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Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Care Coordinated with Medical Care Intervention
Behavioral Care Not Coordinated with Medical Care Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 1

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Univeristy of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Care Coordinated with Medical Care

Behavioral Care Not Coordinated with Medical Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Glycemic Control
Will be measured by glycosylated hemoglobin A1c

Secondary Outcome Measures

Change in Diabetes Self-Management
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).

Full Information

First Posted
June 14, 2023
Last Updated
October 18, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05915975
Brief Title
Integrated Behavioral Healthcare for Youth With Type 1 Diabetes
Official Title
Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Care Coordinated with Medical Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral Care Not Coordinated with Medical Care
Arm Type
Active Comparator
Arm Description
Participants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Care Coordinated with Medical Care Intervention
Intervention Description
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
Intervention Name(s)
Behavioral Care Not Coordinated with Medical Care Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glycemic Control
Description
Will be measured by glycosylated hemoglobin A1c
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Change in Diabetes Self-Management
Description
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).
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiza V Mali, Ph.D.
Phone
(305)243-6882
Email
lvm852@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiza V Mali, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiza V Mali, Ph.D.
Phone
305-243-6882
Email
lvm852@miami.edu
First Name & Middle Initial & Last Name & Degree
Luiza V Mali, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

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