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Behavioral Intervention

LUNA-Adolescent for Autism Spectrum Disorder (LUNA-A Trial)

N/A
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. The child is between the age of 11-17 years old at enrollment.
2. The child is diagnosed with autism using a validated assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Childhood Autism Rating Scale-Second Edition (CARS-2), etc.).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
Awards & highlights

Summary

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Who is the study for?
This trial is for adolescents with Autism Spectrum Disorder who also experience anxiety. It's designed to help those who have trouble accessing traditional in-person therapy due to costs, location, or a lack of trained providers.
What is being tested?
The study tests an internet-delivered Cognitive-Behavioral Therapy (CBT) program called LUNA-Adolescent against the usual treatment methods. The aim is to see if this online program can effectively reduce anxiety in autistic youth.
What are the potential side effects?
Since this trial involves non-medical intervention through CBT, typical drug side effects are not expected. However, participants may experience discomfort discussing personal issues or temporary increases in anxiety when confronting fears.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD)
Secondary study objectives
Clinical Global Impression-Improvement (CGI-I)
Screen for Child Anxiety Related Disorders (SCARED)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LUNA-AdolescentActive Control1 Intervention
Dyads in the LUNA-Adolescent group will receive internet-based cognitive behavioral therapy (LUNA-Adolescent), which includes 12 weekly treatment modules, 6 bi-weekly, 30-minutes telehealth visits, and email check-ins.
Group II: Treatment as UsualPlacebo Group1 Intervention
Dyads in the standard-care cognitive behavioral therapy (CBT) group will receive 12 weekly sessions of transdiagnostic CBT for anxiety in autistic youth.

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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,013 Previous Clinical Trials
6,028,408 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
1,413 Patients Enrolled for Autism Spectrum Disorder
~93 spots leftby Apr 2026
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