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Behavioral Intervention

Online Cognitive Behavioral Therapy for Autism and Anxiety (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

The child is able to communicate verbally

The child is between the age of 11-17 years old at enrollment

Must not have

The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder

The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up

Summary

"This trial aims to help families of autistic adolescents with anxiety by providing online cognitive behavioral therapy, as many families struggle to access traditional in-person therapy due to cost and lack of trained providers."

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

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My child can talk and express themselves with words.

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My child is between 11 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has been diagnosed with a psychotic or conduct disorder.

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My child currently has serious thoughts of harming themselves or others, needing medical help.

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My child cannot talk on their own.

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My child's medication for mood or behavior was changed recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up

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 Learning to Understand and Navigate Anxiety-Adolescent (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.

0 / 6Eligibility criteria met