Manualized Assessment and Treatment Model of Challenging Behavior

NCT05928247 | Recruiting

• 1 other identifier: Pro2023001075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Problem Behavior; Aggression; Self-Injury

Outcome Measures

Primary Outcomes (1)

• Rate of Problem Behavior

  The investigators will collect continuous, direct-observation measures of destructive behavior throughout all phases of the study. They will compare rates of destructive behavior during assessment, treatment, caregiver training, and followup.

  2 years

Secondary Outcomes (3)

• Caregiver report

  2 years

• Clinical Global Impressions Severity Subscale

  2 years

• Aberrant Behavior Checklist Irritability Subscale

  2 years

Study Arms (2)

Functional Analysis Treatment for Harmful Challenging Behavior

EXPERIMENTAL

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.

Behavioral: Functional Communication Training (FCT); Behavioral: Non-Contingent Reinforcement (NCR); Behavioral: Competing Items and Response Blocking

Functional Analysis Treatment for Milder Challenging Behavior

EXPERIMENTAL

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.

Behavioral: Research Units in Behavioral Intervention (RUBI) protocol

Interventions

Functional Communication Training (FCT) BEHAVIORAL

During FCT, reinforcement will be discontinued for challenging behavior and only the alternative communication response will be reinforced. For participants with challenging behavior determined to be maintained by social-positive reinforcement (attention and/or tangible), the investigators also will typically recommend using a multiple schedule FCT (mult-FCT) to signal when reinforcement is available and to thin the schedule of reinforcement to render the treatment more practical for caregivers to implement. For participants with challenging behavior determined to be maintained by social-negative reinforcement (escape), the investigators will recommend using a chained schedule FCT (chained-FCT).

Functional Analysis Treatment for Harmful Challenging Behavior

Non-Contingent Reinforcement (NCR) BEHAVIORAL

During NCR, the investigators will deliver the functional and competing reinforcers on time-based schedules and use multiple and chained schedules to signal when noncontingent reinforcement is available (similar to multiple- and chained-FCT).

Functional Analysis Treatment for Harmful Challenging Behavior

Competing Items and Response Blocking BEHAVIORAL

The investigators will conduct a competing stimulus assessment (CSA) to identify items that produce at least an 80% reduction in challenging behavior when the participant is engaged with them. The investigators will evaluate conditions in which participants have free access to the item(s), when engagement with the item(s) is prompted, and when challenging behavior is physically blocked. Treatment will include one or more of the following components: non-contingent reinforcement informed by the CSA, reinforcing adaptive behavior, and blocking challenging behavior. The investigators will also use multiple and chained schedules to thin the reinforcement schedules and increase the practicality of the this treatment. The ending duration of the S-delta component will be based on input from caregivers and the participant's school personnel.

Functional Analysis Treatment for Harmful Challenging Behavior

Research Units in Behavioral Intervention (RUBI) protocol BEHAVIORAL

Caregivers of participants with mild challenging behavior will receive training on a variety of topics, such as prevention strategies and functional communication training, throughout implementation of the RUBI protocol.

Functional Analysis Treatment for Milder Challenging Behavior

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children from ages 3 to 17;
• 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;
• on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;
• stable educational plan and placement with no anticipated changes during the child's treatment.

You may not qualify if:

• patients currently receiving 15 or more hours per week of treatment for their challenging behavior;
• DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
• 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);
• patients requiring changes to protective supports for self-injury or drug treatment, but the investigators will invite these patients to participate when protective supports and drug regimen are stable.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Autism Speaks: collaborator

Study Sites (1)

Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services

Somerset, New Jersey, 08873, United States

RECRUITING

Related Publications (1)

• Bearss, K., Johnson, C. R., Handen, B. L., Butter, E., Lecavalier, L., Smith, T., & Scahill, L. (2018). Parent training for disruptive behavior: The RUBI autism network, clinician manual. Oxford University Press.

  BACKGROUND

MeSH Terms

Conditions

Problem Behavior; Aggression; Self-Injurious Behavior

Interventions

Behavior Therapy; Clinical Protocols

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Wayne Fisher, PhD

CONTACT

8488008503; wayne.fisher@rutgers.edu

Serena Claiborne

CONTACT

8488008504; sclaibor@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of RUCARES and CSH-RUCARES/ Henry Rutgers Endowed Professor of Pediatrics

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 3, 2023
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The informed consent form shall be available to the caregiver immediately after caregiver signature. If requested, the study protocol will be sent to the caregiver after the study is complete.
• Access Criteria: Each caregiver of a child enrolled in the study will be eligible to receive the above documents.

Locations

US (1)