Supporting Treatment Adherence Needs in Diabetes (STAND)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Recruiting
Sponsor:
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
  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 April 16, 2014