CBT/BIACA for Autism Spectrum Disorder (STAAR Trial)

Phase 2

Waitlist Available

Led By Marjorie Solomon, PH.D.

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 1 weeks (pre-treatment) to 17 weeks (treatment completion), and 29 weeks (3 month post-treatment follow-up)

Summary

This trial is testing two treatments for anxiety in children with autism: a special type of therapy and a medication called sertraline. It focuses on kids aged 8-14 who have significant anxiety. The therapy teaches coping skills, while the medication helps balance brain chemicals to reduce anxiety.

Eligible Conditions

Autism Spectrum Disorder
Autism
Anxiety

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 1 weeks (pre-treatment) to 17 weeks (treatment completion), and 29 weeks (3 month post-treatment follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 1 weeks (pre-treatment) to 17 weeks (treatment completion), and 29 weeks (3 month post-treatment follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 1 weeks (pre-treatment) to 17 weeks (treatment completion), and 29 weeks (3 month post-treatment 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

Change in Pediatric Anxiety Rating Scale

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CBT/BIACAExperimental Treatment1 Intervention

These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training.

Group II: SertralineActive Control1 Intervention

These participants will receive sertraline

Group III: Pill PlaceboPlacebo Group1 Intervention

These individuals will receive a pill placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT/BIACA

2017

Completed Phase 2

~70