A Trial of the Launching! to Adulthood Program

NCT06868537 | Recruiting

• 1 other identifier: HSC-MS-25-0098
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the Launching intervention leads to improvements in executive functioning, co-occurring mental health symptoms, and quality of life, as measured by caregiver and self-report assessments, to assess the maintenance of treatment gains 12 weeks post-treatment and to replicate the findings of the Launching pilot study in an independent sample of young adults with ASD.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Launching intervention

Outcome Measures

Primary Outcomes (4)

• Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)

  This is a 239 item questionnaire and each is scored from 0(is not able to do this behavior) to 3 \[(always able to do this behavior)(or almost always)\] a higher number indicating better outcome

  Baseline, week 12, week 24

• Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)

  This is a 65 item questionnaire and each is scored on a 4-point Likert scale from 1(Not True) to 4(Almost Always True) for a maximum raw score of 120, higher score indicating worse outcome.

  Baseline, week 12, week 24

• Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version

  This is a 30 item questionnaire and each is scored from 1(not true for me ) to 4(true for me) for a maximum score of 120, higher score indicating better outcome.

  Baseline, week 12, week 24

• Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version

  This is a 30 item questionnaire and each is scored from 1(not true for them) to 4(true for them) for a maximum score of 120, higher score indicating better outcome.

  Baseline, week 12, week 24

Secondary Outcomes (6)

• Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

  Baseline, week 12, week 24

• Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms

  Baseline, week 12, week 24

• Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms

  Baseline, week 12, week 24

• Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)

  Baseline, week 12, week 24

• Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire

  Baseline, week 12, week 24

Study Arms (2)

Launching! to adulthood group therapy

EXPERIMENTAL

Behavioral: Launching! to adulthood group therapy

No intervention then Launching! to adulthood group therapy

ACTIVE COMPARATOR

Behavioral: Launching! to adulthood group therapy; Behavioral: standard of care

Interventions

Launching! to adulthood group therapy BEHAVIORAL

Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching.

Launching! to adulthood group therapy; No intervention then Launching! to adulthood group therapy

standard of care BEHAVIORAL

Participants will receive a list of resources

No intervention then Launching! to adulthood group therapy

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• confirmed case of ASD from a licensed mental health or medical professional
• score of \>14 on the Social Communication Questionnaire-Lifetime (SCQ-L) completed with the mother or father
• meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ASD symptom checklist
• willing and motivated to participate in the treatment
• a parent willing to participate
• verbal intelligence quotient (IQ) score \>70 as assessed by the Kaufman Brief Intelligence Test 2nd edition revised (KBIT-2-R)

You may not qualify if:

• history of a psychotic disorder or current psychotic symptoms
• suicidal ideation with intent or plan
• current alcohol or other substance use disorder rated severe
• concurrent enrollment in another clinical trial for autism spectrum disorder
• expression of unwillingness to complete study procedures

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Antonio Pagan, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Pagan, PhD

CONTACT

(713) 486-2700; Antonio.Pagan@uth.tmc.edu

Katherine Loveland, PhD

CONTACT

(713) 486-2587; Katherine.A.Loveland@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow II

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)