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Behavioral Intervention

Cognitive Behavioral Therapy for Anxiety in Autism

N/A
Recruiting
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 adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>12).
Be younger than 18 years old
Must not have
The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview).
The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Awards & highlights

Summary

This trial studies if an intervention for anxiety in autistic kids can be used in community care centers.

Who is the study for?
This trial is for autistic youth aged 7-17 with an official diagnosis and significant anxiety symptoms, as confirmed by specific assessments. Participants must have a verbal IQ over 70, live in Texas or Pennsylvania, and be able to understand English/Spanish. A parent/guardian must participate. Those on stable psychotropic meds may join; however, those with psychotic disorders or severe suicidal tendencies cannot.
What is being tested?
The study tests the effectiveness of a community-based Cognitive Behavioral Therapy (CBT) program tailored for autistic youth against the usual treatment methods. It aims to see if this specialized CBT can be feasibly implemented in community care centers to help manage anxiety.
What are the potential side effects?
Since this trial involves therapy rather than medication, traditional side effects are not expected. However, participants might experience emotional discomfort or increased anxiety when discussing their feelings or confronting anxiety-provoking situations during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a teenager with high anxiety levels, as shown by my test scores.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child has been diagnosed with a psychotic disorder.
Select...
My child currently has severe thoughts of harming themselves or others, needing medical help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 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 - ASD
Secondary study objectives
Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Clinical Global Impression-Improvement

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cognitive Behavioral TherapyActive Control1 Intervention
Participants will receive cognitive behavioral therapy that has been adapted for autistic youth with anxiety. These sessions will also include components of exposure. Participants will receive therapy around once a week for 14 weeks.
Group II: Treatment as UsualPlacebo Group1 Intervention
Participants will complete treatment as usual. They will be referred to other community resources, including skills training. Additionally, participants may begin or end therapy and/or medication.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,369 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
1,492 Patients Enrolled for Autism Spectrum Disorder
University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,013,067 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,507 Patients Enrolled for Autism Spectrum Disorder
~30 spots leftby Jul 2025
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