Supporting Treatment Adherence Needs in Diabetes (STAND)

Cincinnati Children's Hospital Medical Center

Status: Withdrawn

Conditions: Type 1 Diabetes

Treatments: Behavioral: Family-based cognitive-behavioral treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01030471

DK81711

R03DK081711 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Lifestyle counseling

Experimental group

Treatment:

Behavioral: Family-based cognitive-behavioral treatment

Wait list control group

No Intervention group