Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Treatment Package (for both simulation and procedure sessions

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline McKendry, MS BCBA LABA; Phone Number: 617 414 3874; Email: jacqueline.mckendry@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Jacqueline McKendry, MS BCBA LABA; Phone Number: 617-414-3874; Email: jacqueline.mckendry@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Treatment Package (for both simulation and procedure sessions; Treatment Package for both simulation and procedure sessions will include visit priming (contingency specifying stimuli in the form of social stories and YouTube videos) and differential reinforcement of alternative behavior (DRA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles)	A challenging behavior is defined as one that is either harmful, disruptive, or difficult to manage as documented on an investigator-developed task list.	Baseline, on average 4 months
Number of task list steps completed in the absence of challenging behaviors	This will be assessed using the investigator-developed task list.	Baseline, on average 4 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Jacqueline McKendry, MS BCBA LABA, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Behavior analytic research; Needle-related healthcare visits; Simulation visits; Differential reinforcement of alternative behavior (DRA)
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: H-45181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No