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Reward Adjustment Strategies for Problem Behavior
N/A
Recruiting
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial explores how changing the rate, magnitude & quality of rewards affects the risk of an extinction burst, a side effect of FCT which can increase the risk of harm to the patient.
Who is the study for?
This trial is for children aged 3 to 17 who show disruptive behaviors like aggression or self-harm at least 10 times a day, even after treatment. They must have social support and be on stable medication or drug-free, with no changes expected in their educational setting during the study.Check my eligibility
What is being tested?
The study tests how changing different aspects of reinforcement (like rate, magnitude, quality) affects the 'extinction burst,' which is an initial increase in problem behavior when trying to stop it through treatments like FCT.See study design
What are the potential side effects?
The main side effect under investigation is the 'extinction burst,' where there's a temporary rise in frequency or intensity of destructive behaviors such as aggression or self-harm at the start of treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of destructive behavior
Secondary outcome measures
Number of participants with extinction bursts
Trial Design
4Treatment groups
Experimental Treatment
Group I: Clinical (Human) Study on Effects of Reinforcement-Rate DropExperimental Treatment3 Interventions
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).
Group II: Clinical (Human) Study on Effects of Reinforcement-Quality DropExperimental Treatment2 Interventions
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.
Group III: Clinical (Human) Study on Effects of Reinforcement-Magnitude DropExperimental Treatment3 Interventions
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).
Group IV: Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality IncreaseExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,192 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3 and 17 years old.My protective supports and medication for self-injury are stable.I've been on the same mental health medication for a while or not taking any.I have been diagnosed with Rett syndrome or a similar degenerative condition.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical (Human) Study on Effects of Reinforcement-Rate Drop
- Group 2: Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop
- Group 3: Clinical (Human) Study on Effects of Reinforcement-Quality Drop
- Group 4: Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality Increase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age criterion for this experiment inclusive of those above fifty years old?
"This trial calls for participants aged between 3 to 17 years of age. There are 93 clinical trials available exclusively for minors, and 128 other studies targeting adults above 65."
Answered by AI
Who is eligible to take part in this clinical experiment?
"In order to be accepted for this trial, applicants must demonstrate aggressive behaviour and fall between the age range of 3-17. Approximately 40 individuals will be admitted into this program."
Answered by AI
To what extent is this study populated with participants?
"Affirmative. Information hosted on clinicaltrials.gov suggests that this clinical trial is actively seeking participants, with the initial posting dating back to June 1st 2023 and last edited on June 21st 2023. 40 individuals are needed across a single medical site."
Answered by AI
Are applications currently being accepted for this research initiative?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is actively seeking participants; it was initially posted on June 1st 2023 and recently updated on the 21st of June, with 40 patients required from one site."
Answered by AI
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