Refinements of Functional Communication Training

NCT04045600 | Recruiting

• 1 other identifier: Pro2019001493
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Although treatments for problem behavior, like functional communication training (FCT), can be highly effective in the clinic, changes in the way the FCT is implemented (e.g., when transferring treatment to the home, when teachers implement treatment with poor fidelity) can result in treatment relapse. The goal of this study is to evaluate whether using treatment signals and gradually introducing materials from natural contexts can help mitigate treatment relapse during context changes and poor treatment-integrity scenarios.

Conditions

Aggression; Self-injurious Behavior

Outcome Measures

Primary Outcomes (3)

• Rate of Destructive Behavior in Renewal Test

  The investigators will measure the rate of destructive behavior following successful treatment when the FCT is implemented in a context not associated with treatment (e.g., the baseline, home-like context).

  Through study completion, an average of 3 weeks.

• Rate of Destructive Behavior in Super-Resurgence Test

  The investigators will measure the rate of destructive behavior when FCT is implemented in a context not associated with treatment (e.g., a classroom context) by an implementer who fails to reinforce the communication response. This would be similar to a busy teacher in a classroom who is unable to attend to the child due to assisting another student.

  Through study completion, an average of 3 weeks.

• Rate of Destructive Behavior in Reinstatement Test

  The investigators will measure the rate of destructive behavior when FCT is not implemented as prescribed (i.e., reinforcement is delivered on a time-based schedule, rather than following communication responses). This would be similar to a teacher who delivers breaks from work based on the school schedule (e.g., switching from math to reading) rather than the child's request for a break during the math period).

  Through study completion, an average of 3 weeks.

Study Arms (2)

Mult FCT/Trad FCT

EXPERIMENTAL

Participants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules (mult FCT) to evaluate the effects of mult FCT on renewal, super-resurgence, and reinstatement.

Behavioral: Trad FCT; Behavioral: Mult FCT

Mult FCT + Stimulus Fading/Trad FCT

EXPERIMENTAL

Participants assigned to this condition will receive both traditional FCT (trad FCT) and FCT with multiple schedules and stimulus fading (mult FCT + stimulus fading) to evaluate the effects of mult FCT and gradual fading of contextual stimuli on renewal, super-resurgence, and reinstatement.

Behavioral: Trad FCT; Behavioral: Mult FCT + Stimulus Fading

Interventions

Trad FCT BEHAVIORAL

This intervention emulates a traditional reinforcement schedule-thinning method during FCT in which clinicians program delays to reinforcement without discriminative stimuli (e.g., the child learns that some FCRs result in reinforcement and some do not). By programming reinforcement approximately every 15 s, the rate of reinforcement will be equivalent to mult FCT. During Period 1 of this project, trad FCT served as an appropriate control condition to which mult FCT could be compared.

Mult FCT + Stimulus Fading/Trad FCT; Mult FCT/Trad FCT

Mult FCT BEHAVIORAL

This intervention involves correlating discriminative stimuli (e.g., purple and yellow index cards) with times in which reinforcement for the functional communication response (FCR) is and is not available. During Period 1 of this project, this procedure resulted in rapid reduction of destructive behavior and mitigated resurgence and renewal when the discriminative stimuli were used as programmed.

Mult FCT/Trad FCT

Mult FCT + Stimulus Fading BEHAVIORAL

This condition is similar to mult FCT except that the experimenters will gradually incorporate natural stimuli (e.g., rugs, tables, lamps) into sessions to approximate target settings that may occasion relapse typically without such gradual stimulus fading.

Mult FCT + Stimulus Fading/Trad FCT

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls from ages 3 to 17
• Destructive behavior that occurs at least 10 times a day despite previous treatment
• Destructive behavior reinforced by social consequences like attention (FCT is not appropriate for automatically reinforced destructive behavior)
• 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 destructive 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 SIB during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

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

Somerset, New Jersey, 00873, United States

RECRUITING

MeSH Terms

Conditions

Aggression; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Wayne W Fisher, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne W Fisher, PhD

CONTACT

8488008503; wayne.fisher@rutgers.edu

Serena Claiborne

CONTACT

8488008504; SClaiborne@childrens-specialized.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henry Rutgers Endowed Professor of Pediatrics

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: May 3, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

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)