Behavioral Health Intervention for Developmental Disabilities
(BEST Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin W Van Voorhees, MD, MPH

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Illinois at Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

Many youth with disabilities and their families receive "care coordination services" from a state Maternal and Child Health Bureau (MCHB) agency. MCHB care coordination services help youth with disabilities get the medical care and social services they need to be healthy. Complex HEalth Care for Kids (CHECK) developed a program to combine mental health treatment and care coordination services for youth with disabilities. The goal of this study is to see whether a care coordination program that treats depression and anxiety (MCHB care coordination + CHECK) is better than a care coordination program (MCHB care coordination alone) that refers youth to mental health services in terms of making youth feel healthier, happier, and able to handle future challenges. The project team will test which care coordination approach is better at making youth with disabilities: (Aim 1) less anxious and depressed; (Aim 2) feel healthier, function better, and practice healthy habits; (Aim 3) improve their ability to manage their health. This study will also evaluate which approach makes (Aim 4) youth, caregivers, and providers feel more satisfied with their care coordination experience. This study will give youth with disabilities and their families information about what kinds of care coordination models are available, and better suited to their needs. The study team will reach out to 780 youth with intellectual and/or developmental disabilities, age 13-20 years old, who receive care coordination services from the state of Illinois MCHB. If these youth are eligible and agree to be in the study, they will be placed, by chance, into either MCHB care coordination alone or into the MCHB care coordination + CHECK program. In both groups, youth will have a care coordinator who helps them identify and make plans to meet their needs and provides referrals to services/resources. Youth in the MCHB care coordination + CHECK care coordination will get mental health treatment directly from CHECK staff if they report symptoms of depression or anxiety. Treatment may include an online program or group meetings that teach youth how to cope with negative thoughts and feelings. Youth in each group will be followed for 24 months and will receive gift cards for participating. Youth will be asked questions about anxiety and depression, health, functioning, ability to manage their health care, self-efficacy, and their experience with care coordination.

Research Team

Kristin L Berg, PhD

Principal Investigator

University of Illinois at Chicago

Iulia Mihaila, PhD

Principal Investigator

University of Illinois at Chicago

Benjamin W Van Voorhees, MD, MPH

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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.

Inclusion Criteria

I am between 13 and 20 years old with an intellectual or developmental disability, receiving care through IL DSCC.

Exclusion Criteria

I am unable to give consent for the study as per the MacCAT-CR assessment.

Participant has a reading/comprehension level below 4th grade (caregiver/self-report)

I have a severe intellectual disability (IQ below 50).

Treatment Details

Interventions

Adapted Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) (Behavioural Intervention)
Adapted Coping with Depression-Adolescent (Behavioural Intervention)
Adapted Teens Achieving Mastery over Stress (TEAMS) (Behavioural Intervention)
Adapted Teens Achieving Mastery over Stress (TEAMS) Prevention (Behavioural Intervention)
Adapted Teens Achieving Mastery over Stress (TEAMS) Treatment (Behavioural Intervention)
Maternal Child Health Bureau (MCHB) Care Coordination (Other)
Strengthening Families (Behavioural Intervention)
Virtual psycho-educational discussion groups for caregivers and participants (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.