A Trial of the Launching! to Adulthood Program

Official title

A Randomized Controlled Trial of the Launching! to Adulthood Program

Overview

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

• 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

Primary outcome measures

• Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3) [Time frame: Baseline, week 12, week 24]
• Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2) [Time frame: Baseline, week 12, week 24]
• Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version [Time frame: Baseline, week 12, week 24]
• Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version [Time frame: Baseline, week 12, week 24]

Secondary outcome measures (6)

• 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]
• Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms [Time frame: Baseline, week 12, week 24]
• Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms [Time frame: Baseline, week 12, week 24]
• 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]
• Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire [Time frame: Baseline, week 12, week 24]
• Change in parental stress as assessed by the Parental Stress Scale (PSS) [Time frame: Baseline, week 12, week 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06868537 · HSC-MS-25-0098

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