Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05925101

Conditions

Problem Behavior

Aggression

Self Injury

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

Extinction-only condition

Rate-drop condition

Rate-hold condition

Magnitude-drop condition

Magnitude-hold condition

Study Details

Brief summary:

Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.

Conditions

Problem Behavior

Aggression

Self Injury

Study ID

NCT05925101

Start date

Jul 7, 2023

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

1. children aged 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 currently receiving 15 or more hours per week of treatment for their problem behavior;
2. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
3. a comorbid health condition or major mental disorder that would interfere with study participation;
4. 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;
5. 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

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clinical (Human) Study on Effects of Reinforcement-Rate Drop

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of treatment with extinction alone or with FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the rate of reinforcement in the rate-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the rate of reinforcement remains equal to baseline, called the rate-hold condition, which the TWML predicts will prevent an extinction burst.We will equate reinforcement magnitude (i.e., each reinforcer delivery will be 20 s) and quality (i.e., the functional reinforcer identified during the functional analysis) across the baseline and the rate-drop and rate-hold conditions (no reinforcement will be delivered in the extinction-only condition).

experimental: Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop

Based on the TWML, we hypothesize that a large drop in reinforcement magnitude at the start of treatment will increase the probability of an extinction burst. Preventing drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the magnitude of reinforcement in the magnitude-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the magnitude of reinforcement remains equal to baseline, called the magnitude-hold condition, which the TWML predicts will prevent an extinction burst. We will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and quality (i.e., the functional reinforcer identified during the functional analysis) across baseline and both FCT conditions (no reinforcement will be delivered in the extinction-only condition).

experimental: Clinical (Human) Study on Effects of Reinforcement-Quality Drop

Note: We will conduct Ex 3 with participants who display destructive behavior reinforced by access to tangible items so that we can vary reinforcement quality using the results of a paired-stimulus preference assessment. Based on the TWML, we hypothesize that a large drop in reinforcement quality at the start of FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. Therefore, we will program a large drop in the quality of reinforcement in our quality-drop condition and ensure that the quality of reinforcement remains equal to the quality of reinforcement in baseline in the quality-hold condition. In Experiment 3, we will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and magnitude (i.e., each reinforcer delivery will be 20 s) across baseline and both FCT conditions.

experimental: Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality Increase

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of FCT will increase the probability of an extinction burst but that simultaneously increasing reinforcement quality will counteract the negative effects of a drop in reinforcement rate. We will program a large drop in the rate of reinforcement in the rate-drop-only condition, and in the rate-drop/quality-increase condition we will program the same drop in reinforcement rate but also program a large increase in reinforcement quality.

Interventions

Extinction-only condition

In this condition, therapists will place destructive behavior on extinction and deliver no reinforcement for functional communication responses (FCRs).

Rate-drop condition

In this condition,we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR on a VI 15-s schedule. This change from a VI 1.5-s schedule for destructive behavior in baseline to a VI 15-s schedule for the FCR during FCT will produce a large drop in reinforcement rate during FCT relative to baseline.

Rate-hold condition

In this condition, we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR on a yoked VI 1.5-s schedule that exactly matches the rate and timing of reinforcer deliveries for destructive behavior in baseline.

Magnitude-drop condition

In this condition, we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR according to a VI 1.5-s schedule, but we will deliver the reinforcer for just 6 s each time. This change from delivering 60 s of access to the functional reinforcer following destructive behavior in baseline to delivering 6 s of reinforcer access for the FCR during FCT will produce a large reduction in the magnitude of reinforcement relative to baseline.

Magnitude-hold condition

This condition will be identical to the magnitude-drop condition except that we will deliver 60 s of access to the functional reinforcer contingent on the FCR, so that the magnitude of reinforcement will equal that delivered in baseline for destructive behavior. To ensure that the magnitude of reinforcement does not drop in the magnitude-hold condition, we will yoke the rate and timing of reinforcer deliveries for the FCR during FCT to the rate and timing of reinforcer deliveries for destructive behavior in baseline.

Quality-drop condition

In this condition, we will place destructive behavior on extinction and deliver the reinforcer from the paired-choice assessment that the participant chooses approximately 1/12th as often as the highest preference stimulus from that assessment. This change from the most preferred stimulus from the paired-choice assessment to one chosen 1/12th as often will constitute a large drop in the quality of reinforcement during FCT relative to baseline.

Quality-hold condition

We will place destructive behavior on extinction and deliver the most preferred reinforcer from the paired-choice assessment on a yoked VI 1.5-s schedule that exactly matches the rate and timing of reinforcer deliveries for destructive behavior in baseline in this condition.

Rate-drop/quality-increase condition

In this condition, we will program the same large drop in reinforcement by delivering reinforcement on a VI 15-s schedule, but we also will increase reinforcement quality by simultaneously delivering the highest quality reinforcer identified during a competing stimulus assessment. We will use the competing stimulus assessment in Ex 4 because it directly assesses the quality of alternative reinforcement relative to the quality of the reinforcer for destructive behavior, whereas the paired-choice assessment could not guarantee that the selected stimulus would be of a higher quality than the reinforcer for destructive behavior.

Primary outcome measure

  • Rate of destructive behavior [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Wayne Fisher, PhD

8488008503wayne.fisher@rutgers.edu

Serena Claiborne

8488008504sclaibor@rutgers.edu

Locations

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

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Wayne Fisher, PhD

8488008503wayne.fisher@rutgers.edu

Serena Clairborne

8488008504sclaibor@rutgers.edu

Principal Investigator:

Wayne Fisher, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Apr 29, 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 2026-04-29.