30 Participants Needed

Behavioral Intervention for Disruptive Behaviors

WF
SC
Overseen BySerena Claiborne
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
Must be taking: Psychoactive drugs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.

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 data supports the effectiveness of the treatment Manualized Assessment and Treatment Model of Challenging Behavior, Applied Behavior Analysis (ABA) for Challenging Behavior, Manualized Assessment and Treatment Model?

Research shows that Applied Behavior Analysis (ABA) can improve challenging behaviors in children with autism during hospital stays, with families and staff noting potential benefits. Additionally, ABA is an evidence-based approach for autism that focuses on setting and tracking individualized goals, which has been shown to improve child functional status.12345

Is the behavioral intervention for disruptive behaviors safe for humans?

The research indicates that applied behavior analysis (ABA) interventions are generally well accepted by families and clinicians, and no specific safety concerns were reported in the studies. However, some registered behavior technicians reported injuries while working with clients, suggesting a need for better training and safety measures.12678

How is the Manualized Assessment and Treatment Model of Challenging Behavior different from other treatments for disruptive behaviors?

This treatment, based on Applied Behavior Analysis (ABA), is unique because it systematically assesses and modifies challenging behaviors by understanding their function and purpose, and it is tailored to the individual's needs, unlike standard treatments that may not be as personalized.378910

Eligibility Criteria

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
Stable educational plan and placement with no anticipated changes during the child's treatment
Challenging behavior maintained by social positive or automatic reinforcement
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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.
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Timeline

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
Concordance between patient-centered and adaptive behavior outcome measures after applied behavior analysis for autism.Choi, KR., Lotfizadah, AD., Bhakta, B., et al.[2023]
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.
Applied behavior management and acquired brain injury: approaches and assessment.Yody, BB., Schaub, C., Conway, J., et al.[2019]

References

Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. [2021]
Concordance between patient-centered and adaptive behavior outcome measures after applied behavior analysis for autism. [2023]
Applied behavior management and acquired brain injury: approaches and assessment. [2019]
REDUCING AMBIGUITY IN THE FUNCTIONAL ASSESSMENT OF PROBLEM BEHAVIOR. [2020]
Clinical perspectives on delivering a Positive Behaviour Support intervention for challenging behaviours following acquired brain injury. [2023]
Registered Behavior Technicians' Training Experiences for Severe Problem Behavior: A Survey. [2023]
Introduction to the Special Issue: Interventions to Reduce Challenging Behavior Among Individuals With Autism Spectrum Disorder. [2020]
Introduction to the Special Issue: Interventions to Reduce Challenging Behavior Among Individuals With Autism Spectrum Disorder. [2019]
Advances in Our Understanding of Behavioral Intervention: 1980 to 2020 for Individuals Diagnosed with Autism Spectrum Disorder. [2021]
Multidisciplinary treatment plan for challenging behaviors in neurodevelopmental disorders. [2021]
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