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Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05915975
Enrollment
9
Registered
2023-06-23
Start date
2023-11-07
Completion date
2024-09-30
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 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).

Interventions

BEHAVIORALBehavioral Care Coordinated with Medical Care Intervention

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.

BEHAVIORALBehavioral Care Not Coordinated with Medical Care Intervention

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Glycemic ControlBaseline and 4 monthsWill be measured by glycosylated hemoglobin A1c

Secondary

MeasureTime frameDescription
Change in Diabetes Self-ManagementBaseline and 4 monthsWe 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026