Launching! to Adulthood Program for Autism

Overseen By Katherine Loveland, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Psychotic disorder, Suicidal ideation, Severe substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Launching! to adulthood program treatment for autism?

The research highlights the importance of specific educational, health, social, and cognitive supports during the transition to adulthood for individuals with autism, suggesting that tailored programs like Launching! to adulthood could be beneficial. Additionally, the multi-family group psychoeducation model is noted as a promising approach for supporting individuals with autism during this transition. ^{1 2 3 4 5}

Is the Launching! to Adulthood Program for Autism safe for humans?

There is no specific safety data available for the Launching! to Adulthood Program for Autism, but general research on autism interventions suggests that adverse events (unwanted effects) are not always well-reported. It's important for researchers to improve how they track and report these events to better inform participants. ^{4 6 7 8 9}

How is the Launching! to Adulthood treatment for autism different from other treatments?

The Launching! to Adulthood program is unique because it focuses on preparing autistic individuals for adulthood by providing a comprehensive curriculum and an array of options, such as training centers and supported employment, to prevent them from 'falling through the cracks'. This approach is tailored to the diverse skills and needs of adults with autism, unlike many existing programs that are not specifically designed for this transition. ^{4 5 10 11 12}

Research Team

Antonio Pagan, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for young adults with Autism Spectrum Disorder (ASD) who are transitioning to adulthood. It aims to help them improve their daily living skills, readiness for adult life, and social understanding. Participants must meet specific criteria related to ASD diagnosis and be able to attend group therapy sessions.

Inclusion Criteria

Confirmed case of ASD from a licensed mental health or medical professional

Meets DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ASD symptom checklist

I am willing and motivated to undergo treatment.

Exclusion Criteria

I have a history of or currently experience severe mental health symptoms.

Suicidal ideation with intent or plan

Current alcohol or other substance use disorder rated severe

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Launching intervention to improve adaptive functioning, transition readiness, and social cognition

12 weeks

Weekly sessions

Follow-up

Participants are monitored for maintenance of treatment gains

12 weeks

Assessments at week 24

Treatment Details

Interventions

• Launching! to adulthood program

Trial Overview The study tests the 'Launching! to Adulthood' program against standard care in individuals with ASD. The program's effectiveness on adaptive functioning, transition readiness, social cognition, executive functioning, mental health symptoms, and quality of life will be measured through various assessments.

Participant Groups

Group I: Launching! to adulthood group therapy Experimental Treatment 1 Intervention

Group II: No intervention then Launching! to adulthood group therapy Active Control 2 Interventions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

The study found that a structured intervention program significantly improved adaptive functioning in individuals with autism spectrum disorder (ASD), with a strong correlation to the intensity of the interventions and the severity of symptoms, based on evaluations conducted over one year.

However, the intervention did not show a significant impact on the quality of life for families, indicating that while individual outcomes can improve, family dynamics may require additional support or different approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic assessment, therapeutic care and education pathways in persons with autism spectrum disorder in transition from childhood to adulthood: the Italian National Ev.A Longitudinal Project. Valenti, M., Mazza, M., Arduino, GM., et al.[2023]

Adults with autism spectrum disorders (ASD) have significantly higher rates of prescription drug use and polypharmacy compared to adults without ASD, with nearly 75% of those with ASD having over 20 prescription drug claims annually.

The study found that 85% of adults with ASD used at least one psychotropic medication, with common prescriptions including antipsychotics and anticonvulsants, highlighting the need for careful monitoring of treatment efficacy and safety due to the high rates of polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. Vohra, R., Madhavan, S., Sambamoorthi, U., et al.[2020]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

[Autism: a lifelong condition]. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic assessment, therapeutic care and education pathways in persons with autism spectrum disorder in transition from childhood to adulthood: the Italian National Ev.A Longitudinal Project. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes in adults with autism spectrum disorders: a historical perspective. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Behavior analysis and intervention for adults with autism. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Adults with autism: outcomes, family effects, and the multi-family group psychoeducation model. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenetics May Prevent Psychotropic Adverse Events in Autism Spectrum Disorder: An Observational Pilot Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Pulling back the curtain: Issues in conducting an intervention study with transition-aged youth with autism spectrum disorder and their families. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Teaching life skills to adults disabled by autism. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Stress and Coping in Autistic Young Adults. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorders: Challenges and Opportunities for Transition to Adulthood. [2018]