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Behavioral Intervention

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)
Awards & highlights

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 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

Side effects data

From 2002 Phase 4 trial • 110 Patients • NCT00000378
3%
orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertaline
Nortriptyline

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

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
928 Previous Clinical Trials
4,720,950 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
5,833 Patients Enrolled for Autism Spectrum Disorder
Marjorie Solomon, PH.D.Principal InvestigatorUC Davis
~9 spots leftby Sep 2025
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