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Simulation-Based Training for Autism

N/A
Recruiting
Led By Kevin Ching
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
[Primary study participants] Nurses and medical assistants employed in the pediatric clinics of HT3 and HT5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey
Awards & highlights

Study Summary

This trial is studying an online learning module combined with high fidelity simulation-based training to see if it improves medical assistants' and registered nurses' self-confidence and competence scores in taking vital signs in a child with Autism Spectrum Disorder in clinic.

Who is the study for?
This trial is for nurses and medical assistants at pediatric clinics HT3 and HT5, aiming to improve their skills in taking vital signs from children with Autism Spectrum Disorder. Children aged 1-17 with autism who visit these clinics are also part of the study if accompanied by an English-literate guardian.Check my eligibility
What is being tested?
The trial tests whether an online educational module plus simulation-based training boosts confidence and competence in healthcare workers when measuring vitals of autistic children. It will check if this method translates into better clinical practice.See study design
What are the potential side effects?
Since this intervention involves education and training without direct medical treatments or drugs, there are no typical side effects associated with it. However, participants may experience stress or anxiety related to learning new techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a nurse or medical assistant working in pediatric clinics at HT3 or HT5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in competency scores on the employee questionnaire at weeks 10 and 16
Mean change from baseline in confidence scores on the employee questionnaire at weeks 10 and 16
Secondary outcome measures
Mean change from baseline in caregiver satisfaction score on the caregiver survey between weeks 6-10 and 12-16
Mean change from baseline in knowledge scores on the employee questionnaire at weeks 10 and 16
Mean change in the number of times vital signs obtained between weeks 0-4, weeks 6-10, and weeks 12-16

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Educational Intervention: online didactic lecture and educational simulation activityExperimental Treatment1 Intervention
The didactic was created by the research team and provides information on Autism Spectrum Disorder (ASD) and an approach to taking vital signs in these children. The didactic will be pre-recorded and sent by email to employee study participants. The didactic will last about 10 minutes. The simulation activity will have the premise of a child with ASD and their caregiver at clinic visit. The employee participant will be asked to take vital signs on the patient. The caregiver will be played by an actor and the child will be played by a mannequin. An iterative script will be used by the actor during the scenario. The simulation will last about 20 minutes and will be followed by a 10 minute debrief.
Group II: Caregiver SatisfactionActive Control1 Intervention
Caregivers who accompany their children with autism to the clinic will be surveyed for their comfort scores before and after the study participants' educational intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS program. These treatments work by improving social communication, adaptive behaviors, and cognitive functions through structured, repetitive activities and positive reinforcement. The mechanisms of action involve enhancing joint attention, symbolic play, and emotional regulation, which are critical for the development of social and communication skills. For ASD patients, these mechanisms are vital as they address core deficits and improve overall functioning and independence. Educational interventions like the Online Learning Module and High-Fidelity Simulation-Based Training aim to increase the competence and confidence of caregivers and healthcare providers, ensuring that they can effectively support the developmental needs of children with ASD.
Through the Looking Glass: A Scoping Review of Cinema and Video Therapy.Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment-Autism (PAT-A©) pilot randomised controlled feasibility trial.RELATE-a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations: a study protocol.

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,063 Previous Clinical Trials
1,319,140 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
11,311 Patients Enrolled for Autism Spectrum Disorder
Kevin ChingPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Educational Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05288868 — N/A
Educational Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288868 — N/A
Autism Spectrum Disorder Research Study Groups: Educational Intervention: online didactic lecture and educational simulation activity, Caregiver Satisfaction
Autism Spectrum Disorder Clinical Trial 2023: Educational Intervention Highlights & Side Effects. Trial Name: NCT05288868 — N/A
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT05288868 — N/A
~0 spots leftby Jun 2024