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Behavioural Intervention
Behavioral Intervention for Disruptive Behaviors
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 2 years
Awards & highlights
Study Summary
This trial will assess the efficacy of a standardized approach for assessing and treating challenging behavior for those with mild or severe symptoms.
Who is the study for?
This trial is for children aged 3 to 17 who show challenging behaviors like aggression or self-harm at least ten times daily, despite past treatments. They must have consistent safety measures for self-injury and a stable medication routine or be drug-free, with no changes expected in their educational setting during the study.Check my eligibility
What is being tested?
The study tests a standardized manual (RUBI protocol) combined with strategies like Competing Items and Response Blocking, Non-Contingent Reinforcement (NCR), and Functional Communication Training (FCT) to manage severe to mild challenging behavior in children.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not applicable. However, there may be stress or frustration associated with adapting to new behavior management techniques.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 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 Problem Behavior
Secondary outcome measures
Aberrant Behavior Checklist Irritability Subscale
Caregiver report
Clinical Global Impressions Severity Subscale
Trial Design
2Treatment groups
Experimental Treatment
Group I: Functional Analysis Treatment for Milder Challenging BehaviorExperimental Treatment1 Intervention
Caregivers of patients with mild challenging behavior will receive training using the Research Units in Behavioral Intervention (RUBI) protocol informed by the functional analysis conducted as a part of the initial assessment (Bearss et al., 2018). The RUBI protocol includes 11 core modules and 7 optional modules on training caregivers to apply behavior-analytic techniques to help manage challenging behaviors.
Group II: Functional Analysis Treatment for Harmful Challenging BehaviorExperimental Treatment3 Interventions
If challenging behavior is found to be socially maintained, the investigators will recommend functional communication training (FCT) to teach a functional communication response (FCR) (e.g., touching a card with a picture of the participant consuming the reinforcer), but the investigators will also offer NCR as a potential treatment option to the caregivers. During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. If the parents choose NCR over FCT for socially maintained challenging behavior, the investigators will deliver the functional and competing reinforcers on time-based schedules. If challenging behavior is found to be automatically maintained, the investigators will recommend using NCR with competing items and response blocking for treatment. The investigators will use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of these treatments.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,202 Total Patients Enrolled
Autism SpeaksOTHER
35 Previous Clinical Trials
3,798 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My protective supports and medication for self-injury are stable.I am between 3 and 17 years old.I have been diagnosed with Rett syndrome or a similar degenerative condition.I've been on the same mental health medication for a while or not taking any.
Research Study Groups:
This trial has the following groups:- Group 1: Functional Analysis Treatment for Harmful Challenging Behavior
- Group 2: Functional Analysis Treatment for Milder Challenging Behavior
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 enrollment for this experiment currently open?
"Unfortunately, according to clinicaltrials.gov this study is not currently accepting candidates; the original post date was August 1st of 2023 and the most recent edit was on June 28th of 2023. However, there are 214 other trials in progress seeking participants right now."
Answered by AI
Is the age limit for this clinical trial set at 30 years or higher?
"The parameters for this medical study necessitate that all participants must be aged 3 to 17. Additionally, 93 trials are available for minors and 127 trails exist specifically with elderly patients in mind."
Answered by AI
Am I eligible to take part in this clinical trial?
"In order to enter into this clinical experiment, participants should display signs of aggression and be aged between 3 and 17. A total of 30 volunteers are needed for the study's completion."
Answered by AI
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