New therapy aims to tame emotional meltdowns in kids with autism and intellectual disability

NCT ID NCT07624448

Symptom relief Sponsor: Children's Mercy Hospital Kansas City Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study adapts a group therapy program called Regulating Together for children aged 8-12 with autism and intellectual disability who struggle with emotions like irritability and aggression. The therapy uses relaxation, mindfulness, and parent training to help kids regulate their feelings. Ten families will test the adapted program in twice-weekly sessions to see if it reduces emotional reactivity and is well-liked by caregivers and children.

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 group therapy
What this could lead to: If successful, this adapted therapy could give families practical strategies to reduce emotional outbursts and improve daily life for children with autism and intellectual disability.
What could go wrong: This is a very small, early-stage study with only 10 participants, so results may not apply to everyone. The therapy is behavioral, not a cure, and benefits may vary.

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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 10 people

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

Expected to start

Oct 2027

An estimate. Start dates often move.

Expected to finish

Aug 2028

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.

Child Participant Inclusion Criteria: * Males, females, or non-binary youth between 8 and 12 years of age * Confirmed diagnosis of Autism Spectrum Disorder (ASD) * Confirmed diagnosis of Intellectual Disability * Fluent in spoken English. * Use of flexible phrase speech or greater * Meeting clinically significant emotion dysregulation criteria * Willing to participate in twice weekly 90-minute sessions * Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable * Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant Child Participant Exclusion Criteria: * Initiation of new psychosocial intervention within 30 days prior to first day of treatment * Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis. * 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 Caregiver Inclusion Criteria: * Age ≥ 18 years * Lives and cares for their child with ASD+ID for \> 50% of the year * Fluent in spoken English. * Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly Caregiver Exclusion Criteria: -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.

Aggression autism autism spectrum disorder intellectual disability

As listed by the trial registrant

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

Autism Intellectual disabilities with other behavioral symptoms Intellectual disability

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New therapy aims to tame emotional meltdowns in kids with autism and intellectual disability

What the study statuses mean