Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05537610

Conditions

Problem Behavior

Aggression

Self-Injury

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

CDT

Control

Study Details

Brief summary:

Although behavioral treatments for decreasing destructive behavior, such as differential reinforcement of alternative behavior (DRA), are effective in the clinic, problem behavior often returns when a caregiver does not give the child their way in the natural environment (e.g., caregiver is busy with an infant sibling). This form of treatment relapse is known as resurgence. The goal of the current study is to evaluate whether alternating sessions in which the child can have their way (i.e., "on" sessions) with sessions in which the child can not have their way (i.e., "off" sessions) helps to mitigate resurgence.

Conditions

Problem Behavior

Aggression

Self-Injury

Study ID

NCT05537610

Start date

Feb 1, 2023

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Contingency-Discrimintation Training (CDT)

In this condition, the clinician will alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. According to RaC2, alternating periods of reinforcer availability and unavailability for the alternative response will teach the participant that the alternative response alone produces reinforcement but not always. The investigators predict that resurgence of problem behavior will lower, shorter lasting, and with fewer participants experiencing resurgence than those in the control group.

active comparator: Control

This condition emulates a traditional approach to treatment in which the clinician does not alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. The investigators predict that resurgence of problem behavior will higher, longer lasting, and with more participants experiencing resurgence than those in the CDT group.

Interventions

CDT

In this condition, the clinician will alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. According to RaC2, alternating periods of reinforcer availability and unavailability for the alternative response will teach the participant that the alternative response alone produces reinforcement but not always. The investigators predict that resurgence of problem behavior will lower, shorter lasting, and with fewer participants experiencing resurgence than those in the control group.

Control

This condition emulates a traditional approach to treatment in which the clinician does not alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. The investigators predict that resurgence of problem behavior will higher, longer lasting, and with more participants experiencing resurgence than those in the CDT group.

Primary outcome measure

  • Rate of problem behavior during resurgence test [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

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

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-04-17.