Clinical trial NCT06712784: Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients
Official title: Supporting Patients With Autism Spectrum Disorder (ASD) During Needle-related Hospital Visits Through the Use of Behavior Analytic Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Behavior analytic research
Needle-related healthcare visits
Simulation visits
Differential reinforcement of alternative behavior (DRA)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of participants who have a decrease in challenging behaviors in the presence of medical stimuli (needles)
timeFrame: Baseline, on average 4 months
measure: Number of task list steps completed in the absence of challenging behaviors
timeFrame: Baseline, on average 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jacqueline McKendry, MS BCBA LABA
role: PRINCIPAL_INVESTIGATOR
References: