Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supporting Treatment Adherence Needs in Diabetes (STAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01030471
Recruitment Status : Withdrawn (poor accrual)
First Posted : December 11, 2009
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE December 11, 2009
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
  • Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms [ Time Frame: 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 [ Time Frame: Assessed at 0, 1.5, 3, and 6 months from enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
Hemoglobin A1c value [ Time Frame: Obtained at 0, 3, and 6 months after enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supporting Treatment Adherence Needs in Diabetes
Official Title  ICMJE Supporting Treatment Adherence Needs in Diabetes: The STAND Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Lifestyle counseling
    Intervention: Behavioral: Family-based cognitive-behavioral treatment
  • No Intervention: Wait list control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 9, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2009)
52
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01030471
Other Study ID Numbers  ICMJE DK81711
R03DK081711 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Korey K Hood, PhD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date June 2011

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