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

NCT06712784 | Recruiting

• 1 other identifier: H-45181
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Behavior analytic research; Needle-related healthcare visits; Simulation visits; Differential reinforcement of alternative behavior (DRA)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Behavioral: Treatment Package (for both simulation and procedure sessions

Interventions

Treatment Package (for both simulation and procedure sessions BEHAVIORAL

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).

Treatment Packet

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jacqueline McKendry, MS BCBA LABA

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline McKendry, MS BCBA LABA

CONTACT

617 414 3874; jacqueline.mckendry@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)