Manualized Assessment and Treatment Model of Challenging Behavior

NCT05928247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

BEHAVIORAL

Research Units in Behavioral Intervention (RUBI) protocol

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.

BEHAVIORAL

Functional Communication Training (FCT)

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).

BEHAVIORAL

Non-Contingent Reinforcement (NCR)

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).

BEHAVIORAL

Competing Items and Response Blocking

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.

Sponsors & Collaborators

  • Autism Speaks

    collaborator OTHER
  • Rutgers, The State University of New Jersey

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928247 on ClinicalTrials.gov