Clinical trial NCT06868537: A Trial of the Launching! to Adulthood Program
Official title: A Randomized Controlled Trial of the Launching! to Adulthood Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Launching intervention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
timeFrame: Baseline, week 12, week 24
measure: Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: Baseline, week 12, week 24
measure: Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version
timeFrame: Baseline, week 12, week 24
measure: Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version
timeFrame: Baseline, week 12, week 24
Secondary outcomes:
measure: Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: Baseline, week 12, week 24
measure: Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms
timeFrame: Baseline, week 12, week 24
measure: Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms
timeFrame: Baseline, week 12, week 24
measure: Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
timeFrame: Baseline, week 12, week 24
measure: Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire
timeFrame: Baseline, week 12, week 24
measure: Change in parental stress as assessed by the Parental Stress Scale (PSS)
timeFrame: Baseline, week 12, week 24
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Antonio Pagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: