An interventional study of PrefFCT and NonPrefFCT in Intellectual Disability, Autism Spectrum Disorder and Self-Injurious Behavior, sponsored by Joel E. Ringdahl. Recruiting at 2 sites in United States. Open to participants aged 2 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Joel E. Ringdahl · Not applicable, Interventional, and Treatment
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.
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.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 248 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →This is the only study on the registry with Joel E. Ringdahl as lead sponsor.
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Exclusion Criteria:
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 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
Differential reinforcement of alternative communication and extinction of challenging behavior.
Differential reinforcement of alternative communication and extinction of challenging behavior.
Persistence of Communication
Response rate as the average of the communication rate during treatment disruption.
Time frame: Change in level of communication from baseline to 6 weeks post baseline.
Relapse of Challenging Behavior
Response rate as the average challenging behavior rate during treatment with new implementer.
Time frame: Change in level of challenging behavior from baseline to 6 weeks post baseline with new implementer.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
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.
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