Skip to main content
Clinical Trials/NCT04869540
NCT04869540
Withdrawn
N/A

Improving Transition Outcomes for Youth With Autism Spectrum Disorder From Within a Medicaid Accountable Care Organization

Boston Medical Center0 sitesApril 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Boston Medical Center
Primary Endpoint
Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD
Status
Withdrawn
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2022
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline

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 PEDI-CAT ASD

Time Frame: 6 months

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.

Secondary Outcomes

  • Social skills(baseline)
  • Parent Functioning and Depressive Symptoms assessed by QIDS(baseline)
  • Family Empowerment(baseline)
  • Perceived parental stress(baseline)
  • Perceived youth stress(baseline)
  • Youth coping strategies(baseline)
  • Health Care Transition Readiness and Family Perception of Health Care Integration using TRAQ(6 months)
  • Cognition(baseline)
  • Parent Functioning and Depressive Symptoms assessed by SAS-SR(baseline)
  • Parental coping strategies(baseline)
  • Parental stress(baseline)
  • Vocational and Educational Activities(6 months)
  • Health Care Transition Readiness and Family Perception of Health Care Integration using the Pediatric Integrated Care Survey (PICS)(6 months)

Similar Trials