Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Behavioral Care Coordinated with Medical Care Intervention; Behavioral: Behavioral Care Not Coordinated with Medical Care Intervention

• Registration Number: NCT05915975
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2023-11-07
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Type 1 Diabetes diagnosed for one year or more
2. Latino or Black ethnicity/race
3. Speak and read English or Spanish
4. Eligibility for Medicaid

Exclusion Criteria

1. Significant developmental disability
2. Serious psychiatric disorder
3. Another serious chronic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Care Coordinated with Medical Care	Behavioral Care Coordinated with Medical Care Intervention	Participants in this group will work with a study team member for four months to improve your skills to manage diabetes, to strengthen the child-caregiver relationship, and/or to address emotional challenges that your child might be experiencing.
Behavioral Care Not Coordinated with Medical Care	Behavioral Care Not Coordinated with Medical Care Intervention	Participants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance.

Primary Outcome Measures

Name	Time	Method
Change in Glycemic Control	Baseline and 4 months	Will be measured by glycosylated hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Self-Management	Baseline and 4 months	We will measure Type 1 Diabetes Self-management using the Diabetes Management Questionnaire (DMQ; Score Range: 0-100, higher scores indicate greater adherence to diabetes management).

Trial Locations

Locations (1)

Univeristy of Miami; 🇺🇸 Miami, Florida, United States