- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445596
Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools
March 13, 2023 updated by: Western Kentucky University
Advancing the Effectiveness of Functional Communication Training for Children With Intellectual and Developmental Disabilities in Schools
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Bowling Green, Kentucky, United States, 42101
- Western Kentucky University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FCT Evaluation
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change in problem behavior
Time Frame: Problem behavior will be measured through study completion, up to 6 months
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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.
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Problem behavior will be measured through study completion, up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
December 20, 2022
Study Completion (Actual)
December 20, 2022
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 29, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-037
- 5P20GM103436-22 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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