Supporting Treatment Adherence Needs in Diabetes (STAND)
This study is currently recruiting participants.
Verified June 2011 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01030471
First received: December 10, 2009
Last updated: June 21, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Behavioral: Family-based cognitive-behavioral treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Supporting Treatment Adherence Needs in Diabetes: The STAND Study |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Medical Center, Cincinnati:
Primary Outcome Measures:
- Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms [ Time Frame: Assessed at 0, 1.5, 3, and 6 months after enrollment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hemoglobin A1c value [ Time Frame: Obtained at 0, 3, and 6 months after enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 52 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lifestyle counseling |
Behavioral: Family-based cognitive-behavioral treatment
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.
|
| No Intervention: Wait list control group |
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030471
Contacts
| Contact: Korey K Hood, PhD | (513) 803-0405 | korey.hood@cchmc.org |
Locations
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Korey K Hood, PhD 513-803-0405 korey.hood@cchmc.org | |
| Sub-Investigator: Lawrence Dolan, MD | |
| Principal Investigator: Korey K Hood, PhD | |
| Sub-Investigator: Richard Ittenbach, PhD | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
| Principal Investigator: | Korey K Hood, PhD | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | Korey K. Hood, PhD/Assistant Professor of Pediatrics, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT01030471 History of Changes |
| Other Study ID Numbers: | DK81711, R03DK081711 |
| Study First Received: | December 10, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
adolescents depression adherence family functioning intervention |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013