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Clinical Trials/NCT05599711
NCT05599711
Active, Not Recruiting
N/A

Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting

Boston Medical Center1 site in 1 country48 target enrollmentFebruary 10, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism or Autistic Traits
Sponsor
Boston Medical Center
Enrollment
48
Locations
1
Primary Endpoint
Change in transition-related goal attainment
Status
Active, Not Recruiting
Last Updated
5 months ago

Overview

Brief Summary

A randomized controlled trial will be conducted to determine the effects of an adapted family-centered autism transition intervention called Transitioning Together/Juntos en la Transición on meaningful outcomes for families. The study will occur in a safety net hospital setting. The adapted version of this multi-family group psychoeducation intervention is delivered across one individual family joining session and four 2.5 hour multi-family group sessions. The parent and youth groups are held in separately, at the same time.

Detailed Description

Objective 1: The investigators will test the efficacy of the adapted version of Transitioning Together on youth quality of life and progress toward individual transition goals. 128 English and/or Spanish speaking families of youth ages 14-21 years will be enrolled in the study. The primary enrollment site is Boston Medical Center (BMC), an urban safety net hospital where patients predominantly (\>75%) from low-income households are served. The effects of Transitioning Together will be compared to a usual care control condition with a referral to the Transition Specialist within BMC's Developmental and Behavioral Pediatrics clinic. Youth quality of life and progress toward individual transition goals will be compared from baseline and three-to-six months following randomization. The investigators hypothesize that Transitioning Together will have a significant positive effect on youth quality of life and goal attainment across the two time points. Objective 2: Additional standardized assessments will be administered to the 128 parents and the 128 autistic youth, to examine the effects of Transitioning Together compared to the control condition on: the broader family unit's well-being, empowerment, coping skills, social support, transition readiness, and family climate. The investigators will explore whether these factors act to mediate or moderate primary or secondary study outcomes (youth quality of life and progress toward individual transition goals). These putative mediators and moderators will be assessed at the baseline and 3-to 6-months following randomization.

Registry
clinicaltrials.gov
Start Date
February 10, 2023
End Date
October 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • A primary home language for the family is not English or Spanish (the intervention and assessments are only available in English and Spanish)
  • The autistic youth currently resides independently, in supported housing, or with a foster family or other Department of Children and Families (DCF) placement
  • Either the youth or their parent/guardian chooses not to participate in the study (one cannot participate without the other)

Outcomes

Primary Outcomes

Change in transition-related goal attainment

Time Frame: Baseline, 3-12 months

The Goal Attainment Scaling will be administered to asses transition-related goal attainment. It is a valid and reliable technique to benchmark success in meeting individualized goals. Scores can range from 0 to 4 and higher scores are associated with better goal attainment.

Change in youth problem behaviors

Time Frame: Baseline, 3-12 months

The Scales of Independent Behavior-Revised Problem Behavior Scale will be administered to assess frequency and severity of problem behaviors in youth. It is a parent-report questionnaire. For problem behaviors that occurred, items scores can range from 1 to 5 for frequency and severity, with a higher score associated with higher frequency and higher severity of the problem behavior.

Change in quality of life of autistic youth

Time Frame: Baseline, 3-12 months

The Global Health, Emotional Distress, Subjective Well-Being, and Relationships sub scales of the NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) will be administered via parent proxy (and youth self-report when appropriate) to asses the quality of life for autistic youth. Item scores can range from 1 to 5 and higher scores are associated with a higher quality of life.

Secondary Outcomes

  • Change in social support(Baseline, 3-12 months)
  • Change in parental well-being(Baseline, 3-12 months)
  • Change in transition readiness(Baseline, 3-12 months)
  • Change in perceived burden(Baseline, 3-12 months)
  • Change in family climate(Baseline, 3-12 months)
  • Change in family empowerment(Baseline, 3-12 months)
  • Change in coping(Baseline, 3-12 months)

Study Sites (1)

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