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Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools

Primary Purpose

Problem Behavior, Intellectual Disability, Developmental Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional communication training
Sponsored by
Western Kentucky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problem Behavior focused on measuring functional communication training, problem behavior, alternatives to extinction

Eligibility Criteria

3 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western Kentucky University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FCT Evaluation

Arm Description

This study uses single case experimental design in which participants will serve as their own control. Each participant will receive the treatment (functional communication training) and will participate in comparison conditions to evaluate the effects of the treatment. We will evaluate the effects of functional communication training during three treatment phases: initial implementation, schedule thinning, and generalization.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2022
Last Updated
March 13, 2023
Sponsor
Western Kentucky University
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05445596
Brief Title
Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools
Official Title
Advancing the Effectiveness of Functional Communication Training for Children With Intellectual and Developmental Disabilities in Schools
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient resources to implement intervention
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Kentucky University
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Behavior, Intellectual Disability, Developmental Disorder
Keywords
functional communication training, problem behavior, alternatives to extinction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study uses single-case experimental design to identify functional relations between independent and dependent variables.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FCT Evaluation
Arm Type
Experimental
Arm Description
This study uses single case experimental design in which participants will serve as their own control. Each participant will receive the treatment (functional communication training) and will participate in comparison conditions to evaluate the effects of the treatment. We will evaluate the effects of functional communication training during three treatment phases: initial implementation, schedule thinning, and generalization.
Intervention Type
Behavioral
Intervention Name(s)
Functional communication training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage change in problem behavior
Description
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.
Time Frame
Problem behavior will be measured through study completion, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Western Kentucky University
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The researchers plan to make data available to participants upon request and to submit results for publication.
IPD Sharing Time Frame
The informed consent form will be available to caregivers and educators immediately after signing the form. If requested, the study protocol will be sent to the caregiver after the study is complete. Participating educators will receive copies of the study protocol during the generalization phase of the study.
IPD Sharing Access Criteria
Each caregiver of a child enrolled in the study and each participating educator will be eligible to receive the above documents.

Learn more about this trial

Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools

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