Intellectual DisabilityNCT07278544
Harnessing Communication Preferences
A study testing PrefFCT and NonPrefFCT in people with Intellectual Disability and Autism Spectrum Disorder, run by Joel E. Ringdahl at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 90 years
- Conditions the study is for
- Intellectual Disability, Autism Spectrum Disorder, Self-Injurious Behavior
- What is being tested?
- PrefFCT and NonPrefFCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2025to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 2 years old and older.
- Diagnosis of intellectual or developmental disability.
- Referred for assessment and treatment of challenging behavior.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Georgia
Athens, Georgia, 30602
Joel Ringdahl, PhD, 319-594-2071, ringdahl@uga.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Kelly Schieltz, PhD, 319-356-0308, kelly-schieltz@uiowa.edu
Matthew O'Brien, PhD
About this study
Official title: Harnessing Communication Preferences to Enhance Its Persistence and Mitigate Relapse of Challenging Behavior
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]:
Read more
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.
Read the detailed description
Participants and Setting
Sixty individuals with IDD who engage in challenging behavior (e.g., aggression, self-injury, property destruction) and have little to no communication will be recruited to participate in this study (we anticipate completion of the project for at least 48 participants). Participants will include those for whom two device-based alternative and augmentative communication (AAC) strategies can be identified.
Pre-Experimental Phase
Prior to randomization, all participants will complete several assessments to establish two different functional-communication modalities that are considered device-based AAC strategies (e.g., picture card, microswitch, tablet app). Initial modalities will be identified through a validated assessment that has been shown to identify proficient communication modalities. Next, the individual's preference will be assessed between those established modalities. These assessments are the same ones conducted in our currently funded study and include a preference assessment among leisure items and activities, a functional analysis of challenging behavior, a communication-modality proficiency assessment, FCT, and a communication-modality preference assessment. From the communication modality preference assessment, a high preferred and lesser preferred modality will be identified. These modalities henceforth will be referred to as follows: preferred communication modality (PrefFCT) and lesser preferred communication modality (NonPrefFCT).
Randomization
Following the completion of all assessments in the pre-experimental phase, participants will be randomized to one of two initial conditions: PrefFCT or NonPrefFCT. Because this is a crossover design, each participant will experience the other modality condition after crossover. Further, participants will also be randomized into their implementer condition (different trained therapist versus trained caregiver) in a similar manner. After random assignment, all participants will undergo the same sequence of procedures but using the communication modality according to condition assignment.
Crossover
Following completion of FCT and disruption after initial randomization, participants will crossover to the alternative condition and complete FCT and disruption with the other communication modality, allowing for within-subjects comparisons. That is, participants who were originally assigned to the PrefFCT condition and completed FCT and disruption with their preferred communication modality will then move to the NonPrefFCT condition during the crossover phase and thus complete a second round of FCT and disruption, but with their lesser preferred communication modality. The opposite will occur for those who started in the NonPrefFCT condition.
- Conditions
- Intellectual Disability, Autism Spectrum Disorder, Self-Injurious Behavior, Communication Disabilities, Communication, Nonverbal
- Being tested
- PrefFCT, NonPrefFCT
- Keywords
- Functional communication training, Treatment maintenance, Behavioral relapse
- Medical subject headings
- Intellectual Disability, Autism Spectrum Disorder, Self-Injurious Behavior, Communication Disorders, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrefFCTBehavioural
Differential reinforcement of alternative communication and extinction of challenging behavior.
NonPrefFCTBehavioural
Differential reinforcement of alternative communication and extinction of challenging behavior.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: NonPrefFCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of Communication
Response rate as the average of the communication rate during treatment disruption.
Measured: Change in level of communication from baseline to 6 weeks post baseline.
Secondary outcomes (1)
Relapse of Challenging Behavior
Response rate as the average challenging behavior rate during treatment with new implementer.
