- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030471
Supporting Treatment Adherence Needs in Diabetes (STAND)
September 10, 2020 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle counseling
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms
Time Frame: Assessed at 0, 1.5, 3, and 6 months after enrollment
|
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
|
Assessed at 0, 1.5, 3, and 6 months from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin A1c value
Time Frame: Obtained at 0, 3, and 6 months after enrollment
|
Obtained at 0, 3, and 6 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Korey K Hood, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2009
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
December 10, 2009
First Submitted That Met QC Criteria
December 10, 2009
First Posted (Estimate)
December 11, 2009
Study Record Updates
Last Update Posted (Actual)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 10, 2020
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK81711
- R03DK081711 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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