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Clinical Trials/NCT06712784
NCT06712784
Recruiting
Not Applicable

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

Boston Medical Center1 site in 1 country10 target enrollmentMarch 1, 2026

Overview

Phase
Not Applicable
Intervention
Treatment Package (for both simulation and procedure sessions
Conditions
Autism Spectrum Disorder
Sponsor
Boston Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles)
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2026
End Date
March 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Treatment Packet

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.

Intervention: Treatment Package (for both simulation and procedure sessions

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Baseline, on average 4 months

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

Study Sites (1)

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