Improving Transition Outcomes for Youth With ASD in a Medicaid Accountable Care Organization

NCT04869540 | Withdrawn

• 2 other identifiers: H-416935K18MH120457
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.

Conditions

Autism Spectrum Disorder

Keywords

Transition-aged youth (TAY); Medicaid ACO; Got Transition toolkit; Problem solving education (PSE)

Outcome Measures

Primary Outcomes (2)

• Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD

  The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.

  Baseline

• 6 months PEDI-CAT ASD

  The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.

  6 months

Secondary Outcomes (13)

• Social skills

  baseline

• Cognition

  baseline

• Parent Functioning and Depressive Symptoms assessed by SAS-SR

  baseline

• Parent Functioning and Depressive Symptoms assessed by QIDS

  baseline

• Family Empowerment

  baseline

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Families randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources.

Other: Usual care; Other: 'Got Transition' toolkit and resources

Usual care + PSE

EXPERIMENTAL

Families randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources and will also receive a family-based problem solving eduction (PSE) intervention.

Other: Usual care; Other: 'Got Transition' toolkit and resources; Behavioral: PSE intervention

Interventions

Usual care OTHER

Evidence based care for transition-aged youth (TAY) with ASD.

Usual care; Usual care + PSE

'Got Transition' toolkit and resources OTHER

Providers will be trained in the 'Got Transition' toolkit (the systems level component of the intervention) and have access to web-based transition resources.

Usual care; Usual care + PSE

PSE intervention BEHAVIORAL

A family-based problem solving education (PSE) intervention.

Usual care + PSE

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak English or Spanish

You may not qualify if:

• Foster families
• Families in which a parent has either serious mental illness or limited cognitive capacity

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Silverstein, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share