Advancing the Effectiveness of Functional Communication Training for Children With Intellectual and Developmental Disabilities in Schools
Phase: NA
Conditions: Problem Behavior, Intellectual Disability, Developmental Disorder
Sponsor: Western Kentucky University

Approved by WKU IRB 09/06/2022 
Advancing the Effectiveness of Functional Communication Training for Children With 
Intellectual and Developmental Disabilities in Schools 
NCT05445596 
 
Primary Investigator: Jessica Torelli, Ph.D., BCBA-D 
Western Kentucky University 
270-745-4054 
 
 
Sponsor: 
KY INBRE 
 
 
 

Approved by WKU IRB 09/06/2022 
Title 
Advancing the Effectiveness of Functional Communication Training for 
Children With Intellectual and Developmental Disabilities in Schools 
Methodology 
Single-case experimental design 
Study Duration 
Estimated duration is 3-6 months per participant 
Study Center 
School sites near Western Kentucky University, Bowling Green, KY 
Objectives 
Primary Objective: to evaluate the effects of functional communication 
training (FCT) with concurrent and chained schedules on rates of problem 
behavior 
Number of 
Subjects 
8 
Diagnosis and 
Main Inclusion 
Criteria 
Children will be eligible to participate if they are: (1) preschool or 
elementary school students between the ages of 3–11, (2) have an 
intellectual and/or developmental disability, (3) have a functional behavior 
assessment and behavior intervention plan or have been identified as 
needing a functional behavior assessment, and (4) exhibit problem 
behavior that occurs at least daily. Children will be excluded if they have 
excessive absences from school and if problem behavior occurs less 
frequently than daily. 
Study Product, 
Dose, Route, 
Regimen 
All participants will receive functional communication training with 
concurrent and chained schedules  
Statistical 
Methodology 
Visual analysis will be used due to use of single-case experimental design.  
 
Purpose:  
The primary purpose is to evaluate the effects of functional communication training (FCT) with 
concurrent and chained schedules on rates of problem behavior.  
 
Methods:  
 
Study Design.  
The proposed project uses single case experimental design to address the research 
questions. In each of the three project aims, each participant will be a stand-alone experimental 
design in which they serve as their own control. Their behavior will be compared across 
conditions to determine the presence or absence of functional (causal) relations between 
independent and dependent variables. For example, researchers will collect data on the 
participant’s problem behavior and prosocial communication during baseline and intervention 
conditions to evaluate whether there are systematic decreases in problem behavior and 
increases in prosocial communication when implementing the intervention relative to other 
conditions.  
Because participants will serve as their own control, they will not be assigned to different 
study groups. However, the sequence of some intervention conditions will be counterbalanced 
across participants to control for threats to internal validity. When condition sequence is 
counterbalanced, participants will be randomly assigned to a sequence.  
 
Study population and selection criteria.  
Children will be eligible to participate if they are: (1) preschool or elementary school 
students between the ages of 3–11, (2) have an intellectual and/or developmental disability, (3) 
have a functional behavior assessment and behavior intervention plan or have been identified 
as needing a functional behavior assessment, and (4) exhibit problem behavior that occurs at 

Approved by WKU IRB 09/06/2022 
least daily. Children will be excluded if they have excessive absences from school and if 
problem behavior occurs less frequently than daily. Excessive absences would prevent the 
research team from being able to conduct treatment regularly, and infrequent problem behavior 
may preclude our ability to demonstrate an intervention effect (Type II errors would be likely). 
For each student participant, we will also recruit 1–2 school staff members who provide direct 
services to the student, such as teachers or paraprofessionals. In accordance with a 
consecutive controlled case series design, the first eight student participants nominated who 
meet inclusion criteria will be included. We will recruit a total of 8 student participants and 10–12 
educators.  
 
Study Procedures.  
Procedure 
Duration 
Educator interview 
Twice (beginning and end of study) 
Educator social validity questionnaire 
Twice (middle and end of study) 
Student educational record review 
One time (beginning of study) 
Descriptive classroom observations 
1–5 times per student 
Assessment session implementation and 
observation 
1–4 hours per student 
Intervention session implementation and 
observation 
3–6 hours per week for 3–6 months per 
student 
 
