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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05445596
Other study ID # 21-037
Secondary ID 5P20GM103436-22
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 20, 2022

Study information

Verified date March 2023
Source Western Kentucky University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with intellectual and developmental disabilities (IDDs) often engage in problem behavior, and functional communication training (FCT) is a commonly used treatment for problem behavior in clinical settings. During FCT, children learn prosocial ways to request functional reinforcers (e.g., "their way") instead of using problem behavior. For example, a child who engages in self-injury to escape math instruction may be taught to exchange a break picture card to receive a brief break from the math task as an alternative to self-injury. While the efficacy of FCT is well established, less is known about its effects in school settings when procedures are necessarily adapted for feasibility. The purpose of this investigation is to develop and evaluate methods for implementing FCT for children with IDDs in school settings. The investigators will use single case experimental design, in which each participant will serve as their own control, to address the research questions. First, the investigators will evaluate the effects of providing higher quality, longer duration reinforcement for appropriate requests relative to problem behavior (e.g., 1-minute break with a preferred activity versus 20-s break alone) during FCT compared to providing equal reinforcement for appropriate requests and problem behavior. Next, the investigators will develop a treatment extension to teach children to complete academic work to gain access to their way. The investigators will use visual cues, such as a green and red index card to teach children when it is time to work and when they may access their way. The investigators will evaluate the effects of the treatment extension on academic work completion, appropriate requests, and problem behavior. Finally, the investigators will examine how visual cues influence children's behavior when educators implement intervention across different academic activities. The investigators will measure the extent to which educators implement programmed intervention procedures to inform treatment feasibility.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 11 Years
Eligibility Inclusion Criteria: Child Eligibility Criteria - Preschool or elementary school students between 3-11 years old - Has an intellectual or developmental disability - Has a functional behavior assessment and behavior intervention plan or has been identified as needing a functional behavior assessment - Exhibits problem behavior that occurs at least daily Adult Eligibility Criteria - Educator who provides direct services to the child participant Exclusion Criteria: Child Exclusion Criteria - Excessive absences from school - Problem behavior occurs less frequently than daily

Study Design


Intervention

Behavioral:
Functional communication training
Functional communication training (FCT) is a behavioral approach to treating problem behavior. During FCT, children learn to use communication to access reinforcers, instead of using problem behavior.

Locations

Country Name City State
United States Western Kentucky University Bowling Green Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Western Kentucky University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change in problem behavior The investigators will measure the frequency of problem behavior using systematic direct observation during baseline and treatment sessions. They will transform frequency of problem behavior into responses per minute and will calculate the percentage change in problem behavior during treatment sessions relative to baseline sessions at study completion. Problem behavior will be measured through study completion, up to 6 months
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