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Behavioral Intervention

CBT/BIACA for Autism (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
Occupational therapy
Anxiety symptoms are considered the primary mental health problem (i.e., most impairing/distressing)
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

STAAR Trial Summary

This trial is testing whether a behavioral intervention or the medication sertraline is more effective in treating anxiety in children with ASD ages 8-14. The study involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI visits.

Eligible Conditions
  • Autism
  • Anxiety
  • Autism Spectrum Disorder

STAAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
This isn't actually a criterion. "Occupational therapy" is a type of therapy that helps people recover from physical or mental illness by learning or re-learning daily living skills. It's not an exclusion criteria for clinical trials.
Select...
Your main mental health issue is anxiety, which causes a lot of distress and difficulty in your daily life.
Select...
You have been diagnosed with Autism Spectrum Disorder (ASD).
Select...
You have severe anxiety symptoms, as determined by a score of at least 8 on the PARS Severity Scale.
Select...
You have significant symptoms of anxiety that meet the criteria for diagnosis according to specific evaluation guidelines.

STAAR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

STAAR 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
908 Previous Clinical Trials
4,704,047 Total Patients Enrolled
Marjorie Solomon, PH.D.Principal InvestigatorUC Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this trial?

"Those seeking enrolment into this medical trial should have a diagnosis of autism spectrum disorder and be aged between 8 to 14. 132 individuals are sought for inclusion in the study."

Answered by AI

Does this clinical experiment accept participants aged above 35 years?

"This clinical trial permits participants aged 8-14 to enroll, as specified by the requirements for eligibility."

Answered by AI

Is this research opportunity available for enrollees presently?

"Affirmative. According to the data hosted on clinicaltrials.gov, this research is currently seeking participants and was initially posted October 1st 2017. This study requires 132 patients from a single medical facility."

Answered by AI

What is the current enrollment capacity for this medical trial?

"Affirmative. According to information accessible on clinicaltrials.gov, this experiment is still recruiting participants and was first published in October 2017 with an update posted at the end of January 2022. The trial requires 132 volunteers from a single medical centre."

Answered by AI

Has the FDA accredited Cognitive Behavioral Therapy/Behavioral Intervention for Autism in Children and Adolescents as a valid therapeutic approach?

"The safety and efficacy of Cognitive Behavioral Therapy/Bioelectrical Impedance Analysis for Cardiovascular Applications (CBT/BIACA) is rated as a 2, since the study has only demonstrated its relative safety but not effectiveness."

Answered by AI

How is Cognitive Behavioral Therapy/Behavioral Intervention for Anxiety in Children and Adolescents typically employed?

"Cognitive behavioural therapy and acceptance-based interventions (CBT/BIACA) are a proven method for treating premenstrual dysphoric disorder as well as anxiety disorders, binge eating disorder (BED), and obsessive-compulsive disorder."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~9 spots leftby Mar 2025