Integrated Behavioral Healthcare for Youth With Type 1 Diabetes
1 other identifier
interventional
9
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 9, 2024
October 1, 2024
11 months
June 14, 2023
October 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycemic Control
Will be measured by glycosylated hemoglobin A1c
Baseline and 4 months
Secondary Outcomes (1)
Change in Diabetes Self-Management
Baseline and 4 months
Study Arms (2)
Behavioral Care Coordinated with Medical Care
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance.
Interventions
Participants will be meeting with a behavioral health provider during their clinic visit. Subsequent visits can be held either via telehealth or in-person. Participants should expect weekly visits during the first two months and less frequent visits (biweekly or monthly) for the last two months. Some sessions that are provided via telehealth might be video recorded and later reviewed to ensure that the program is being delivered as intended.
Participants will meet with a study team member during their in-person visit and will receive a list of clinics that are panelled with their insurance. The participants will be responsible for calling the clinics to set up their appointments. Services might be provided in person or via telehealth based on the participant's preference and the clinics' availability.
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes diagnosed for one year or more
- Latino or Black ethnicity/race
- Speak and read English or Spanish
- Eligibility for Medicaid
You may not qualify if:
- Significant developmental disability
- Serious psychiatric disorder
- Another serious chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiza V Mali, Ph.D.
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Pediatrics
Study Record Dates
First Submitted
June 14, 2023
First Posted
June 23, 2023
Study Start
November 7, 2023
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share