A Trial of the Launching! to Adulthood Program

The University of Texas System (UT)

Status: Enrolling

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Behavioral: standard of care; Behavioral: Launching! to adulthood group therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06868537

HSC-MS-25-0098

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Launching! to adulthood group therapy

Experimental group

Treatment:

Behavioral: Launching! to adulthood group therapy

No intervention then Launching! to adulthood group therapy

Active Comparator group

Treatment:

Behavioral: Launching! to adulthood group therapy

Behavioral: standard of care