Harnessing Communication Preferences

NCT07278544 | Recruiting

• 2 other identifiers: VERSION000040732R01HD069377-12A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate how preference for communication approach (e.g., using a touch talker versus picture cards) impacts treatment maintenance in the context of treatment to reduce challenging behavior exhibited by individuals with intellectual and/or developmental disabilities. As well, the clinical trial will evaluate how this preference impacts treatment relapse when care providers implement intervention and will identify potential demographic variables (e.g., age and symptom severity) that affect outcomes. The main question\[s\] it aims to answer \[is/are\]: Preferred communication strategies will persist to a greater extent when intervention is disrupted, relative to less preferred communication strategies. Communication modality preference will increase persistence for individuals with lower pre-experimental symptom severity scores and higher pre-experimental communication functioning scores. We predict demographic characteristics and developmental level will not impact intervention outcomes. Two groups will be compared. Group 1 will receive initial intervention using a preferred communication strategy. Group 2 will receive initial intervention using a non preferred, but effective, communication strategy. Intervention type will then be reversed. Researchers will compare preferred and non preferred interventions on continued expression of the communication strategy when intervention is challenged. Participants will exhibit alternative appropriate communicative behavior as a means of replacing/reducing challenging behavior. This will take place using (a) preferred communication strategies and (b) non preferred communication strategies. Following successful intervention with each type of communication, intervention will be challenged and continued use of the communication strategy will be measured.

Conditions

Intellectual Disability; Autism Spectrum Disorder; Self-Injurious Behavior; Communication Disabilities; Communication, Nonverbal

Keywords

Functional communication training; Treatment maintenance; Behavioral relapse

Outcome Measures

Primary Outcomes (1)

• Persistence of Communication

  Response rate as the average of the communication rate during treatment disruption.

  Change in level of communication from baseline to 6 weeks post baseline.

Secondary Outcomes (1)

• Relapse of Challenging Behavior

  Change in level of challenging behavior from baseline to 6 weeks post baseline with new implementer.

Study Arms (2)

PrefFCT

EXPERIMENTAL

PrefFCT involves reinforcing an appropriate communicative response determined to be preferred by the individual relative to a second appropriate communicative response. During PrefFCT, participants will receive access to the functionally relevant reinforcer following occurrences of the specified communication modality. Challenging behavior will not produce any programmed consequence.

Behavioral: PrefFCT

NonPrefFCT

EXPERIMENTAL

NonPrefFCT involves reinforcing an appropriate communicative response determined to be less preferred by the individual relative to another appropriate communicative response. During NonPrefFCT, participants will receive access to the functionally relevant reinforcer following occurrences of the specified communication modality. Challenging behavior will not produce any programmed consequence.

Behavioral: NonPrefFCT

Interventions

PrefFCT BEHAVIORAL

Differential reinforcement of alternative communication and extinction of challenging behavior.

PrefFCT

NonPrefFCT BEHAVIORAL

Differential reinforcement of alternative communication and extinction of challenging behavior.

NonPrefFCT

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and older.
• Diagnosis of intellectual or developmental disability.
• Referred for assessment and treatment of challenging behavior.

You may not qualify if:

• Challenging behavior does not occur within the context of structured assessment, eliminating the ability to identify its operant function, or the behavior is deemed too dangerous to safely observe during assessment.
• Communicate functionally using vocal/verbal communication.
• Can only identify one proficient AAC strategy.

Sponsors & Collaborators

• Joel E. Ringdahl: lead
• University of Iowa: collaborator
• University of Florida: collaborator
• Virginia Polytechnic Institute and State University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Autism Spectrum Disorder; Self-Injurious Behavior; Communication Disorders; Nonverbal Communication

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joel Ringdahl, PhD

CONTACT

319-594-2071; ringdahl@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 12, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available at the time of associated publication or at the end of the performance period, whichever comes first. Data shared in DASH will be preserved for the foreseeable future as DASH does not currently have any data deprecation or sunsetting protocols.

Locations

US (2)