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NCT Number: NCT06712784

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

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.

Recruiting

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Jacqueline McKendry, MS BCBA LABA

CONTACT

[email protected]

617-414-3874

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Jacqueline McKendry, MS BCBA LABA

CONTACT

[email protected]

617 414 3874

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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