Clinical trial NCT05520983: BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Official title: BEhavioral Health Stratified Treatment (BEST) to Optimize Transition to Adulthood for Youth With Intellectual and/or Developmental Disabilities (IDD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Anxiety
Transition
Keywords: Youth
Intellectual and developmental disabilities
Care coordination
Transition to adulthood
Cognitive-behavioral therapy
Adolescents
Depression
Anxiety
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Wellesley College
name: The Arc of Illinois
name: University of Chicago
name: University of California, Los Angeles
First posted: 2022-08-30
Enrollment: 780
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative-effectiveness study of two different care coordination models
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Background and Significance : Youth (13-20 years) with intellectual and/or developmental disabilities (I/DD) often struggle with depression and anxiety disorders, which adversely impacts transition to adulthood. Integrated behavioral health care coordination, in which care coordinators and behavioral health specialists work together to provide systematic, cost-effective, patient-centered care, is an effective strategy to improve access to behavioral health services and address factors that impact transition to adulthood, including depression/anxiety symptoms. Current widely used care coordination models, such as Title V Maternal and Child Health Bureau (MCHB) care coordination (operating in \> 40 states), do not include behavioral health services. Coordination of CarE for Complex Kids (CHECK), is a behavioral health risk classification and intervention delivery program that was designed for integration into care coordination programs, such as MCHB care coordination, and implemented under Centers for Medicare and Medicaid (CMS) Healthcare Innovation Award (#C1C1CMS331342-01-00; 2014-2018, $19.4 million, \>6,000 youth enrolled). It is unknown whether an integrated behavioral health care coordination strategy, such as MCHB care coordination plus CHECK, would be more acceptable and lead to better youth health and transition outcomes, in comparison to standard care coordination (e.g., MCHB care coordination). Results would guide future investment in improving outcomes for youth with I/DD.

Aims: This study is a two-arm randomized clinical trial to evaluate the comparable efficacy of (1) MCHB Care Coordination alone vs. (2) MCHB Care Coordination plus CHECK in: (Aim 1) decreasing symptoms and episodes of depression and anxiety over time among at-risk transition-age youth with I/DD; (Aim 2) improving health behaviors, adaptive functioning and health related quality of life among transition-age youth with I/DD; (Aim 3) increasing health care transition (HCT) readiness among transition-age youth with I/DD; and (Aim 4) improving engagement and satisfaction with care coordination among stakeholders across multiple levels.

Comparators: 1. IL MCHB Care Coordination 2. IL MCHB Care Coordination + CHECK

1. MCHB Care Coordination: 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 at Chicago (UIC) 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.
2. MCHB Care Coordination plus CHECK: includes all elements of MCHB care coordination, described above, plus the CHECK program. CHECK 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 \[Tier 1/selective: cognitive behavioral psychoeducation; Tier 2/indicated: cognitive-behavioral prevention groups; Tier 3/treatment: individualized or group cognitive behavioral treatment (CBT)\]; as well as structures and processes to support communication, coordination and data sharing between MCHB care coordinators and CHECK staff. The CHECK Tiers are based upon the Coping with Depression-Youth curriculum and employ a psychoeducational approach to teach youth cognitive behavioral skills to prevent or reduce depression and anxiety symptoms and episodes (Clarke et al; integrative CBT model). The CHECK program was implemented within a large, community-based care coordination system, reached Level 6 integration (Full Collaboration in a Transformed /Merged Integrated Practice), and demonstrated feasibility, acceptability and favorable impacts on health, engagement and other outcomes.

Study Population: The investigators will recruit N=780 (N1=390; N2=390) transition-age youth with I/DD (13-20 years) from the IL MCHB Care Coordination program (i.e., DSCC), which serves a large racially, geographically, and socioeconomically diverse population across IL (23.65% Hispanic/Latino; 20.13% African American; 3.53% Asian; 50.20% White; 0.12% American Indian/Native Alaskan; 0.06% Native Hawaiian/other Pacific Islander) (57.00% male; 40.20% female; 2.70% transgender/non binary). Eligibility criteria include being a current DSCC participant, aged 13-20 years, with a minimum 4th grade reading level, and prior diagnosed I/DD. I/DD are chronic conditions, beginning at birth or prior to age 22 years, and include physical, learning, language, and/or behavioral impairments. Participants must be competent to consent. Exclusion criteria include severe intellectual disability (ID) (i.e., IQ\<50) and reading below a 4th grade level. Assuming 10% loss to follow-up, the investigators require N = 780 for the 2-arm study.