 
Interviews, Questionnaires, and Record Reviews: At the beginning of the study, the 
research team will interview participating educators to gather information about the student’s 
problem behavior and assessments and interventions the school team has previously used. The 
research team will also interview educators at the end of the study to gather data on their 
perceptions of the intervention as a measure of social validity. Educators will complete a social 
validity survey at the middle and end of the study informing the acceptability, feasibility, and 
utility of the study goals, procedures, and effects. At the beginning of the study, we will review 
the student’s educational records to gather data on age, race and ethnicity, special education 
qualifying conditions, educational goals, present levels of academic and functional performance, 
functional behavior assessment results, and history with academic and behavioral intervention.  
Behavioral Observations: For each participant, there will be three types of behavioral 
observations during the study: (1) descriptive classroom observations, (2) assessment session 
observations, and (3) intervention session observations. Because we will use single case 
experimental design to evaluate effects of the intervention on student behaviors, the total 
number of sessions will vary by participant based on the clarity of outcomes observed (i.e., 
additional sessions are conducted until clear patterns are established) (Ledford & Gast, 2018). 
However, on an individual basis and in collaboration with school staff, we will identify a 
maximum number of sessions to be conducted per study phase to avoid unnecessary extended 
periods of data collection. For example, we might decide that if we do not observe a treatment 
effect in 10 sessions, we will modify treatment. 
Descriptive Classroom Observations: We will conduct between 1 and 5 descriptive 
classroom observations for each participating child. The purpose of these observations is to 
generate one or more hypotheses about why a child engages in problem behavior. During these 
observations, research staff will collect data (using electronic tablets or paper-and-pencil data 
collection forms) on child problem behaviors, academic behaviors, and social behaviors, as well 
as classroom variables potentially related to problem or appropriate behaviors (e.g., teacher 
attention, academic demands). Later in the study, we will conduct observations to evaluate the 
extent to which the child has generalized behaviors learned during intervention sessions to 
typical classroom routines. Observations may range in duration from 10–60 minutes and will be 

Approved by WKU IRB 09/06/2022 
conducted during the child’s usual instructional routines. Observers will arrange themselves as 
unobtrusively as possible in the classroom.  
Assessment Session Implementation and Observation: We will conduct assessment 
sessions over 1–2 school days for 1–2 hours per day. The purpose of these sessions is to 
directly test one or more hypotheses about why a child engages in problem behavior (Beavers 
et al., 2013; Hanley et al., 2003; Hanley, 2012). During these sessions, research staff will 
program one or more classroom variables (e.g., presentation and removal of academic tasks, 
delivery and restriction of adult attention) and research staff will collect data on student behavior 
and fidelity to programmed procedures. Each assessment session will last between 1 and 10 
minutes. Assessment sessions will be completed in the child’s usual classroom setting unless 
there is a compelling reason to complete the assessment in a separate setting, such as an 
empty classroom or office in the school building (e.g., the form of problem behavior poses a 
safety concern, such as aggression toward peers). 
Intervention Session Implementation and Observation: We will conduct intervention 
sessions 1–3 times per week for 1–2 hours per day over a period of 3–6 months. Each 
intervention session will be between 5–20 minutes long. The purpose of these observations is to 
evaluate the effects of a behavioral intervention, functional communication training (FCT; Carr & 
Durand, 1985), on problem and alternative behaviors. FCT is a differential reinforcement of 
alternative behavior procedure in which the therapist reinforces an alternative behavior, a 
functional communicative response (FCR), as an alternative to problem behavior (Tiger et al., 
2008). For example, a child who engages in self-injury to escape math instruction may be taught 
to exchange a “break, please” picture card to receive a brief break from the math task as an 
alternative to self-injury. Research staff will implement sessions and collect data on student 
behaviors and fidelity to programmed procedures. During the final phase of intervention, 
research staff will train participating educators to implement intervention sessions. Research 
staff will collect data on student and educator behaviors, including fidelity to programmed 
procedures. Each intervention session will last between 5 and 20 minutes. Intervention sessions 
will be completed in the student’s usual classroom setting unless there is a compelling reason to 
conduct the sessions in a separate setting, such as an empty classroom or office in the school 
building (e.g., topography of problem behavior poses a safety concern). If intervention sessions 
are initially implemented in a separate setting, we will transfer intervention to the student’s usual 
classroom after establishing efficacy in the separate setting.  
The intervention will have three primary phases, each of which corresponds to a project 
aim. During the first phase, we will evaluate the effects of FCT with concurrent schedules. We 
will compare two different versions of FCT to evaluate the conditions under which FCT without 
extinction reduces problem behavior and establishes alternative behavior. In the first version, 
problem and alternative behaviors will result in the same consequence (e.g., 30-s break from 
academic demands). In the second version, alternative behavior will result in longer duration, 
higher quality reinforcement relative to problem behavior. For example, exchanging a break 
picture card may result in a 1-min break with a preferred activity, while problem behavior may 
result in a 20-s break. Replicating these two conditions across days (i.e., using a single case 
reversal design) will allow us to experimentally evaluate the effects of enhancing the quality and 
duration of reinforcement for alternative behavior relative to problem behavior, informing 
conditions under which FCT with concurrent schedules is effective.  
The second phase of FCT intervention will be the treatment extension. During the 
treatment extension, we will address project aim 2, to evaluate the effects of a treatment 
package on obtaining stimulus control over FCRs and work completion, while maintaining 
reductions in problem behavior. The purpose of the treatment extension is to increase the 
practicality of the intervention by building tolerance for delays to reinforcement and teaching the 
child when high-quality reinforcement is and is not available. In other words, the student learns 
that after completing academic work requirements, requests for high-quality reinforcers will be 

Approved by WKU IRB 09/06/2022 
honored. The treatment extension package will include three components: chained schedules of 
reinforcement, demand fading, and choice. Chained schedules are a type of compound 
schedule with schedule-correlated stimuli in which completing one component schedule 
produces the next component schedule, and reinforcement becomes available contingent on 
successively completing all basic schedules (Ferster & Skinner, 1957). Demand fading is 
systematically increasing the number, duration, or difficulty of demands required to access 
reinforcement (Hagopian et al., 2011). These two components will be combined to teach the 
student when high-quality reinforcement is and is not available to acquire stimulus control over 
appropriate requests and academic work completion and to build the student’s tolerance for 
delays to reinforcement. We will incorporate choice to help maintain reductions in problem 
behavior (Royer et al., 2017), promote self-determination (Shogren et al., 2004), and promote 
engagement and academic performance (Kern et al., 1998). The student will have choice 
opportunities within and between tasks and in choosing reinforcers. Specifically, we will teach 
the student multiple communicative responses to promote their ability to individualize 
reinforcement. They will also have choices over the order of activities or specific problems to 
complete (e.g., Dunlap et al., 1991, Moes, 1998). The treatment extension phase will continue 
until the student has met the tolerance goal set in collaboration with the student’s educators 
related to the amount of work the student should be able to complete without engaging in 
problem behavior.  
During treatment extension sessions, we will teach the student when high-quality 
reinforcement is and is not available using visual cues. For example, a red index card may 
signal breaks are unavailable, while a green index card signals breaks are available. When the 
red card is present, the student will need to complete an academic work requirement (e.g., write 
two letters). After completing the work requirement, the therapist will remove the red card and 
present the green card. When the green card is present, the student may request and access 
high-quality reinforcement (e.g., 1-min break with preferred activities). As the student 
demonstrates success with shorter, easier work requirements, the therapist will progressively 
increase the number or difficulty of academic tasks. For example, by the end of the treatment 
extension, the student might be required to complete a 10-min math activity without problem 
behavior. During treatment extension sessions, visual cues will be systematically programmed 
to be present or absent, depending on the session, to address experiment 3a toward project aim 
3. In other words, during some sessions, the green and red cards will be present, and during 
other sessions, they will be absent. This will allow us to evaluate how visual cues impact 
communicative responses and academic work completion.  
After meeting the terminal goal during treatment extension sessions, we will move to the 
third stage of intervention, generalization. The purpose of this phase is to transfer treatment 
effects to natural implementers and multiple relevant educational contexts. During this phase, 
we will conduct experiment 3b addressing project aim 3, examining the role of visual cues in the 
transfer treatment effects across educational contexts and implementers. All procedures will 
remain the same as during the treatment extension, except we will systematically introduce 
educators as interventionists, and we will begin conducting intervention sessions in up to two 
generalization contexts. We will train educators on how to implement intervention sessions prior 
to their implementation, and we will provide in vivo coaching during and in between sessions. 
Generalization contexts will be instructional activities during which the student typically engaged 
in problem behavior, such as small group reading instruction. Transferring implementation to 
educators and typical educational contexts will help promote the long-term success of treatment 
when research team support is removed after study completion. 
 
