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Behavioral Health Intervention for Developmental Disabilities (BEST Trial)

N/A

Waitlist Available

Led By Kristin L Berg, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combined mental health treatment and care coordination program for youth with disabilities to see if it helps them cope better with anxiety, depression, and manage their health better. 780 youth in Illinois will be randomly placed in either the combined program or care coordination alone.

Who is the study for?

This trial is for young people aged 13-20 with intellectual and/or developmental disabilities (IDD) who are enrolled in MCHB care in Illinois. They must be able to consent to the study and have at least a 4th-grade reading level. Those with severe intellectual disability (IQ <50) or very low comprehension skills are not eligible.

What is being tested?

The BEST Study tests if adding mental health treatment to MCHB care coordination helps youth with IDD feel less anxious and depressed, healthier, function better, practice healthy habits, and manage their health more effectively compared to standard MCHB care coordination.

What are the potential side effects?

Since this trial involves behavioral interventions like online programs and group meetings rather than medication, traditional side effects aren't expected. However, discussing sensitive topics could potentially cause temporary discomfort or emotional distress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 24 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

Anxiety Symptomatology

Anxiety Symptomatology of Caregiver

Depressive Symptomatology

+3 more

Secondary study objectives

Adverse Childhood Experiences

Caregiver-Reported Adaptive Functioning

Cognitive Style

+17 more

Other study objectives

Sociodemographic Information

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: Illinois MCHB Care Coordination + CHECK tiered behavioral healthExperimental Treatment6 Interventions

MCHB Care Coordination plus CHECK: includes all elements of MCHB care coordination, described above, plus the CHECK program. The CHECK program consists of a trained, behavioral health care team; an evidence-based treatment algorithm to classify risk for depression and anxiety (minimal, subclinical and clinical symptomatology) and guide treatment advancement \[Tier 1/selective: cognitive behavioral psycho-education; Tier 2/indicated: cognitive-behavioral prevention groups; Tier 3/treatment: individualized or group cognitive-behavioral treatment (CBT)\]; as well as structures and processes to support communication, coordination and data sharing between MCHB care coordinators and CHECK staff.

Group II: Illinois MCHB Care CoordinationActive Control1 Intervention

MCHB Care Coordination is funded through the Social Security Act of 1935 Title V Maternal and Child Health Services Block Grant Program, this is the oldest and most universal care coordination model for children with I/DD. The University of Illinois Chicago Division of Specialized Care for Children (DSCC) is the Illinois (IL) state Title V MCHB care coordination agency and has annual contact with over 19,000 families and youth in IL. MCHB (known as DSCC) Care Coordination involves: comprehensive needs assessments, person-centered planning, and linkage to health care and social resources. MCHB care coordination has established efficacy, feasibility, and acceptability in improving child and family functioning, youth health, and health care access.

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