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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Recruitment Status : Withdrawn (poor accrual)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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Family-based cognitive-behavioral treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supporting Treatment Adherence Needs in Diabetes: The STAND Study
Actual Study Start Date : September 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms [ Time Frame: Assessed at 0, 1.5, 3, and 6 months after enrollment ]
  2. 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 ]

Secondary Outcome Measures :
  1. Hemoglobin A1c value [ Time Frame: Obtained at 0, 3, and 6 months after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030471


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Korey K Hood, PhD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01030471    
Other Study ID Numbers: DK81711
R03DK081711 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: June 2011
Keywords provided by Children's Hospital Medical Center, Cincinnati:
adolescents
depression
adherence
family functioning
intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases