Supporting Treatment Adherence Needs in Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Supporting Treatment Adherence Needs in Diabetes: The STAND Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Family-based cognitive-behavioral treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Behavioral: Family-based cognitive-behavioral treatment<br>* 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.<br>|
| No Intervention: Wait list control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c value |  | Obtained at 0, 3, and 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, depression, adherence, family functioning, intervention