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NCT Number: NCT06868537

A 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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Launching! to adulthood group therapy

Behavioral

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

Standard of Care

Behavioral

Participants will receive a list of resources

Primary outcomes

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

    Time frame: Baseline, week 12, week 24

    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

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

    Time frame: Baseline, week 12, week 24

    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.

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

    Time frame: Baseline, week 12, week 24

    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.

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

    Time frame: Baseline, week 12, week 24

    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.

Secondary outcomes

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

    Time frame: Baseline, week 12, week 24

    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

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

    Time frame: Baseline, week 12, week 24

    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

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

    Time frame: Baseline, week 12, week 24

    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

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

    Time frame: Baseline, week 12, week 24

    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

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

    Time frame: Baseline, week 12, week 24

    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

  6. Change in parental stress as assessed by the Parental Stress Scale (PSS)

    Time frame: Baseline, week 12, week 24

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Pagan, PhD

CONTACT

[email protected]

(713) 486-2700

Katherine Loveland, PhD

CONTACT

[email protected]

(713) 486-2587

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Randomized Controlled Trial of the Launching! to Adulthood Program

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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