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Can a talking therapy ease anxiety in autistic toddlers?

NCT ID NCT06221176

Symptom relief Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study is testing a behavioral therapy called 'Being Brave' to help reduce anxiety in autistic children aged 3 to 6. The therapy involves 16 weekly sessions with parents and children, using visual aids and practice exercises. Researchers will also look at biological markers to see if they can predict which children improve. The goal is to better understand how to treat anxiety in this young group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Being Brave cognitive-behavioral therapy (CBT) program
What this could lead to
If successful, this could point toward a personalized way to treat anxiety in young autistic children, using biomarkers to predict who will benefit most.
What could go wrong
This is a very small, early-stage study with only 25 participants and no control group. Results may not apply to all children, and the therapy may not reduce anxiety for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder autism autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Autism spectrum disorder

Contacts and locations

Locations

  • Boston Children's Hospital, Two Brookline Place

    Brookline, Massachusetts, 02445, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.