Can a simple therapy schedule stop problem behavior from coming back?
NCT ID NCT05537610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a behavioral therapy for children aged 3 to 17 who have frequent problem behavior like aggression or self-injury. The therapy uses a schedule where children sometimes get what they want and sometimes don't, to teach them that the alternative behavior works but not always. The goal is to see if this approach reduces the return of problem behavior when caregivers can't give in.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral therapy (differential reinforcement of alternative behavior with alternating reinforcement sessions)
- What this could lead to
- If successful, this could lead to a more effective behavioral therapy that reduces relapse of problem behavior in children.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not apply to everyone. The therapy is behavioral and may not work for all children.
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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3 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. boys and girls from ages 3 to 17; 2. problem behavior that occurs at least 10 times a day, despite previous treatment; 3. problem behavior maintained by social positive 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 problem 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; 6. patients requiring changes to protective supports for self-injury or drug treatment, but we 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services
RECRUITINGSomerset, New Jersey, 08873, United States
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