Analytic Plan: The experimental design of the study is a 2 Group (MCHB care coordination vs. MCHB care coordination + CHECK intervention), 4 Times (0 baseline, 6, 12, and 24 months) repeated measures design. The goal is to determine whether the combination of MCHB care coordination plus CHECK yields greater improvement in patient outcomes over time than MCHB care coordination alone. The outcomes are continuous approximately normal multi-item scales (AIM 1: depression/anxiety symptomatology; AIM 2: health behaviors, adaptive functioning and health related quality of life; AIM 3: health care transition readiness; and AIM 4: engagement and satisfaction) which will be analyzed using linear mixed models (LMMs) that are the modern standard for analysis of repeated measures. The generalized linear mixed model (GLMM) will be used to analyze repeated outcomes that are categorical or counts (AIM 1: depression and anxiety episodes). In this design, contrasts can be used to test omnibus and group-specific (interaction) changes from baseline. Our primary model will include covariates for stratification variables (Z, W). Moreover, by introducing patient subgroups (S), it is possible to examine 3-way interactions (G T S) to test for the heterogeneity of treatment effects.

Eligibility criteria: Inclusion Criteria:

A) Youth ages 13 through 20 years, B) who have an I/DD (caregiver/self-report), and C) are enrolled in MCHB care through the IL DSCC

Exclusion Criteria:

A) Participant has a severe ID (IQ \<50) (caregiver/self-report); ( B) Participant has a reading/comprehension level below 4th grade (caregiver/self-report); or C) Participant is unable to consent to participate in the study based on the MacArthur Competency Assessment Tool Checklist of Questions (MacCAT-CR).

Primary outcomes:
measure: Depressive Symptomatology
timeFrame: Baseline through 24 months
measure: Depressive Symptomatology (additional measures for those participating in Tiers 2 and 3)
timeFrame: Baseline through 24 months
measure: Anxiety Symptomatology
timeFrame: Baseline through 24 months
measure: Major Depression Disorder and Anxiety Disorder
timeFrame: Baseline through 24 months
measure: Depressive Symptomatology of Caregiver
timeFrame: Baseline through 24 months
measure: Anxiety Symptomatology of Caregiver
timeFrame: Baseline through 24 months
Secondary outcomes:
measure: Caregiver-Reported Adaptive Functioning
timeFrame: Baseline through 24 months
measure: Youth-Reported Adaptive Functioning
timeFrame: Baseline through 24 months
measure: Health Related Quality of Life
timeFrame: Baseline through 24 months
measure: Health Behaviors - Risk Behaviors
timeFrame: Baseline through 24 months
measure: Health Behaviors - Substance Abuse
timeFrame: Baseline through 24 months
measure: Transition Readiness of Youth and Caregivers
timeFrame: Baseline through 24 months
measure: Transition Readiness of Youth
timeFrame: Baseline through 24 months
measure: Self-Efficacy
timeFrame: Baseline through 24 months
measure: Integration of Care
timeFrame: At 12 months
measure: Resilience
timeFrame: Baseline through 24 months
measure: Coping
timeFrame: Baseline through 24 months
measure: Perceived Stress of Youth and Caregivers
timeFrame: Baseline through 24 months
measure: Cognitive Style
timeFrame: Baseline through 24 months
measure: Social Health - Peer Relationships
timeFrame: Baseline through 24 months
measure: Stigma
timeFrame: Baseline through 24 months
measure: Social Support of Caregiver
timeFrame: Baseline through 24 months
measure: Adverse Childhood Experiences
timeFrame: At 12 months.
measure: Intervention Usability
timeFrame: At 12 months
measure: Intervention Acceptability
timeFrame: Baseline through 24 months
measure: Health Behaviors - Law Enforcement Interaction
timeFrame: Baseline through 24 months
Other outcomes:
measure: Sociodemographic Information
timeFrame: Baseline through 24 months
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago, Division of Specialized Care for Children
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Kristin L Berg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Benjamin W Van Voorhees, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Iulia Mihaila, PhD
role: STUDY_DIRECTOR
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