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)

Overview

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.

Interventions

• Behavioral Adapted Teens Achieving Mastery over Stress (TEAMS) Treatment
  Teens Achieving Mastery over Stress (TEAMS) has been adapted for use with youth with I/DD. The intervention consists of virtual, manualized treatment groups for 10 weekly, 75-minute sessions plus 6 monthly, 60-minute sessions. Caregivers of participants will meet twice: weeks one and 16.
• Behavioral Adapted Teens Achieving Mastery over Stress (TEAMS) Prevention
  Teens Achieving Mastery over Stress (TEAMS) has been adapted for youth with I/DD. TEAMS Prevention is a 10-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.
• Behavioral Adapted Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT)
  Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) has been adapted for youth with I/DD. CATCH-IT is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious. All adolescents will receive 8 engagement texts during their participation in the study - at 1-week, 1-month
• Other Strengthening Families
  The Strengthening Families caregiving curriculum is an evidence-based, self-directed, virtual skills training for caregivers. Information and instructions on accessing the Strengthening Families parenting skills training curriculum will be included on the virtual resource website https://strengtheningfamilieslessons.org/.
• Other Virtual psycho-educational discussion groups for caregivers and participants
  The BEST project will host a total of 10 virtual psycho-educational workshops per year (5 for participants and 5 for caregivers) for the duration of the intervention period of the study. Workshops will be delivered remotely via Zoom and facilitated by graduate students in health/behavioral health. Simultaneous language interpreter services will be provided. Principles of universal design in learning will be applied to the content and delivery of workshops. Workshops are an optional resource avai
• Other Maternal Child Health Bureau (MCHB) Care Coordination
  MCHB Care Coordination, funded through the Social Security Act of 1935 Title V Maternal and Child Health Services Block Grant Program, is the oldest and most universal care coordination model for children with I/DD. MCHB 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 he

Primary outcome measures

• Depressive Symptomatology [Time frame: Baseline through 24 months]
• Depressive Symptomatology (additional measures for those participating in Tiers 2 and 3) [Time frame: Baseline through 24 months]
• Anxiety Symptomatology [Time frame: Baseline through 24 months]
• Major Depression Disorder and Anxiety Disorder [Time frame: Baseline through 24 months]
• Depressive Symptomatology of Caregiver [Time frame: Baseline through 24 months]
• Anxiety Symptomatology of Caregiver [Time frame: Baseline through 24 months]

Secondary outcome measures (12)

• Caregiver-Reported Adaptive Functioning [Time frame: Baseline through 24 months]
• Youth-Reported Adaptive Functioning [Time frame: Baseline through 24 months]
• Health Related Quality of Life [Time frame: Baseline through 24 months]
• Health Behaviors - Risk Behaviors [Time frame: Baseline through 24 months]
• Health Behaviors - Substance Abuse [Time frame: Baseline through 24 months]
• Transition Readiness of Youth and Caregivers [Time frame: Baseline through 24 months]
• Transition Readiness of Youth [Time frame: Baseline through 24 months]
• Self-Efficacy [Time frame: Baseline through 24 months]
• Integration of Care [Time frame: At 12 months]
• Resilience [Time frame: Baseline through 24 months]
• Coping [Time frame: Baseline through 24 months]
• Perceived Stress of Youth and Caregivers [Time frame: Baseline through 24 months]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Illinois at Chicago, Division of Specialized Care for Children — Chicago

Publications

• White PH, Cooley WC; TRANSITIONS CLINICAL REPORT AUTHORING GROUP; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF FAMILY PHYSICIANS; AMERICAN COLLEGE OF PHYSICIANS. Supporting the Health Care Transition From Adolescence to Adulthood in the Medical Home. Pediatrics. 2018 Nov;142(5):e20182587. doi: 10.1542/peds.2018-2587. Epub 2018 Oct 22. PMID 30348754
• Schwartz LA, Tuchman LK, Hobbie WL, Ginsberg JP. A social-ecological model of readiness for transition to adult-oriented care for adolescents and young adults with chronic health conditions. Child Care Health Dev. 2011 Nov;37(6):883-95. doi: 10.1111/j.1365-2214.2011.01282.x. PMID 22007989
• Jensen PT, Paul GV, LaCount S, Peng J, Spencer CH, Higgins GC, Boyle B, Kamboj M, Smallwood C, Ardoin SP. Assessment of transition readiness in adolescents and young adults with chronic health conditions. Pediatr Rheumatol Online J. 2017 Sep 9;15(1):70. doi: 10.1186/s12969-017-0197-6. PMID 28888223
• Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. PMID 18752852
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941
• Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0. PMID 11869927
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
• Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, Milo KM, Stock SL, Wilkinson B. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010 Mar;71(3):313-26. doi: 10.4088/JCP.09m05305whi. PMID 20331933

Identifiers

NCT: NCT05520983 · CHAIRb 21092401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