Health TrialsbyHealthPanel

Manualized Assessment and Treatment Model of Challenging Behavior

ConditionsProblem BehaviorAggressionSelf-Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorRutgers, The State University of New Jersey

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

patients who do not meet the inclusion criteria;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Functional Analysis Treatment for Harmful Challenging BehaviorExperimental treatment 3 interventions
Group B: Functional Analysis Treatment for Milder Challenging BehaviorExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

Caregiver report

The investigators will compare caregiver reports of targeted problem behavior severity during treatment across the two experimental groups.

Time frame
2 years
2

Clinical Global Impressions Severity Subscale

The investigators will compare the severity of targeted topographies of problem behavior during treatment across the two experimental groups using the Clinical Global Impressions Severity Subscale. Severity is rated on a seven-point scale, ranging from 1 (normal) to 7 (among the most severe).

Time frame
2 years
3

Aberrant Behavior Checklist Irritability Subscale

The investigators will compare the generalized effects of treatment on both targeted and non-targeted problem behavior across both experimental groups using the Aberrant Behavior Checklist irritability Subscale. The irritability subscale contains 15 items. Irritability items are scored using a four-point scale, ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). A higher composite score of all irritability items indicates greater severity.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Autism Speaks

Collaborator

Source ClinicalTrials.gov
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