Supporting Treatment Adherence Needs in Diabetes

Type 1 Diabetes Clinical Trial

— STAND  

Official title:

Supporting Treatment Adherence Needs in Diabetes: The STAND Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01030471
• Other study ID #: DK81711
• Secondary ID: R03DK081711
• Status: Withdrawn
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: June 2011
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Inventory (CDI)-Measure of adolescent depressive symptoms		Assessed at 0, 1.5, 3, and 6 months after enrollment
Primary	Diabetes-Related Family Conflict Scale (DFCS)-Measure of family conflict around diabetes-specific tasks		Assessed at 0, 1.5, 3, and 6 months from enrollment
Secondary	Hemoglobin A1c value		Obtained at 0, 3, and 6 months after enrollment