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临床试验/NCT07278544
NCT07278544招募中不适用

Harnessing Communication Preferences to Enhance Its Persistence and Mitigate Relapse of Challenging Behavior

Joel E. Ringdahl2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Persistence of Communication

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Persistence of Communication

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

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

次要结局

  • Relapse of Challenging Behavior(Change in level of challenging behavior from baseline to 6 weeks post baseline with new implementer.)

研究者

发起方
Joel E. Ringdahl
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joel E. Ringdahl

Professor

University of Georgia

研究点 (2)

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