Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

NCT ID: NCT05915975

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Behavioral Care Coordinated with Medical Care

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.

Group Type EXPERIMENTAL

Behavioral Care Coordinated with Medical Care Intervention

Intervention Type BEHAVIORAL

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.

Behavioral Care Not Coordinated with Medical Care

Participants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance.

Group Type ACTIVE_COMPARATOR

Behavioral Care Not Coordinated with Medical Care Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Behavioral 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.

Intervention Type BEHAVIORAL

Behavioral 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Luiza Vianna Mali

Assistant Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luiza V Mali, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Univeristy of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20230308

Identifier Type: -

Identifier Source: org_study_id

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