BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)

NCT05520983 | Enrolling By Invitation DMC

• 1 other identifier: CHAIRb 21092401
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Transition

Keywords

Youth; Intellectual and developmental disabilities; Care coordination; Transition to adulthood; Cognitive-behavioral therapy; Adolescents; Depression; Anxiety

Outcome Measures

Primary Outcomes (6)

• Depressive Symptomatology

  The Patient Health Questionnaire Youths (PHQ-A) is a 9-item self-report measure of depressive symptomatology that has been shown to be both valid and reliable (α=.86-.89) (4-point Likert scale, 0-27 score range, higher score indicating more depressive symptoms/severity).This instrument has been used to assess depression in individuals with Autism Spectrum Disorder (ASD), cystic fibrosis and other I/DD.

  Baseline through 24 months

• Depressive Symptomatology (additional measures for those participating in Tiers 2 and 3)

  The Patient Health Questionnaire 8 (PHQ-8) is an 8-item self-report measure of depressive symptomatology that has been shown to be both valid and reliable (4-point Likert scale, 0-24 score range, higher score indicating more depressive symptoms/severity). This instrument is a version of the PHQ-9 that does not include a question regarding suicidality. Participants in Group B, Tier 2 will receive this instrument during the course of the Tier 2 intervention (online group sessions). Participants in Group B, Tier 3 will receive this instrument during the course of the Tier 3 intervention (online group sessions).

  Baseline through 24 months

• Anxiety Symptomatology

  The Generalized Anxiety Disorder (GAD-7) is a 7-item measure of anxiety symptomatology (4-point Likert scale, 0-21 score range, higher score indicating greater anxiety severity) that has been shown to be both valid and reliable (α=.92) and has been used to assess anxiety in individuals with ASD and other I/DD. Additionally, participants in Group B, Tier 2 will receive this instrument during the course of the Tier 2 intervention (online group sessions). Participants in Group B, Tier 3 will receive this instrument during the course of the Tier 3 intervention (online group sessions).

  Baseline through 24 months

• Major Depression Disorder and Anxiety Disorder

  The Mini-International Neuropsychiatric Interview for Children and Youths (MINI Kid) is a structured diagnostic interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and International Classification of Diseases, Tenth Revision (ICD-10) psychiatric disorders in children and adolescents. The 72-item (yes/no response choices) sub-scales to identify depression and anxiety disorders will be utilized. These scales have been found to be both valid and reliable, and have been used with individuals with ASD and other I/DD.

  Baseline through 24 months

• Depressive Symptomatology of Caregiver

  The Patient Health Questionnaire (PHQ-9) is a 9-item adult-report measure of depressive symptomatology (4-point Likert scale, 0-27 score range, higher score indicating more depressive symptoms/severity) that has shown to be valid and reliable (α=.86-.89).

  Baseline through 24 months

• Anxiety Symptomatology of Caregiver

  The Generalized Anxiety Disorder (GAD-7) is a 7-item measure of anxiety symptomatology (4-point Likert scale, 0-21 score range, higher score indicating greater anxiety severity) that has been shown to be both valid and reliable (α=.92).

  Baseline through 24 months

Secondary Outcomes (20)

• Caregiver-Reported Adaptive Functioning

  Baseline through 24 months

• Youth-Reported Adaptive Functioning

  Baseline through 24 months

• Health Related Quality of Life

  Baseline through 24 months

• Health Behaviors - Risk Behaviors

  Baseline through 24 months

• Health Behaviors - Substance Abuse

  Baseline through 24 months

Other Outcomes (1)

• Sociodemographic Information

  Baseline through 24 months

Study Arms (2)

Illinois MCHB Care Coordination

ACTIVE COMPARATOR

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.

Other: Maternal Child Health Bureau (MCHB) Care Coordination

Illinois MCHB Care Coordination + CHECK tiered behavioral health

EXPERIMENTAL

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.

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

Interventions

Adapted Teens Achieving Mastery over Stress (TEAMS) Treatment BEHAVIORAL

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.

Illinois MCHB Care Coordination + CHECK tiered behavioral health

Adapted Teens Achieving Mastery over Stress (TEAMS) Prevention BEHAVIORAL

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.

Illinois MCHB Care Coordination + CHECK tiered behavioral health

Adapted Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) BEHAVIORAL

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, 6-weeks, and 2-, 3-, 5-, and 5.5-months - to encourage participation in the online modules.

Illinois MCHB Care Coordination + CHECK tiered behavioral health

Strengthening Families OTHER

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/.

Illinois MCHB Care Coordination + CHECK tiered behavioral health

Virtual psycho-educational discussion groups for caregivers and participants OTHER

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 available to all participants and families in the intervention condition. Topics for the virtual discussion groups will be determined based on pilot data and input from participants and caregivers.

