, and 6 months after enrollment)