Problem BehaviorNCT05445596
Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools
A study testing Functional communication training in people with Problem Behavior and Intellectual Disability, run by Western Kentucky University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior, Intellectual Disability, Developmental Disorder
- What is being tested?
- Functional communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Child Exclusion Criteria
- Excessive absences from school
- Problem behavior occurs less frequently than daily
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Kentucky University
Bowling Green, Kentucky, 42101
About this study
Official title: 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.
- Being tested
- Functional communication training
- Keywords
- functional communication training, problem behavior, alternatives to extinction
- Medical subject headings
- Problem Behavior, Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional communication trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FCT Evaluation | Experimental | 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. Receives: Behavioral: Functional communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Problem behavior will be measured through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Sep 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Why it stopped: Insufficient resources to implement intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study uses single-case experimental design to identify functional relations between independent and dependent variables.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Kentucky University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445596
- Sponsor's protocol ID
- 21-037
- Other IDs
- 5P20GM103436-22
- Status last verified
- Mar 2023
- First submitted
- 23 Jun 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers plan to make data available to participants upon request and to submit results for publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Effectiveness of Functional Communication Training for Children With Intellectual and Developmental Disabilities in Schools
- ClinicalTrials.gov ID
- NCT05445596
- Acronym / sponsor ID
- 21-037
- Keywords
- functional communication training, problem behavior, alternatives to extinction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources to implement intervention
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Western Kentucky UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses single-case experimental design to identify functional relations between independent and dependent variables.
| Arm | Type | Receives |
|---|---|---|
| FCT Evaluation | Experimental | Behavioral: Functional communication trainingThis 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. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Child Exclusion Criteria
- Excessive absences from school
- Problem behavior occurs less frequently than daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional communication trainingFunctional 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. | Behavioural | FCT Evaluation |
Primary outcome
Percentage change in problem behavior
Time frame: Problem behavior will be measured through study completion, up to 6 months
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.
Results and safety
The study was stopped early (reason given: Insufficient resources to implement intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Yes. The researchers plan to make data available to participants upon request and to submit results for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional communication training in people with Problem Behavior and Intellectual Disability, run by Western Kentucky University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient resources to implement intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in problem behavior (time frame: Problem behavior will be measured through study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.