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Behavioural Intervention

Coordinated Behavioral Care for Type 1 Diabetes

N/A

Waitlist Available

Led By Luiza V Mali, Ph.D.

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 1 Diabetes diagnosed for one year or more

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how coordinated mental health care affects diabetes care compared to care not connected to diabetes care.

Who is the study for?

This trial is for English or Spanish-speaking youth with Type 1 Diabetes diagnosed for over a year, eligible for Medicaid, and of Latino or Black ethnicity. It's not suitable for those with serious psychiatric disorders, significant developmental disabilities, or other chronic illnesses.

What is being tested?

The study compares two types of care: one where behavioral health care is coordinated with diabetes medical care versus another where it's uncoordinated and provided separately in the community.

What are the potential side effects?

Since this trial focuses on behavioral healthcare methods rather than medication, traditional side effects are not applicable. However, participants may experience varying psychological impacts based on the type of care received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Type 1 Diabetes for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Glycemic Control

Secondary study objectives

Change in Diabetes Self-Management

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Care Coordinated with Medical CareExperimental Treatment1 Intervention

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 II: Behavioral Care Not Coordinated with Medical CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Care Coordinated with Medical Care Intervention

2023

N/A

~10

0 / 1Eligibility criteria met