跳至主要内容
临床试验/NCT06712784
NCT06712784招募中不适用

Supporting Patients With Autism Spectrum Disorder (ASD) During Needle-related Hospital Visits Through the Use of Behavior Analytic Strategies

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles)

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC).

A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Caregivers of autistic patients who have been historically engaged in challenging behaviors during needle-related procedures at a Boston Medical Center (BMC)
  • Established BMC autistic patients (ages 3+) who have a history of engaging in challenging behaviors in the presence of needle-related medical stimuli.
  • BMC Medical Providers (i.e., phlebotomists, medical doctors, registered nurses, certified nursing assistants, registered dieticians, and medical assistants) who either: 1) order needle-related medical procedures for participants to be conducted during procedure visits and/or 2) are present to conduct the ordered procedure
  • English speaking participants

排除标准

  • Patients who are unable to visit BMC a minimum of 2 times per month
  • No history of challenging behaviors in medical appointments involving the presentation of needle(s)
  • Patients and caregivers who do not speak English or are unable to utilize interpreter services to complete assessments and surveys

研究组 & 干预措施

Treatment Packet

Experimental

3-5 autistic BMC patients who have a history of engaging in challenging behaviors during needle-related procedures who are able to attend simulation sessions at BMC at least 2 times per month. A caregiver and clinician will also be recruited for each child participant.

干预措施: Treatment Package (for both simulation and procedure sessions (Behavioral)

结局指标

主要结局

Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles)

时间窗: Baseline, on average 4 months

A challenging behavior is defined as one that is either harmful, disruptive, or difficult to manage as documented on an investigator-developed task list.

Number of task list steps completed in the absence of challenging behaviors

时间窗: Baseline, on average 4 months

This will be assessed using the investigator-developed task list.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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