A Trial of the Launching! to Adulthood Program

A Randomized Controlled Trial of the Launching! to Adulthood Program

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Behavioral: Launching! to adulthood group therapy; Behavioral: standard of care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Pagán, PhD; Phone Number: (713) 486-2700; Email: Antonio.Pagan@uth.tmc.edu
• Study Contact Backup: Name: Katherine Loveland, PhD; Phone Number: (713) 486-2587; Email: Katherine.A.Loveland@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Antonio Pagán, PhD; Phone Number: (713) 486-2700; Email: Antonio.Pagan@uth.tmc.edu
      • Contact: Katherine Loveland, PhD; Phone Number: (713) 486-2587; Email: Katherine.A.Loveland@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Launching! to adulthood group therapy	Behavioral: Launching! to adulthood group therapy; Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching.
Active Comparator: No intervention then Launching! to adulthood group therapy	Behavioral: Launching! to adulthood group therapy; Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching.; Behavioral: standard of care; Participants will receive a list of resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	This is a 75 item questionnaire and each is scored from 1(never) to 3(often) for a maximum score of 225, higher number indicating worse outcome	Baseline, week 12, week 24
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms	This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher number indicating worse outcome	Baseline, week 12, week 24
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms	This is a 7 item questionnaire and each is scored from 0(not at all) to 4(nearly every day) for a maximum score of 21 , higher score indicating more anxiety	Baseline, week 12, week 24
Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)	This is a 26 item questionnaire ,with 4 domains. Each is scored from 1(very poor) to 5(very good) ,questions 3,4 and 26 are reverse scored for a maximum raw score of 120 and higher score indicating better quality of life	Baseline, week 12, week 24
Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire	This is a 9 item questionnaire. Each is scored on a 4-point Likert scale from 1(not at all) to 5(totally) ,questions 6,7 and 8 are reverse scored for a maximum score range of 9-36 and higher score indicating better quality of life	Baseline, week 12, week 24
Change in parental stress as assessed by the Parental Stress Scale (PSS)	This is a 14 item questionnaire and each item is scored from 1 (strongly disagree) to 5 (strongly agree) for a score range of 18-90, higher score indicating more stress	Baseline, week 12, week 24

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Antonio Pagán, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Launching intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HSC-MS-25-0098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No