Supporting Treatment Adherence Needs in Diabetes

Not Applicable

Withdrawn

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Family-based cognitive-behavioral treatment

• Registration Number: NCT01030471
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Status Verified: 2011-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Family-based cognitive-behavioral treatment	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hemoglobin A1c value	Obtained at 0, 3, and 6 months after enrollment

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States