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Supporting Treatment Adherence Needs in Diabetes (STAND)

This study is currently recruiting participants.
Verified June 2011 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes

December 10, 2009
June 21, 2011
September 2009
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01030471 on ClinicalTrials.gov Archive Site
Hemoglobin A1c value [ Time Frame: Obtained at 0, 3, and 6 months after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Supporting Treatment Adherence Needs in Diabetes
Supporting Treatment Adherence Needs in Diabetes: The STAND Study

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes
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.
  • Experimental: Lifestyle counseling
    Intervention: Behavioral: Family-based cognitive-behavioral treatment
  • No Intervention: Wait list control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
13 Years to 17 Years
No
Contact: Korey K Hood, PhD (513) 803-0405 korey.hood@cchmc.org
United States
 
NCT01030471
DK81711, R03DK081711
Yes
Korey K. Hood, PhD/Assistant Professor of Pediatrics, Cincinnati Children's Hospital Medical Center
Children's Hospital Medical Center, Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Korey K Hood, PhD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP