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

NCT05445596 | Terminated

• 2 other identifiers: 21-0375P20GM103436-22
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Problem Behavior; Intellectual Disability; Developmental Disorder

Keywords

functional communication training; problem behavior; alternatives to extinction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Behavioral: Functional communication training

Interventions

Functional communication training BEHAVIORAL

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.

FCT Evaluation

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Excessive absences from school
• Problem behavior occurs less frequently than daily

Sponsors & Collaborators

• Western Kentucky University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Western Kentucky University

Bowling Green, Kentucky, 42101, United States

Location

MeSH Terms

Conditions

Problem Behavior; Intellectual Disability; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses single-case experimental design to identify functional relations between independent and dependent variables.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 6, 2022
• Study Start: September 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• Access Criteria: Each caregiver of a child enrolled in the study and each participating educator will be eligible to receive the above documents.

Locations

US (1)