Manualized Assessment and Treatment Model of Challenging Behavior

Part of paid clinical trials in Somerset, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05928247
Status
Recruiting
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Conditions

  • Aggression
  • Problem Behavior
  • Self-Injury

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Accepted

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).
  • 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).
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Functional Analysis Treatment for Harmful Challenging Behavior
    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.
  • Experimental: Functional Analysis Treatment for Milder Challenging Behavior
    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.

Primary Outcome Measure

Rate of Problem Behavior [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and ServicesSomersetNew Jersey08873
Wayne Fisher, PhD
[email protected]
8488008503
Serena Clairborne
[email protected]
8488008504
Wayne Fisher, PhD (PRINCIPAL_INVESTIGATOR)

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

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