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Intervention Group for Autism Spectrum Disorder (BRAVE Trial)

N/A

Recruiting

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

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

Must have

Age between 3;0 and 6;11 years old

A diagnosis of anxiety disorder using DSM-5 diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 3-4 weeks later, and at post (approximately 20 weeks later)

Awards & highlights

BRAVE Trial Summary

This trial will look at four biomarkers in two different situations: predicting how well someone will respond to treatment and measuring how their response changes over time.

Who is the study for?

This trial is for children aged 3 to nearly 7 years with autism spectrum disorder and anxiety, who can speak in short phrases or sentences and have an IQ over 80. They need a parent who speaks English fluently to participate in interviews and support the 'Being Brave' training.Check my eligibility

What is being tested?

'Being Brave' is being tested as a treatment for anxiety in kids with autism. The study looks at how well it works by checking changes in four biomarkers before and after treatment to see if they can predict or measure improvement.See study design

What are the potential side effects?

Since 'Being Brave' involves behavioral therapy rather than medication, typical side effects associated with drugs are not expected. However, participating children may experience stress or discomfort during therapy sessions.

BRAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 6 years old.

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I have been diagnosed with an anxiety disorder.

BRAVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 3-4 weeks later, and at post (approximately 20 weeks later)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 3-4 weeks later, and at post (approximately 20 weeks later)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3-4 weeks later, and at post (approximately 20 weeks later) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report

Secondary outcome measures

Behavior Assessment System for Children (BASC-3)

Clinical Global Impression of Anxiety (CGI-A) Interview

Pediatric Anxiety Rating Scale (PARS)

Other outcome measures

Coping Questionnaire (CQ)

Family Life Impairment Scale (FLIS)

Late Positive Potential mean Event-related Potentials (ERPs) Amplitude

+3 more

BRAVE Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

Being Brave

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

762 Previous Clinical Trials

5,579,909 Total Patients Enrolled

20 Trials studying Autism Spectrum Disorder

5,317 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

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

Is the age bracket of patients eligible for participation in this study inclusive of individuals who have surpassed 85 years?

"To be eligible for this trial, individuals must fall within the age range of 3 to 6 years old. It is worth noting that there are a total of 260 studies available for patients below 18 years old and an additional 61 studies specifically targeting individuals over the age of 65."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently recruiting participants. The initial posting date was February 1st, 2024, and the most recent update occurred on January 14th, 2024. However, it is worth noting that there are presently 319 other active clinical trials actively seeking eligible candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarkers Research in Anxiety for Validation and Efficacy

Susan Faja 2024. "Biomarkers Research in Anxiety for Validation and Efficacy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06221176.

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