Extensions of Resurgence as Choice

NCT05537610 | Recruiting

• 1 other identifier: Pro2022001284
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of problem behavior during resurgence test

  The investigators will compare the rates of problem behavior during the first six sessions of the resurgence test across the two experimental groups.

  5 years

Secondary Outcomes (2)

• Number of sessions to criterion

  5 years

• Number of participants with resurgence

  5 years

Study Arms (2)

Contingency-Discrimintation Training (CDT)

EXPERIMENTAL

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.

Behavioral: CDT

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

CDT BEHAVIORAL

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.

Contingency-Discrimintation Training (CDT)

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• boys and girls from ages 3 to 17;
• problem behavior that occurs at least 10 times a day, despite previous treatment;
• problem behavior maintained by social positive reinforcement;
• stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment;
• on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;
• stable educational plan and placement with no anticipated changes during the child's treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

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

Somerset, New Jersey, 08873, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior; Aggression; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Central Study Contacts

Brian Greer, PhD

CONTACT

8488008505; brian.greer@rutgers.edu

Serena Claiborne

CONTACT

8488008504; SClaiborne@childrens-specialized.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Severe Behavior Program / Assistant Director of RUCARES and CSH-RUCARES / Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 13, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The informed consent form shall be available to the caregiver immediately after caregiver signature. If requested, the study protocol will be sent to the caregiver after the study is complete.
• Access Criteria: Each caregiver of a child enrolled in the study will be eligible to receive the above documents.

Locations

US (1)