Behavioral Intervention for Disruptive Behaviors

Overseen By Serena Claiborne

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Psychoactive drugs

Disqualifiers: Rett syndrome, Degenerative conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assess and treat challenging behaviors in children using a standardized manual. It aims to find effective treatments for both severe and mild challenging behaviors by involving caregivers. The trial explores two treatment approaches: one for harmful behaviors using communication training and another for milder behaviors through a caregiver training program. This approach is part of the Manualized Assessment and Treatment Model of Challenging Behavior. Children aged 3 to 17 with challenging behaviors occurring at least 10 times daily, despite previous treatments, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative treatment methods that could benefit many families.

Will I have to stop taking my current medications?

The trial requires that participants either be on a stable medication regimen for at least 10 half-lives of each drug or be drug-free. This means you may need to maintain your current medications without changes during the study.

What prior data suggests that this behavioral intervention is safe for individuals with challenging behavior?

Research has shown that applied behavior analysis (ABA) methods, part of the Manualized Assessment and Treatment Model for Challenging Behavior, are generally well-received by families and healthcare providers. ABA changes the environment to encourage better behavior and is often used in autism treatments. Studies have found it effective in promoting positive behaviors and teaching new skills.

No specific safety concerns have been reported about ABA methods in the reviewed sources, suggesting that the treatment is generally safe. While this doesn't eliminate all risks, the absence of reported problems in past research indicates a positive safety profile for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Disruptive Behaviors trial because it explores innovative methods to manage challenging behaviors. Unlike traditional behavioral therapies that often apply a one-size-fits-all approach, this trial tailors interventions based on the function of the behavior. With Functional Communication Training (FCT) and Noncontingent Reinforcement (NCR), it focuses on teaching alternative communication strategies and uses personalized reinforcement schedules, offering caregivers flexible options. Additionally, the Research Units in Behavioral Intervention (RUBI) protocol empowers caregivers with behavior-analytic techniques through comprehensive training modules. This personalized and adaptable approach could offer more effective, practical solutions for managing both severe and mild challenging behaviors.

What evidence suggests that this trial's treatments could be effective for challenging behavior?

Research has shown that applied behavior analysis (ABA) effectively manages difficult behaviors, particularly in children and young people with autism. Studies have found that ABA uses data to guide its methods, making it a reliable way to address disruptive behaviors. In this trial, participants with very challenging behaviors will receive Functional Analysis Treatment, which may include functional communication training (FCT) to help replace negative actions with positive communication. For participants with milder challenging behaviors, the trial will use the RUBI protocol to train caregivers in applying behavior techniques effectively. Overall, research well supports these methods for their ability to reduce challenging behaviors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Challenging behavior that occurs at least 10 times a day, despite previous treatment

Challenging behavior maintained by social positive or automatic reinforcement

Stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment

Exclusion Criteria

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 (Betz, 2011)

My protective supports and medication for self-injury are stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Trial-Based Functional Analysis and Multielement Functional Analysis to identify conditions maintaining challenging behavior

4-8 weeks

Multiple sessions per week

Treatment

Implementation of function-based treatment options including Functional Communication Training and Noncontingent Reinforcement

16 weeks

Weekly sessions

Caregiver Training and Generalization

Training caregivers to implement treatment techniques and generalize treatment effects

16 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Manualized Assessment and Treatment Model of Challenging Behavior

Trial Overview

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.

How Is the Trial Designed?

Group I: Functional Analysis Treatment for Milder Challenging Behavior Experimental Treatment 1 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 Behavior Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Autism Speaks

Collaborator

Trials

36

Recruited

3,800+

Published Research Related to This Trial

Applied Behavior Analysis (ABA) has been extensively studied for over 40 years, particularly in its effectiveness for individuals diagnosed with autism spectrum disorder (ASD), demonstrating its significance in both research and clinical settings.

The paper discusses key contributions to ABA and offers recommendations for future advancements in behavioral interventions, highlighting the ongoing evolution of practices in the next 40 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Our Understanding of Behavioral Intervention: 1980 to 2020 for Individuals Diagnosed with Autism Spectrum Disorder. Leaf, JB., Cihon, JH., Ferguson, JL., et al.[2021]

A survey of Registered Behavior Technicians (RBTs) revealed that while some received adequate initial and ongoing training for working with clients exhibiting severe problem behavior, a concerning 13% reported no initial training and 29% reported no ongoing training.

