AutismBRAVENCT06221176
Biomarkers Research in Anxiety for Validation and Efficacy
A study testing Being Brave in people with Autism and Autism Spectrum Disorder, run by Boston Children's Hospital at 1 site in United States.
Trial summary
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change). Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Being Brave
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3;0 and 6;11 years old
- A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
- A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
- Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
- Cognitive ability (either verbal or non-verbal IQ) > 80 using the DAS-2
- A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities.
Who cannot join
- Presence of seizures
- Premature birth (<36 weeks) or low birth weight (<2500 gms)
- Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
- Significant sensory or motor impairment (e.g., blindness)
- Major physical abnormalities
- Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
Show all 11Show fewer
- Previous CBT for anxiety
- Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
- Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
- Psychotic symptoms in the child or parents
- Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital, Two Brookline Place
Brookline, Massachusetts, 02445
About this study
Official title: Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
Read the detailed description
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
The main questions the study aims to answer are:
- To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
- To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
- To determine which biomarkers are sensitive to treatment response.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Being Brave
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Being BraveBehavioural
Being Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Being Brave Receives: Behavioral: Being Brave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.
Measured: At baseline enrollment visit and post intervention approximately 20 weeks later
Secondary outcomes (3)
Behavior Assessment System for Children (BASC-3)
The BASC-3 measures adaptive and problem behaviors in the community and home setting. It has a strong foundation in theory and research. Scores range from 20-120 with higher scores indicating greater anxiety.
Measured: At baseline enrollment visit and post intervention approximately 20 weeks later
Pediatric Anxiety Rating Scale (PARS)
The PARS is a checklist which the independent evaluating clinician completes based upon parent interview. The measure is designed to assess the severity of anxiety symptoms associated with social phobia, separation anxiety disorder, and generalized anxiety disorder. Scores range from 0-25 with higher scores indicating greater anxiety.
Measured: At baseline enrollment visit and post intervention approximately 20 weeks later
Clinical Global Impression of Anxiety (CGI-A) Interview
The CGI-A assesses severity and improvement of anxiety using a 7-point Likert scale (from "very much better" to "very much worse"). Based on information collected from the KSADSE, PARS, and Spence, the clinician will rate the global severity of the child's global anxiety and of each individual anxiety disorder. Scores range from 0-8 with higher scores indicating greater anxiety.
Measured: At baseline enrollment visit and post intervention approximately 20 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start2 Apr 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Faja, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221176
- Sponsor's protocol ID
- P00046792
- Acronym
- BRAVE
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
- ClinicalTrials.gov ID
- NCT06221176
- Acronym / sponsor ID
- BRAVE / P00046792
- Conditions
- Autism, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
Detailed description
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
The main questions the study aims to answer are:
- To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
- To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
- To determine which biomarkers are sensitive to treatment response.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Being BraveBeing Brave |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 3;0 and 6;11 years old
- A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
- A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
- Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
- Cognitive ability (either verbal or non-verbal IQ) > 80 using the DAS-2
Key exclusion criteria (11 listed)
- Presence of seizures
- Premature birth (<36 weeks) or low birth weight (<2500 gms)
- Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
- Significant sensory or motor impairment (e.g., blindness)
- Major physical abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Being BraveBeing Brave is a manualized cognitive-behavioral (CBT) intervention and includes several features that are well-aligned with the needs of autistic children: (1) an intensive parent component; (2) use of visual aids to lay out coping plans and exposure hierarchies, psychoeducation about recognizing fear and anxiety, and scripted language for coping; (3) repeated practice of well-rehearsed coping plans for novel or challenging situations; and (4) exposure exercises for social anxiety and practice of basic social skills. The intervention includes 16 weekly sessions (1 hour each). Delivery of Being Brave is flexible to allow for additional or less practice or exposure opportunities. | Behavioural | Intervention Group |
Primary outcome
Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.
3 secondary outcomes
Behavior Assessment System for Children (BASC-3)
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Pediatric Anxiety Rating Scale (PARS)
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Clinical Global Impression of Anxiety (CGI-A) Interview
Time frame: At baseline enrollment visit and post intervention approximately 20 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Being Brave in people with Autism and Autism Spectrum Disorder, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report (time frame: At baseline enrollment visit and post intervention approximately 20 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.