What side effects are associated with this type of intervention?

Educational interventions such as online learning modules and high-fidelity simulation-based training for improving clinical skills in treating Autism Spectrum Disorder (ASD) generally do not have direct side effects. However, common treatments for ASD, such as behavioral therapies (e.g., Applied Behavior Analysis) and pharmacological treatments (e.g., antipsychotics like risperidone and aripiprazole), can have side effects. Behavioral therapies may sometimes cause stress or frustration in children due to the intensive nature of the sessions. Pharmacological treatments can have side effects including weight gain, drowsiness, and metabolic changes. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the individual needs of the patient.

What prior FDA approvals exist?

The FDA has approved certain medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD), such as risperidone and aripiprazole. These medications are primarily used to manage symptoms like aggression, self-injury, and severe tantrums. While the context does not provide specific details on FDA approvals related to educational interventions like the Online Learning Module and High-Fidelity Simulation-Based Training, these interventions are generally aimed at improving clinical skills and confidence in healthcare providers rather than directly treating ASD symptoms. Therefore, they complement pharmacological treatments by enhancing the quality of care provided to individuals with ASD.

What other types of research exist?

Promising, novel alternatives to online learning modules and high-fidelity simulation-based training for improving self-confidence and competence in clinical skills for Autism Spectrum Disorder patients include video modeling, mixed-reality simulators, and interactive computer simulations. These methods have demonstrated effectiveness in training and skill development for individuals working with ASD patients.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey

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

0 / 1Eligibility criteria met

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.