Data Monitoring 
The PI will assume responsibility for monitoring the trial (rather than establishing a 
board) due to the low-risk status of the project. The PI will monitor the project’s risks by (a) 

Approved by WKU IRB 09/06/2022 
analyzing participant data following each appointment to monitor the appropriateness of the 
procedures and research design, (b) ensuring two research staff conduct independent checks of 
consent and maintain thorough records to ensure consent has been provided for each 
participating student and educator, and (c) seeking input regularly (weekly) from participating 
educators on study procedures.  
The data sources are educator interviews, social validity questionnaires, educational 
record review, and behavioral observations. Only the PI and project manager will conduct 
educator interviews and administer social validity questionnaires. Data collectors for behavioral 
observations will be trained on data collection procedures and must meet a training criterion of 
at least 85% agreement on all dependent variables across three data collection attempts prior to 
collecting study data. Interobserver agreement will assessed on at least 25% of sessions across 
participants and conditions to monitor reliability throughout the study. Sessions will be randomly 
selected for interobserver agreement, and data collectors will not know which sessions will be 
selected prior to coding. The PI will conduct data analyses using Excel and GraphPad Prism. 
Data will be stored in a secure and encrypted server. Data will be identified only by the study ID 
of the participant. The document linking participant names and IDs will be kept confidential in a 
secured office on password protected computers.  
 
Institutional Review Board 
 
The protocol, informed consent forms, and all participant materials will be submitted to 
the IRB for review and approval. Approval of both the protocol and consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review 
and approval by the IRB before the changes are implemented to the study. All changes to the 
consent form will be IRB approved; a determination will be made regarding whether previously 
consented participants need to be re-consented.  
 
Consent Process 
Parent Consent: We will seek parental consent for potential participants who meet inclusion 
criteria based on de-identified descriptions provided by educators. The consent form will include 
a description of the project purpose, procedures, and possible benefits and risks in everyday 
language. Parental consent and child assent forms will be sent home together by a school 
representative on behalf of the principal investigator (PI) and returned to the representative, who 
will then give it to the PI. Thus, informed consent for parents will be communicated by returning 
the printed form, and the PI will not be informed of any potential participants' names until written 
consent is obtained. We will ask school representatives to send an extra copy of the consent 
form for the parent/guardian to keep. The consent forms will explain to the parents/guardians 
that they are free to withdraw at any time.  
 
Educator Consent: We will obtain informed consent from at least one educator per 
student. The consent form will include a description of the project purpose, the procedures, and 
possible benefits and risks in everyday language. The PI will offer to address any questions or 
concerns practitioners have about the consent form or study in general via phone or 
teleconference meeting. Moreover, the PI will emphasize the voluntary nature of participation, 
and that they are free to end their participation in the study at any time. School personnel will 
receive an extra copy of the consent form to keep. 
 
Child Assent: We will obtain assent from any child (regardless of disability), who can 
provide it. However, we anticipate that the children who participate in this study may vary in 
terms of communication repertoires. On the parent/guardian consent form, parents will indicate 
whether their child can understand the information presented on the assent form. In child 
friendly language, the assent form will describe that the child’s parents have given permission 
for the child to work with the PI and her team, what will happen during sessions, and that the 
child may stop participation at any time with no adverse consequences. If parents indicate their 

Approved by WKU IRB 09/06/2022 
child can understand the information presented on the assent form, we will ask them to indicate 
on the consent form whether their child can provide written assent (in the form of a signature). If 
they indicate yes, then the research team will obtain written assent from the child in the 
presence of school personnel as a witness. If they indicate no, then we will obtain verbal assent 
from the child in the presence of school personnel as a witness. 
 
Protocol Deviation 
A protocol deviation is any noncompliance with the clinical trial protocol or GCP requirements. 
The noncompliance may be either on the part of the participant, the Investigator, or the study 
site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. All protocol deviations/violations should be documented using the 
Protocol Deviations/Violations CRF and submitted to the IRB according to their reporting 
guidelines. 
 
Laws and Regulations 
This clinical study will be conducted in compliance with all national laws and regulations of the 
countries in which the clinical trial is performed, as well as any applicable guidelines. The trial 
will be registered on www.clintrials.gov and on other sites, as appropriate.  
 
Publication and Data Sharing Policy 
The preparation and submittal for publication of manuscripts containing the study results shall 
be in accordance with a process determined by mutual written agreement among the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to, the Health Insurance 
Portability and Accountability Act of 1996. 
 
Study Personnel and Roles 
Jessica Torelli, Ph.D., BCBA-D 
Principal Investigator 
Responsible for all study 
related issues 
 
Conflicts of Interest 
No conflicts of interest have been reported.