Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06273618
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2023-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
iLookOut Micro-learning to Improve Knowledge Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Early Childhood Professionals (ECPs) will be randomized to 1 of 4 groups, which will differ in terms of when they receive access to Micro-Learning. Non-ECPs will constitute a separate group, which will receive access to Micro-Learning immediately upon completing the Core Training.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test', 'timeFrame': '3 months', 'description': 'Validated knowledge test regarding child maltreatment and its reporting'}, {'measure': 'Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire', 'timeFrame': '3 months', 'description': 'Self-report questionnaire of behavior regarding child maltreatment and its reporting'}], 'secondaryOutcomes': [{'measure': 'Comparison of early childhood professionals vs. non-early childhood professionals', 'timeFrame': '6 months', 'description': 'Comparison knowledge and behavioral outcomes for early childhood professionals vs. non-early childhood professionals'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child maltreatment', 'suspicion of abuse', 'knowledge', 'attitudes', 'behavior'], 'conditions': ['Knowledge', 'Attitudes', 'Practice']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nAll components of the learning module being studied are online, and will be accessed by participants through a secure website.\n\nOnce 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.\n\nSeparate 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT06273618', 'briefTitle': 'iLookOut Micro-learning to Improve Knowledge Retention', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'iLookOut for Child Abuse: PA Microlearning to Improve Knowledge Retention', 'orgStudyIdInfo': {'id': 'iLO-ML-23396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate', 'description': 'ECP participants who receive access to the Micro-Learning intervention immediately upon completing the Core Training.', 'interventionNames': ['Other: Micro-Learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3-month', 'description': 'ECP participants who receive access to the Micro-Learning intervention 3 months after upon completing the Core Training.', 'interventionNames': ['Other: Micro-Learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6-month', 'description': 'ECP participants who receive access to the Micro-Learning intervention 6 months after upon completing the Core Training.', 'interventionNames': ['Other: Micro-Learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': '9-month', 'description': 'ECP participants who receive access to the Micro-Learning intervention 9 months after upon completing the Core Training.', 'interventionNames': ['Other: Micro-Learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-ECPs', 'description': 'Non-ECP participants', 'interventionNames': ['Other: Micro-Learning']}], 'interventions': [{'name': 'Micro-Learning', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['3-month', '6-month', '9-month', 'Immediate', 'Non-ECPs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin H Levi, MD, PhD', 'role': 'CONTACT', 'email': 'BHLEVI@psu.edu', 'phone': '717-531-8778'}, {'name': 'Nicole R Verdiglione, BA', 'role': 'CONTACT', 'email': 'nverdiglione@pennstatehealth.psu.edu', 'phone': '717-531-0003', 'phoneExt': '283765'}], 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'centralContacts': [{'name': 'Benjamin H Levi, MD PhD', 'role': 'CONTACT', 'email': 'BHLevi@psu.edu', 'phone': '717-531-8778'}, {'name': 'Nicole Verdiglione, MA', 'role': 'CONTACT', 'email': 'nverdiglione@pennstatehealth.psu.edu', 'phone': '717-531-8778'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators will make available de-identified study data for the primary and secondary outcomes for authorized research projects upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin H. Levi', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}