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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06273618
Other study ID # iLO-ML-23396
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2024
Est. completion date February 2027

Study information

Verified date May 2024
Source Milton S. Hershey Medical Center
Contact Benjamin H Levi, MD PhD
Phone 717-531-8778
Email BHLevi@psu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs.


Description:

The primary purpose of this study is to understand the optimal timing to administer iLookOut Micro-Learning to boost ECPs waning knowledge and preparedness to protect children from abuse. Additionally, this study will conduct a randomized controlled trial to examine how interactive, gamified micro-learning promotes knowledge retention and fosters behavior change with regard to child abuse and its reporting, and to establish that implementation of this intervention is feasible. All components of the learning module being studied are online, and will be accessed by participants through a secure website. Once they complete the Core Training, participants who identify as ECPs will receive an email indicating which randomization arm they are in (regarding access to the advanced training) - immediate, 3 months, 6 months, or 9 months. Non-ECPs will be able to complete the advanced training as soon as they complete the Core Training. All non-ECPs will be used as a comparison group to determine if the iLookOut trainings are effective for improving and retaining knowledge, and changing behavior among Non-ECPs compared to the ECP participants. Separate mixed-effects linear regression model will be applied to assess (1) the knowledge decay effect based on the data collected at different time-points and (2) the behavior change between the various time-points and how it is correlated to the knowledge score, after controlling for participants' baseline characteristics and work setting. In addition, the regression model will adjust effects for allocation blocks and the factors for stratification in the analysis to reduce group variability.


Recruitment information / eligibility

Status Recruiting
Enrollment 12000
Est. completion date February 2027
Est. primary completion date February 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older Exclusion Criteria: - Younger than 18 years of age

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Micro-Learning
Micro-Learning involves a series of 5-10 minute interactive, gamified learning exercises delivered to smart-phones (or computers) to reinforce and augment knowledge and promote attitudes and behavior to promote children's wellbeing.

Locations

Country Name City State
United States Penn State College of Medicine Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test Validated knowledge test regarding child maltreatment and its reporting 3 months
Primary Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire Self-report questionnaire of behavior regarding child maltreatment and its reporting 3 months
Secondary Comparison of early childhood professionals vs. non-early childhood professionals Comparison knowledge and behavioral outcomes for early childhood professionals vs. non-early childhood professionals 6 months
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