Cognitive Behavioral Therapy for Anxiety in Autism

(IAA Trial)

Recruiting at 1 trial location

Overseen By Erin Kang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montclair State University

Disqualifiers: Severe medical, psychiatric impairment, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12-14 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to investigate neural constructs related to anxiety symptoms in response to Facing Your Fears (FYF) treatment in autistic participants with co-occurring anxiety. Researchers will compare participants receiving immediate FYF intervention to those in the waitlist control group (receiving treatment as usual) to see if there are differences in neural constructs and anxiety symptom changes over the study period. Participants will: * Complete the Facing Your Fears (FYF) intervention if assigned to the immediate treatment group * Continue their usual treatment during a waitlist period if assigned to the control group, followed by the opportunity to participate in FYF intervention after the waiting period ends * Complete assessments of neural constructs, anxiety symptoms, and other measures

Who Is on the Research Team?

Erin Kang, PhD

Principal Investigator

Montclair State University

Are You a Good Fit for This Trial?

This trial is for autistic youth aged 8-14 with anxiety, who can speak English fluently and have a verbal IQ of 70 or above. They must show significant social behavior deficits and anxiety symptoms as indicated by specific questionnaires. A legal guardian must consent to participate in the therapy sessions alongside the child.

Inclusion Criteria

I scored 11 or above on the SCQ for social behavior issues.

I can speak English well enough to take part in the study's tests.

My verbal IQ is 70 or above, as tested.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants in the waitlist control group continue their usual treatment and are provided with referrals if needed. After the waitlist period, they have the opportunity to participate in the FYF intervention.

12-14 weeks

Weekly sessions

Treatment

Participants in the treatment group receive the Facing Your Fears (FYF) intervention, consisting of 90-minute weekly sessions focusing on psychoeducation and CBT techniques.

12-14 weeks

12-14 weekly sessions

Follow-up

Participants are monitored for changes in neural constructs and anxiety symptoms after the intervention.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Facing Your Fears (FYF) Intervention

Trial Overview The study tests how 'Facing Your Fears' (FYF), a group cognitive behavioral therapy, affects brain activity related to anxiety in autistic children compared to those on a waitlist receiving usual treatment. After waiting, control group participants will also receive FYF.

How Is the Trial Designed?

Group I: Treatment Condition: Facing Your Fears (FYF) Group Experimental Treatment 1 Intervention

The group consists of 4-6 families who will meet for 90-minute weekly sessions for 12-14 weeks. The sessions will focus on psychoeducation and implementing CBT techniques to help autistic youth and their caregivers "face their fears" and tackle their anxiety.

Group II: Waitlist-Control Condition Active Control 1 Intervention

Waitlist Control (WC) with Treatment-as-Usual (TAU). Participants in the WC arm will continue in their usual services and will be provided with referrals if needed. No specific treatment recommendations will be given.For ethical reasons, after completing the TAU waitlist period, families will be provided with an opportunity to participate in the FYF intervention.

Who Is Running the Clinical Trial?

Montclair State University

Lead Sponsor

Trials

14

Recruited

1,200+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

St. Christopher's Hospital for Children

Collaborator

Trials

10

Recruited

3,300+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+