Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05520983
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-12-19
First Post:
2022-06-28
Brief Title:
BEhavioral Health Stratified Treatment BEST Study for Youth With Intellectual andor Developmental Disabilities IDD
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
BEhavioral Health Stratified Treatment BEST to Optimize Transition to Adulthood for Youth With Intellectual andor Developmental Disabilities IDD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEST
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 andor 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 servicesresources 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 andor developmental disabilities IDD 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 depressionanxiety 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 194 million 6000 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 eg MCHB care coordination Results would guide future investment in improving outcomes for youth with IDD
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 IDD Aim 2 improving health behaviors adaptive functioning and health related quality of life among transition-age youth with IDD Aim 3 increasing health care transition HCT readiness among transition-age youth with IDD 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 IDD 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 19000 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 1selective cognitive behavioral psychoeducation Tier 2indicated cognitive-behavioral prevention groups Tier 3treatment 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 N780 N1390 N2390 transition-age youth with IDD 13-20 years from the IL MCHB Care Coordination program ie DSCC which serves a large racially geographically and socioeconomically diverse population across IL 2365 HispanicLatino 2013 African American 353 Asian 5020 White 012 American IndianNative Alaskan 006 Native Hawaiianother Pacific Islander 5700 male 4020 female 270 transgendernon binary Eligibility criteria include being a current DSCC participant aged 13-20 years with a minimum 4th grade reading level and prior diagnosed IDD IDD are chronic conditions beginning at birth or prior to age 22 years and include physical learning language andor behavioral impairments Participants must be competent to consent Exclusion criteria include severe intellectual disability ID ie IQ50 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 depressionanxiety 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
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 IDD Aim 2 improving health behaviors adaptive functioning and health related quality of life among transition-age youth with IDD Aim 3 increasing health care transition HCT readiness among transition-age youth with IDD 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 IDD 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 19000 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 1selective cognitive behavioral psychoeducation Tier 2indicated cognitive-behavioral prevention groups Tier 3treatment 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 N780 N1390 N2390 transition-age youth with IDD 13-20 years from the IL MCHB Care Coordination program ie DSCC which serves a large racially geographically and socioeconomically diverse population across IL 2365 HispanicLatino 2013 African American 353 Asian 5020 White 012 American IndianNative Alaskan 006 Native Hawaiianother Pacific Islander 5700 male 4020 female 270 transgendernon binary Eligibility criteria include being a current DSCC participant aged 13-20 years with a minimum 4th grade reading level and prior diagnosed IDD IDD are chronic conditions beginning at birth or prior to age 22 years and include physical learning language andor behavioral impairments Participants must be competent to consent Exclusion criteria include severe intellectual disability ID ie IQ50 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 depressionanxiety 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None