Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915975

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Behavioral: Behavioral Care Coordinated with Medical Care Intervention Behavioral: Behavioral Care Not Coordinated with Medical Care Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Change in Glycemic Control [Baseline and 4 months]
Will be measured by glycosylated hemoglobin A1c

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Significant developmental disability
Serious psychiatric disorder
Another serious chronic illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Luiza V Mali, Ph.D., University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luiza Vianna Mali, Assistant Professor of Clinical Pediatrics, University of Miami

ClinicalTrials.gov Identifier:

NCT05915975

Other Study ID Numbers:

20230308

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jun 23, 2023