Clinical trial NCT05599711: Transitioning Together Boston
Official title: Testing the Efficacy of an Adapted Family-Centered Autism Transition Intervention in a Safety Net Hospital Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism or Autistic Traits
Family Relations
Keywords: Multi-family group intervention sessions
Psychoeducational autism transition-to-adulthood
Problem-solving education
Quality of life of autistic youth
Goal attainment
Parent-youth dyad
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Deborah Munroe Noonan Memorial Research Fund
First posted: 2022-10-31
Enrollment: 256
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for youth:

* Age 14 to 21 years old
* Be enrolled in high school or a specialized continued schooling program for youth ages 18 to 21.
* Has been seen at BMC at least once since 2015
* Confirmation of the autism diagnosis
* Currently live at home with a parent/legal guardian
* A parent/legal guardian who meets the below criteria

Inclusion Criteria for parents:

* Age at least 21 years old
* Parent/legal guardian of a youth who meets the youth criteria
* Parent/legal guardian is comfortable reading, writing, speaking, and listening in English and/or Spanish

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)

Primary outcomes:
measure: Change in quality of life of autistic youth
timeFrame: Baseline, 3-12 months
measure: Change in transition-related goal attainment
timeFrame: Baseline, 3-12 months
measure: Change in youth problem behaviors
timeFrame: Baseline, 3-12 months
Secondary outcomes:
measure: Change in family empowerment
timeFrame: Baseline, 3-12 months
measure: Change in coping
timeFrame: Baseline, 3-12 months
measure: Change in social support
timeFrame: Baseline, 3-12 months
measure: Change in perceived burden
timeFrame: Baseline, 3-12 months
measure: Change in parental well-being
timeFrame: Baseline, 3-12 months
measure: Change in family climate
timeFrame: Baseline, 3-12 months
measure: Change in transition readiness
timeFrame: Baseline, 3-12 months
Other outcomes:
measure: Intervention acceptability, appropriateness, and feasibility
timeFrame: 3-12 months
measure: Intervention Satisfaction
timeFrame: At the conclusion of each group session
measure: Intervention Engagement
timeFrame: At the conclusion of each group session
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Emory School of Medicine
name: Jocelyn L Kuhn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center, Pediatrics
name: Mei Elansary, MD
role: PRINCIPAL_INVESTIGATOR
References: