NCT05599711

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Feb 2023Oct 2026

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.6 years

First QC Date

October 26, 2022

Last Update Submit

November 20, 2025

Conditions

Keywords

Multi-family group intervention sessionsPsychoeducational autism transition-to-adulthoodProblem-solving educationQuality of life of autistic youthGoal attainmentParent-youth dyad

Outcome Measures

Primary Outcomes (3)

  • Change in quality of life of autistic youth

    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.

    Baseline, 3-12 months

  • Change in transition-related goal attainment

    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.

    Baseline, 3-12 months

  • Change in youth problem behaviors

    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.

    Baseline, 3-12 months

Secondary Outcomes (7)

  • Change in family empowerment

    Baseline, 3-12 months

  • Change in coping

    Baseline, 3-12 months

  • Change in social support

    Baseline, 3-12 months

  • Change in perceived burden

    Baseline, 3-12 months

  • Change in parental well-being

    Baseline, 3-12 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Intervention acceptability, appropriateness, and feasibility

    3-12 months

  • Intervention Satisfaction

    At the conclusion of each group session

  • Intervention Engagement

    At the conclusion of each group session

Study Arms (2)

Transitioning Together

EXPERIMENTAL

Participants in this arm will receive the Transitioning Together intervention in English or Spanish either at BMC, at BMC's Supporting Parents \& Resilient Kids (SPARK) Center or on BMC Zoom.

Behavioral: Transitioning Together (TT) / Juntos en la Transicion (JET)

Usual Care

ACTIVE COMPARATOR

Participants in this arm will receive a referral to usual transition-related care through the BMC Developmental and Behavioral Pediatrics (DBP) clinic/the BMC Autism Program.

Behavioral: Usual autism transition care

Interventions

1. One individual family joining session when each family dyad meets with group therapists to establish rapport and share their own unique family's background, goals, and supports. 2. A series of four 2.5-hour multi-family group psychoeducation intervention sessions focused on problem-solving education and psychoeducational autism transition-to-adulthood content which can include independence in adulthood, community involvement, guardianship and legal issues, employment and education, health and well-being.

Transitioning Together

An expedited referral will be made for participants to establish care with a BMC Autism Program Transition/Resource Specialist. Data will be abstracted from the electronic medical record on how many visits each family completes with a BMC Autism Program Transition/Resource Specialist or other BMC Developmental and Behavioral Pediatrics provider throughout the study period.

Usual Care

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jocelyn L Kuhn, PhD

    Emory School of Medicine

    PRINCIPAL INVESTIGATOR
  • Mei Elansary, MD

    Boston Medical Center, Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

February 10, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

It is not yet known if there will be a plan to make IPD available.

Locations