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New therapy aims to curb aggression and Self-Injury in kids without medication

NCT ID NCT05928247

Symptom relief Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a manualized behavioral therapy called Functional Communication Training (FCT) for children aged 3-17 with severe challenging behaviors like aggression and self-injury. The therapy teaches children to communicate their needs instead of acting out. Researchers will compare rates of problem behavior during assessment, treatment, and follow-up to see if the approach is effective and practical for caregivers.

What this could mean

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

Active substance
Functional Communication Training (FCT) - a behavioral therapy that teaches children to communicate instead of acting out
What this could lead to
If successful, this could provide a standardized, evidence-based therapy to reduce severe challenging behaviors in children, making it easier for caregivers to manage at home.
What could go wrong
This is a small early-stage study (30 participants) testing a manualized approach. The therapy may not work for all children, and results may not generalize to broader populations.

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 30 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

3 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. children from ages 3 to 17; 2. challenging behavior that occurs at least 10 times a day, despite previous treatment; 3. challenging behavior maintained by social positive or automatic reinforcement; 4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment; 5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free; 6. stable educational plan and placement with no anticipated changes during the child's treatment. Exclusion Criteria: 1. patients who do not meet the inclusion criteria; 2. patients currently receiving 15 or more hours per week of treatment for their challenging behavior; 3. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism); 4. a comorbid health condition or major mental disorder that would interfere with study participation; 5. occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment (Betz, 2011); 6. patients requiring changes to protective supports for self-injury or drug treatment, but the investigators will invite these patients to participate when protective supports and drug regimen are stable.

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Conditions

The condition(s) this trial relates to.

Aggression Problem Behavior Self-Injurious Behavior

As listed by the trial registrant

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

Aggression Problem behavior Self-injury

How to take part

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

  1. The places running it

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

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services

    RECRUITING

    Somerset, New Jersey, 08873, United States

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