Behavioral Health Intervention for Developmental Disabilities

(BEST Trial)

Overseen By Kristin L Berg, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Severe ID, Low reading level, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new mental health program can help young people with developmental disabilities feel healthier and more prepared for the future. It compares two approaches: regular care coordination services and those same services with added mental health support, including the Adapted Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT). The focus is on reducing anxiety and depression, improving overall well-being, and ensuring participants and their families are satisfied with the care they receive. The trial seeks youth aged 13 to 20 with intellectual or developmental disabilities who already receive care coordination services in Illinois. Participants will be randomly assigned to one of the two groups and monitored over two years, with some receiving direct support for mental health issues like depression and anxiety. As an unphased trial, this study offers participants the chance to contribute to innovative mental health solutions tailored for young people with developmental disabilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on care coordination and mental health support rather than medication changes.

What prior data suggests that this care coordination program is safe for youth with disabilities?

Research shows that the treatments tested in this study are generally safe for people. Here's what is known:

1. **Adapted Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT):** This online program aids young people with intellectual and developmental disabilities (I/DD) in transitioning to adulthood. Although specific safety data for this program is unavailable, similar online cognitive behavioral programs are usually well-tolerated, meaning participants generally handle them well without serious side effects.

2. **Adapted Coping with Depression-Adolescent:** This includes educational sessions to help families understand depression. Research indicates that similar programs are effective for teens and have not shown any major safety concerns. They aim to improve communication and coping skills, which are safe ways to manage depression.

3. **Adapted Teens Achieving Mastery over Stress (TEAMS):** This program teaches teens how to handle stress. Studies show that similar group programs are safe and help reduce stress. The TEAMS program is specifically adapted for youth with I/DD and is offered in a structured and supportive setting.

4. **Maternal Child Health Bureau (MCHB) Care Coordination:** This well-established program helps young people access the health and social services they need. It is widely used and has been shown to improve health outcomes without safety issues.

While specific safety data for each treatment in this study is lacking, these programs are based on methods previously tested. They are designed to be safe and beneficial for youth with disabilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for developmental disabilities because they offer a comprehensive, multi-tiered approach to mental health support. Unlike traditional treatments that primarily focus on symptom management, this intervention combines cognitive-behavioral and interpersonal training with personalized care coordination. The CHECK program is unique as it uses an evidence-based treatment algorithm to classify risk levels for depression and anxiety, guiding tailored interventions from psycho-education to individualized therapy. This structured coordination between health care teams ensures better communication and data sharing, potentially leading to improved outcomes for young individuals with developmental disabilities.

What evidence suggests that this trial's treatments could be effective for youth with developmental disabilities?

This trial will compare Illinois MCHB Care Coordination alone with Illinois MCHB Care Coordination combined with the CHECK program. Studies have shown that the CHECK program, which integrates mental health treatment with care coordination, can assist young people with disabilities by directly addressing depression and anxiety. Research indicates that the CATCH-IT program, a component of CHECK, uses online therapy to help teens transition to adulthood, potentially reducing depression symptoms. The Adapted Coping with Depression-Adolescent and TEAMS programs teach teens to manage stress and negative emotions, showing promise in enhancing mood and coping skills. The well-established MCHB care coordination connects young people to essential health and social resources, supporting their overall well-being. Together, these programs aim to help youth feel healthier and more capable of handling challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Kristin L Berg, PhD

Principal Investigator

University of Illinois at Chicago

Benjamin W Van Voorhees, MD, MPH

Principal Investigator

University of Illinois at Chicago

Iulia Mihaila, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MCHB care coordination alone or MCHB care coordination plus CHECK program, which includes mental health treatment for depression and anxiety.

24 months

Regular check-ins and assessments at baseline, 6, 12, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Illinois MCHB Care Coordination + CHECK tiered behavioral health Experimental Treatment 6 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 Coordination Active Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Wellesley College

Collaborator

Trials

6

Recruited

3,100+

The Arc of Illinois

Collaborator

Trials

1

Recruited

780+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The COPE program is an evidence-based cognitive-behavioral therapy designed for depressed and anxious teens, delivered in brief 30-minute outpatient visits, making it suitable for busy clinical settings.

This program allows advanced practice nurses to effectively utilize their skills to provide timely mental health support to adolescents, enhancing their ability to address common mental health issues in various environments like psychiatric and primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPE for depressed and anxious teens: a brief cognitive-behavioral skills building intervention to increase access to timely, evidence-based treatment. Lusk, P., Melnyk, BM.[2021]

Citations

1. researchgate.net researchgate.net/figure/Abbrevations-CATCH-IT-Competent-Adulthood-Transition-with-Cognitive-Behavioral_fig1_328777984

Abbrevations: CATCH-IT, Competent Adulthood Transition ... This paper describes a comparative effectiveness trial evaluating the efficacy of two evidence-based cognitive-behavioral prevention (CBP) programs: Teens ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834311002507

Adolescent and parent experiences with a primary care/ ... Our intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), is based on face-to-face ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6286074/

Effect of Internet-Based Cognitive Behavioral Humanistic and ... CATCH-IT indicates competent adulthood transition with cognitive behavioral humanistic and interpersonal training; CES-D10, Center for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05520983?term=Best%20Pharmaceuticals%20for%20Children%20Act&viewType=Table&rank=6

BEhavioral Health Stratified Treatment (BEST) Study for ... Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) has been adapted for youth with I/DD. CATCH-IT is an internet-based ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923135/

PATHway: Intervention optimization of a prevention program ... National Institute of Mental Health. CATCH-IT. Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy. MOST. Multiphase ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10839524/

Internet-based cognitive behavioral therapy intervention for ... This study aims to assess the efficacy of Competent Adulthood Transition with Cognitive Humanistic and Interpersonal Teaching (CATCH-IT), an internet-based ...

7. mdpi.com mdpi.com/1660-4601/17/21/7736

Randomized Clinical Trial of an Internet-Based Adolescent ... Our study examines the effects of CATCH-IT compared to online health education (HE) on internalizing symptoms in adolescents at risk for depression.

8. withpower.com withpower.com/trial/phase-depression-8-2022-52719

Behavioral Health Intervention for Developmental Disabilities ... Is the behavioral health intervention for developmental disabilities safe for humans? The research articles provided do not contain specific safety data for the ...