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

NCT ID: NCT04869540

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-12-31

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.

Detailed Description

This is a randomized pilot study of 40 families of TAY with ASD. Families will be randomly allocated to study arms - not for the purpose of maximizing internal validity; but rather, to allow us to refine recruitment techniques that maximize the acceptability of randomization. Twenty families in the 'intervention refinement' arm will receive a PSE-based intervention; among this group, the model will be refined in real time - based on both experience delivering the intervention and ongoing qualitative data collection. Refinement arm participants will receive a PSE prototype based on prior initial adaptations.

Each pilot family will also be asked to participate in a semi-structured interview. The interviews will be conducted after families have experienced at least 3 PSE sessions and use their data to further refine the model and develop hypotheses concerning testable intervention targets.

Among 20 families in a control-like 'parameter estimation' arm, empiric estimates will be obtained of study parameters key to the design of a future trial. All families in this arm will receive care from providers trained in the Got Transition toolkit, and will have access to web-based resources for creating a young adult vision statement and for accessing multiple service sectors. Participants will be tracked over six-months. Consistent with pilot methods, the analysis will not emphasize comparisons across study arms

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual care

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

'Got Transition' toolkit and resources

Intervention Type: 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 + PSE

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.

Group Type: EXPERIMENTAL

Usual care

Intervention Type: OTHER

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

'Got Transition' toolkit and resources

Intervention Type: 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.

PSE intervention

Intervention Type: BEHAVIORAL

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

Interventions

Usual care

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

Intervention Type: OTHER

'Got Transition' toolkit and resources

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

Intervention Type: OTHER

PSE intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Speak English or Spanish

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Silverstein, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Other Identifiers

5K18MH120457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41693

Identifier Type: -

Identifier Source: org_study_id