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

780 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for Behavioral Health Intervention for Developmental Disabilities?

The research suggests that interventions focusing on coping strategies, such as secondary control coping (adapting to stress), are effective in helping children and adolescents manage chronic illnesses. This aligns with the components of the CATCH-IT and TEAMS programs, which aim to improve coping and stress management skills. ^{1 2 3 4 5}

Is the behavioral health intervention for developmental disabilities safe for humans?

The research articles provided do not contain specific safety data for the behavioral health intervention for developmental disabilities or its adaptations. However, cognitive-behavioral therapy (CBT), a related approach, is generally considered safe and has been widely used in various mental health treatments. ^{6 7 8 9 10}

How is the CATCH-IT treatment for developmental disabilities different from other treatments?

The CATCH-IT treatment is unique because it integrates cognitive-behavioral and interpersonal training into an Internet-based program, making it accessible and cost-effective for adolescents. It focuses on preventing depression by fitting within a broader health system context, unlike traditional treatments that may not be as easily accessible or integrated into primary care. ^{11 12 13 14 15}

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).

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychologists and the Transition From Pediatrics to Adult Health Care. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Transition of cognitively delayed adolescent organ transplant recipients to adult care. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Coping with chronic illness in childhood and adolescence. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Transition of care in adolescents with chronic disease: A concept analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Transition Consultation Models in Two Academic Medical Centers. [2018]

6. England 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. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of Youth Flexible Assertive Community Treatment: outcomes of an 18-month observational study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Implementation of the Wolverine Mental Health Program, Part 2: Implementation Phase. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Young Patients With Persistent and Complex Care Needs Require an Integrated Care Approach: Baseline Findings From the Multicenter Youth Flexible ACT Study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy studies to large-scale transport: the development and validation of multisystemic therapy programs. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Integrated Behavioral Health Care in Pediatric Subspecialty Clinics. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Pilot Study of Implementation of an Internet-Based Depression Prevention Intervention (CATCH-IT) for Adolescents in 12 US Primary Care Practices: Clinical and Management/Organizational Behavioral Perspectives. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

BEhavioral Health Stratified Treatment (B.E.S.T.) to optimize transition to adulthood for youth with intellectual and/or developmental disabilities. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a technology-based behavioral vaccine to prevent adolescent depression: A health system integration model. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Support for Transition from Adolescent to Adult Health Care Among Adolescents With and Without Mental, Behavioral, and Developmental Disorders - United States, 2016-2017. [2022]