Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD

Overseen By Eric Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Psychotropic, Stimulant

Disqualifiers: Bipolar, Psychotic disorder, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program where parents help their children with ASD manage anxiety. Therapists support parents through email or video calls. The goal is to make therapy more accessible for families who face barriers to traditional treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot start a new psychotropic medication within 4 weeks or a stimulant/psychoactive medication within 2 weeks before joining.

Are You a Good Fit for This Trial?

Inclusion Criteria

You are between the ages of 7-15 years at consent/assent.

The child has been diagnosed with Autism spectrum disorder (ASD).

One parent/guardian is able and willing to participate.

Exclusion Criteria

The child has been diagnosed with bipolar disorder, psychotic disorder, or intellectual disability.

The child is currently having very serious thoughts about hurting themselves or others, or they are hurting themselves and need medical help.

The child is currently receiving therapy for anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

Initial testing of the internet-based, parent-led cognitive-behavioral therapy (iCBT) for anxiety in children with ASD

4 weeks

Randomized Controlled Phase

Participants receive either iCBT-E or iCBT-EV over 12 weeks, with therapist support via email or email and videoconferencing

12 weeks

Weekly email support, 6 video calls for iCBT-EV group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iCBT-E
• iCBT-EV

How Is the Trial Designed?

Group I: iCBT-Email (iCBT-E) Experimental Treatment 1 Intervention

Parents will receive a weekly email from a therapist over the 12 weeks of treatment.

Group II: iCBT-Email and Videoconferencing (iCBT-EV) Active Control 1 Intervention

Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+