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A Trial of the Launching! to Adulthood Program

A Randomized Controlled Trial of the Launching! to Adulthood Program

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06868537
Enrollment
40
Registered
2025-03-11
Start date
2025-07-15
Completion date
2027-09-01
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Launching intervention

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.

Interventions

BEHAVIORALLaunching! to adulthood group therapy

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

BEHAVIORALstandard of care

Participants will receive a list of resources

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)Baseline, week 12, week 24This 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
Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)Baseline, week 12, week 24This 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.
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child versionBaseline, week 12, week 24This 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.
Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent versionBaseline, week 12, week 24This 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

MeasureTime frameDescription
Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaireBaseline, week 12, week 24This 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
Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)Baseline, week 12, week 24This 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
Change in parental stress as assessed by the Parental Stress Scale (PSS)Baseline, week 12, week 24This 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
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptomsBaseline, week 12, week 24This 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
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptomsBaseline, week 12, week 24This 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
Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)Baseline, week 12, week 24This 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

Countries

United States

Contacts

Primary ContactAntonio Pagan, PhD
Antonio.Pagan@uth.tmc.edu(713) 486-2700
Backup ContactKatherine Loveland, PhD
Katherine.A.Loveland@uth.tmc.edu(713) 486-2587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026