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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

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

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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:

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up

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.

0 / 3Eligibility criteria met