N/A
N=17
Resurgence as Choice: Basic and Clinical Studies
Problem Behavior · Self-injury · Communication
Bottom Line
View on ClinicalTrials.gov: NCT03423940 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate — 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional communication training (Behavioral)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate |
1; 5 | — |
| SECONDARY Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate |
2; 6 | — |
Summary
Background: Functional communication training (FCT) is a commonly used intervention for teaching appropriate communication skills to children with intellectual disabilities who exhibit severe destructive behavior. Resurgence as Choice (RaC) Theory, a quantitative model of behavior, may help to explain why treatment relapse often occurs after FCT. This project will use the predictions of RaC to improve FCT treatments.
Objective: To test the predictions made by RaC with human participants who exhibit severe destructive behavior.
Eligibility: Children between the ages of 3 and 19 who display destructive behavior that is maintained by social consequences, who have IQ and adaptive behavior scores between 35 and 70, who are on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes, and who have a stable educational plan and placement will be be eligible to enroll.
Eligibility Criteria
Inclusion Criteria
- males and females between the ages of 3 and 19;
- problem behavior (e.g., aggression, property destruction, self-injurious behavior) that has been the focus of outpatient behavioral and pharmacological treatment but continues to occur, on average, more than once per hour;
- problem behavior reinforced by social consequences (i.e., significantly higher and stable rates of the behavior in one or more social test conditions of a functional analysis [e.g., attention, escape] relative to the control condition [play] and the test condition for automatic reinforcement [alone or ignore]);
- IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate intellectual disability);
- on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes;
- stable educational plan and placement, with no anticipated changes during the study.
Exclusion Criteria
- Exclusion criteria.
- children not meeting the inclusion criteria above;
- children currently receiving intensive (i.e., 15 or more hours per week), function-based, behavioral treatment for their problem behavior through the school or another program;
- DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
- presence of a comorbid health condition (e.g., blindness) or major mental disorder (e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring frequent hospitalizations);
- children with self-injurious behavior who, based on the results of the risk assessment, cannot be exposed to baseline conditions without placing them at risk of serious or permanent harm (e.g., detached retinas);
- children requiring changes in drug treatment (but such children will be invited to participate after they meet the above criteria for a stable drug regimen).
Data sourced from ClinicalTrials.gov (NCT03423940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.