The study highlighted safety concerns, as 75% of RBTs reported sustaining injuries while working, and 36% noted that their clients also experienced injuries, indicating a need for improved training and support in handling severe behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registered Behavior Technicians' Training Experiences for Severe Problem Behavior: A Survey. Ralston, AW., Brown, K.[2023]

Severe problem behaviors like self-injury and aggression in individuals with intellectual disabilities pose significant challenges for their habilitation and community integration, necessitating effective assessment and treatment strategies.

The paper provides best practice guidelines for conducting functional behavioral assessments, aiming to reduce ambiguity in outcomes from various assessment methods, which is crucial for developing effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REDUCING AMBIGUITY IN THE FUNCTIONAL ASSESSMENT OF PROBLEM BEHAVIOR. Rooker, GW., DeLeon, IG., Borrero, CS., et al.[2020]

Behavioral interventions for individuals with acquired brain injury (ABI) can effectively address challenging behaviors like aggression and withdrawal by understanding the function and purpose behind these behaviors.

A structured behavior management plan, developed through thorough assessment and data collection, can teach alternative skills and reduce unwanted behaviors, as demonstrated in a case study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applied behavior management and acquired brain injury: approaches and assessment. Yody, BB., Schaub, C., Conway, J., et al.[2019]

The study involved 36 children aged 6-17 with autism spectrum disorder (ASD) who received brief applied behavior analysis (ABA) interventions during hospitalization, showing that the intervention was well-accepted by families and staff, and led to perceived improvements in clinical severity ratings.

While the ABA intervention did not significantly change challenging behaviors as reported by parents or affect the length of hospitalization, it indicated potential benefits in staffing and restraint levels, suggesting that ABA-based interventions may be feasible and beneficial in hospital settings for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. Sanders, K., Staubitz, J., Juárez, AP., et al.[2021]

In a study of 154 children aged 3 to 16 receiving 24 months of applied behavior analysis (ABA) for autism spectrum disorder, there was limited agreement between patient-centered measures and standard outcome measures of treatment progress.

Despite an increase in children achieving meaningful gains on patient-centered goals over time, the standard measure of adaptive behavior showed a decline, highlighting the need for ongoing communication between clinicians and families to ensure treatment aligns with meaningful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance between patient-centered and adaptive behavior outcome measures after applied behavior analysis for autism. Choi, KR., Lotfizadah, AD., Bhakta, B., et al.[2023]

The Positive Behaviour Support (PBS+PLUS) intervention, explored through interviews with eight clinicians over a 12-month period, was found to enhance communication and comfort in clinical settings for individuals with acquired brain injury (ABI) and their families.

Clinicians noted challenges in implementing PBS+PLUS due to factors like high staff turnover and the need for thorough training, suggesting that better preparation and clear client expectations are essential for successful application in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical perspectives on delivering a Positive Behaviour Support intervention for challenging behaviours following acquired brain injury. Analytis, P., Hicks, AJ., Gould, KR., et al.[2023]

Challenging behaviors in individuals with autism spectrum disorder (ASD) can lead to negative outcomes, including harm to the individual and increased stress for caregivers, highlighting the need for targeted interventions.

This Special Issue presents 12 studies that explore various treatment approaches for challenging behaviors in ASD, including systematic reviews and innovative interventions, emphasizing the importance of tailored strategies for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the Special Issue: Interventions to Reduce Challenging Behavior Among Individuals With Autism Spectrum Disorder. Davis, TN., Rispoli, M.[2019]

Challenging behaviors in individuals with autism spectrum disorder (ASD) can lead to negative outcomes, including harm to the individual and increased stress for caregivers, highlighting the need for targeted interventions.

This Special Issue presents 12 studies that explore various treatment approaches for challenging behaviors in ASD, including systematic reviews and innovative interventions, emphasizing the importance of tailored strategies for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the Special Issue: Interventions to Reduce Challenging Behavior Among Individuals With Autism Spectrum Disorder. Davis, TN., Rispoli, M.[2020]

Challenging behaviors (CBs) are particularly common in individuals with severe autism spectrum disorders and intellectual disabilities, especially during the transition from late childhood to young adulthood, making effective management crucial for caregivers and patients.

The authors propose a multimodal intervention framework that combines nonpharmacologic treatments, medication, and intensive care for severe cases, supported by clinical experience and a case presentation to guide health practitioners in managing complex presentations of CBs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary treatment plan for challenging behaviors in neurodevelopmental disorders. Guinchat, V., Cravero, C., Lefèvre-Utile, J., et al.[2021]

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