Measured: Change in level of challenging behavior from baseline to 6 weeks post baseline with new implementer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Aug 2025
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joel E. Ringdahl
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Florida, Virginia Polytechnic Institute and State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Joel E. Ringdahl, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278544
- Sponsor's protocol ID
- VERSION00004073
- Other IDs
- 2R01HD069377-12A1
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Communication Preferences to Enhance Its Persistence and Mitigate Relapse of Challenging Behavior
- ClinicalTrials.gov ID
- NCT07278544
- Acronym / sponsor ID
- VERSION00004073
- Conditions
- Intellectual Disability, Autism Spectrum Disorder, Self-Injurious Behavior, Communication Disabilities, Communication, Nonverbal
- Keywords
- Functional communication training, Treatment maintenance, Behavioral relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joel E. RingdahlUniversity, hospital or other
- Collaborators
- University of Iowa, University of Florida, Virginia Polytechnic Institute and State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 12 Dec 2025 (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.
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.
Detailed description
Participants and Setting
Sixty individuals with IDD who engage in challenging behavior (e.g., aggression, self-injury, property destruction) and have little to no communication will be recruited to participate in this study (we anticipate completion of the project for at least 48 participants). Participants will include those for whom two device-based alternative and augmentative communication (AAC) strategies can be identified.
Pre-Experimental Phase
Prior to randomization, all participants will complete several assessments to establish two different functional-communication modalities that are considered device-based AAC strategies (e.g., picture card, microswitch, tablet app). Initial modalities will be identified through a validated assessment that has been shown to identify proficient communication modalities. Next, the individual's preference will be assessed between those established modalities. These assessments are the same ones conducted in our currently funded study and include a preference assessment among leisure items and activities, a functional analysis of challenging behavior, a communication-modality proficiency assessment, FCT, and a communication-modality preference assessment. From the communication modality preference assessment, a high preferred and lesser preferred modality will be identified. These modalities henceforth will be referred to as follows: preferred communication modality (PrefFCT) and lesser preferred communication modality (NonPrefFCT).
Randomization
Following the completion of all assessments in the pre-experimental phase, participants will be randomized to one of two initial conditions: PrefFCT or NonPrefFCT. Because this is a crossover design, each participant will experience the other modality condition after crossover. Further, participants will also be randomized into their implementer condition (different trained therapist versus trained caregiver) in a similar manner. After random assignment, all participants will undergo the same sequence of procedures but using the communication modality according to condition assignment.
Crossover
Following completion of FCT and disruption after initial randomization, participants will crossover to the alternative condition and complete FCT and disruption with the other communication modality, allowing for within-subjects comparisons. That is, participants who were originally assigned to the PrefFCT condition and completed FCT and disruption with their preferred communication modality will then move to the NonPrefFCT condition during the crossover phase and thus complete a second round of FCT and disruption, but with their lesser preferred communication modality. The opposite will occur for those who started in the NonPrefFCT condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrefFCT | Experimental | Behavioral: PrefFCTPrefFCT 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. |
| NonPrefFCT | Experimental | Behavioral: NonPrefFCTNonPrefFCT 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. |
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 2 years old and older.
- Diagnosis of intellectual or developmental disability.
- Referred for assessment and treatment of challenging behavior.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| PrefFCTDifferential reinforcement of alternative communication and extinction of challenging behavior. | Behavioural | PrefFCT |
| NonPrefFCTDifferential reinforcement of alternative communication and extinction of challenging behavior. | Behavioural | NonPrefFCT |
Primary outcome
Persistence of Communication
Time frame: Change in level of communication from baseline to 6 weeks post baseline.
Response rate as the average of the communication rate during treatment disruption.
1 secondary outcome
Relapse of Challenging Behavior
Time frame: Change in level of challenging behavior from baseline to 6 weeks post baseline with new implementer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrefFCT and NonPrefFCT in people with Intellectual Disability and Autism Spectrum Disorder, run by Joel E. Ringdahl at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Ringdahl, PhD (319-594-2071, ringdahl@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of Communication (time frame: Change in level of communication from baseline to 6 weeks post baseline.). 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 12 Dec 2025.