Clinical trial NCT04869540: Improving Transition Outcomes for Youth With ASD in a Medicaid Accountable Care Organization
Official title: Improving Transition Outcomes for Youth With Autism Spectrum Disorder From Within a Medicaid Accountable Care Organization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Transition-aged youth (TAY)
Medicaid ACO
Got Transition toolkit
Problem solving education (PSE)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Caregivers 18+ and transition aged youth with autism ages 14-20

Inclusion Criteria:

* Speak English or Spanish

Exclusion Criteria:

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

Primary outcomes:
measure: Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD
timeFrame: Baseline
measure: 6 months PEDI-CAT ASD
timeFrame: 6 months
Secondary outcomes:
measure: Social skills
timeFrame: baseline
measure: Cognition
timeFrame: baseline
measure: Parent Functioning and Depressive Symptoms assessed by SAS-SR
timeFrame: baseline
measure: Parent Functioning and Depressive Symptoms assessed by QIDS
timeFrame: baseline
measure: Family Empowerment
timeFrame: baseline
measure: Perceived parental stress
timeFrame: baseline
measure: Parental stress
timeFrame: baseline
measure: Perceived youth stress
timeFrame: baseline
measure: Parental coping strategies
timeFrame: baseline
measure: Youth coping strategies
timeFrame: baseline
measure: Vocational and Educational Activities
timeFrame: 6 months
measure: Health Care Transition Readiness and Family Perception of Health Care Integration using TRAQ
timeFrame: 6 months
measure: Health Care Transition Readiness and Family Perception of Health Care Integration using the Pediatric Integrated Care Survey (PICS)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: