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New therapy aims to tame emotional storms in kids with autism

NCT ID NCT05803369

Symptom relief Sponsor: Children's Hospital Medical Center, Cincinnati 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a group therapy program called Regulating Together for children with autism who struggle with intense emotions. The program teaches children and their caregivers skills to manage emotional reactions using techniques like cognitive behavioral therapy and mindfulness. Researchers will compare it to a school-based program to see which works better. The study involves 144 children and their families.

What this could mean

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

Active substance
Regulating Together (RT) group therapy program
What this could lead to
If successful, this could provide an effective therapy option to help children with autism better control their emotions and improve daily functioning.
What could go wrong
This is a relatively small, early-stage trial (144 participants) comparing two behavioral interventions. Results may not apply to all children with autism, and the therapy requires significant caregiver involvement.

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

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

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

8 to 12 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: * Diagnosis of autism spectrum disorder (ASD) * A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test * Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R). * Caregivers and child are fluent in speaking English * Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3. * Family willing to keep prescribed medication and outside interventions stable * willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS). * The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate. Exclusion Criteria: * Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment. * any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury * Presence of comorbid major neuropsychiatric illness warranting other treatment approaches. * Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Emotional Regulation

As listed by the trial registrant

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

Autism spectrum disorder Emotion regulation

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

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