NCT03423940

Resurgence as Choice: Basic and Clinical Studies

Completed NA Results posted Last updated 3 September 2024

What this trial tests

NA trial testing Functional communication training in Problem Behavior in 17 participants. Completed in 2 August 2023.

Timeline

28 June 2018

Primary endpoint
31 May 2023

2 August 2023

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	17
Start date	28 June 2018
Primary completion	31 May 2023
Estimated completion	2 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Functional communication training

Conditions studied

• Problem Behavior — all drugs for Problem Behavior →
• Self-injury — all drugs for Self-injury →
• Communication — all drugs for Communication →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 3 to 19, any sex, with Problem Behavior or Self-injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate Primary · Through study completion, an average of 4 months.

Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are highest in the test condition predicted by the model to produce the highest rate of responding.

Group	Value	95% CI
Evaluation of Treatment Dosage	1
Evaluation of Size of Decrease in Alternative Reinforcement	5

Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate Secondary · Through study completion, an average of 4 months.

Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are lowest in the test condition predicted by the model to produce the lowest rate of responding.

Group	Value	95% CI
Evaluation of Treatment Dosage	2
Evaluation of Size of Decrease in Alternative Reinforcement	6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.