Illinois MCHB Care Coordination + CHECK tiered behavioral health

Maternal Child Health Bureau (MCHB) Care Coordination OTHER

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 health care access.

Illinois MCHB Care Coordination; Illinois MCHB Care Coordination + CHECK tiered behavioral health

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Wellesley College: collaborator
• The Arc of Illinois: collaborator
• University of Chicago: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

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

Chicago, Illinois, 60612, United States

Location

Related Publications (27)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Maenner MJ, Smith LE, Hong J, Makuch R, Greenberg JS, Mailick MR. Evaluation of an activities of daily living scale for adolescents and adults with developmental disabilities. Disabil Health J. 2013 Jan;6(1):8-17. doi: 10.1016/j.dhjo.2012.08.005. Epub 2012 Oct 17.

  PMID: 23260606 BACKGROUND

• Fougeyrollas P, Noreau L, Bergeron H, Cloutier R, Dion SA, St-Michel G. Social consequences of long term impairments and disabilities: conceptual approach and assessment of handicap. Int J Rehabil Res. 1998 Jun;21(2):127-41. doi: 10.1097/00004356-199806000-00002.

  PMID: 9924676 BACKGROUND

• Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.

  PMID: 10357299 BACKGROUND

• Yiengprugsawan V, Kelly M, Tawatsupa B. SF-8TM Health Survey. Springer Netherlands; 2014:5940-5942.

  BACKGROUND

• CDC. Youth Risk Behavior Survey: data summary and trends report, 2007-2017. Atlanta, GA: US Department of Health and Human Services, CDC; 2018. https://www.cdc.gov/healthyyouth/data/yrbs/pdf/trendsreport.pdf

  BACKGROUND

• Donkervoort M, Wiegerink DJ, van Meeteren J, Stam HJ, Roebroeck ME; Transition Research Group South West Netherlands. Transition to adulthood: validation of the Rotterdam Transition Profile for young adults with cerebral palsy and normal intelligence. Dev Med Child Neurol. 2009 Jan;51(1):53-62. doi: 10.1111/j.1469-8749.2008.03115.x. Epub 2008 Nov 20.

  PMID: 19021680 BACKGROUND

• Schwarzer R, & Jerusalem M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.

  BACKGROUND

• Lund AM. Measuring usability with the use questionnaire12. Usability interface. 2001;8(2):3-6.

  BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient Assessment of Chronic Illness Care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77-80. doi: 10.1007/s11606-007-0452-5. Epub 2007 Nov 21.

  PMID: 18030539 BACKGROUND

• Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

  PMID: 12964174 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Kupst MJ, Butt Z, Stoney CM, Griffith JW, Salsman JM, Folkman S, Cella D. Assessment of stress and self-efficacy for the NIH Toolbox for Neurological and Behavioral Function. Anxiety Stress Coping. 2015;28(5):531-44. doi: 10.1080/10615806.2014.994204. Epub 2015 Feb 10.

  PMID: 25577948 BACKGROUND

• Abela JR. The hopelessness theory of depression: a test of the diathesis-stress and causal mediation components in third and seventh grade children. J Abnorm Child Psychol. 2001 Jun;29(3):241-54. doi: 10.1023/a:1010333815728.

  PMID: 11411786 BACKGROUND

• Dewalt DA, Thissen D, Stucky BD, Langer MM, Morgan Dewitt E, Irwin DE, Lai JS, Yeatts KB, Gross HE, Taylor O, Varni JW. PROMIS Pediatric Peer Relationships Scale: development of a peer relationships item bank as part of social health measurement. Health Psychol. 2013 Oct;32(10):1093-103. doi: 10.1037/a0032670. Epub 2013 Jun 17.

  PMID: 23772887 BACKGROUND

• Stuart H, Milev R, Koller M. The Inventory of Stigmatizing Experiences: Its development and reliability. World Psychiatry. 2005;4:35-39.

  BACKGROUND

• Zimet GD, Dahlem NW, Zimet SG, Farley GK. The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment. 1988/03/01 1988;52(1):30-41. doi:10.1207/s15327752jpa5201_2

  BACKGROUND

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

  PMID: 9635069 BACKGROUND

• Ali A, Strydom A, Hassiotis A, Williams R, King M. A measure of perceived stigma in people with intellectual disability. Br J Psychiatry. 2008 Nov;193(5):410-5. doi: 10.1192/bjp.bp.107.045823.

  PMID: 18978324 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Developmental Disabilities

Interventions

Therapeutics; Caregivers

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Kristin L Berg, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Benjamin W Van Voorhees, MD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Iulia Mihaila, PhD

  University of Illinois at Chicago

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors at Wellesley Centers for Women B.E.S.T. Call Center (BCC) will be blinded to conditions and the assessment measures that they complete do not involve collecting any measures of the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Department of Pediatrics

Model Details: Comparative-effectiveness study of two different care coordination models

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: August 30, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)