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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
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

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pediatric Anxiety Rating Scale - ASD
Secondary outcome measures
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
1,001 Previous Clinical Trials
6,002,352 Total Patients Enrolled
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,882,227 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age threshold for taking part in this research set at 70 or younger?

"According to the enrollment requirements of this research, minors aged seven and up until 17 can be eligible for recruitment."

Answered by AI

Are there any eligibility criteria for enrolling in this trial?

"This clinical trial is recruiting approximately 60 participants with a diagnosis of Autism Spectrum Disorder, who are between the ages of 7 and 17 years old."

Answered by AI

Are there still openings available to join this medical experiment?

"Clinicaltrials.gov indicates that this study, which was posted in January 2024 and updated last September 2023, is no longer enrolling patients. However, there are 967 other trials currently seeking participants."

Answered by AI
~38 spots leftby Dec 2024