Supporting Treatment Adherence Needs in Diabetes

NCT01030471 | Withdrawn DMC

• 2 other identifiers: DK81711R03DK081711
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

adolescents; depression; adherence; family functioning; intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Hemoglobin A1c value

  Obtained at 0, 3, and 6 months after enrollment

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Behavioral: Family-based cognitive-behavioral treatment

Wait list control group

NO INTERVENTION

Interventions

Family-based cognitive-behavioral treatment BEHAVIORAL

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.

Lifestyle counseling

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Korey K Hood, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 14, 2020

Record last verified: 2011-06

Locations

US (1)