Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Study Overview
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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).

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Behavioral Care Coordinated with Medical Care Intervention
* Behavioral: Behavioral Care Not Coordinated with Medical Care Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Care Coordinated with Medical Care<br>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<br>* 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.<br>|
| Active Comparator: Behavioral Care Not Coordinated with Medical Care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic Control | Will be measured by glycosylated hemoglobin A1c | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 4 months |