Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06312358
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanding the Infant Achievements Intervention Through Community Partnerships
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057191', 'term': 'Capacity Building'}, {'id': 'D002654', 'term': 'Child Care'}], 'ancestors': [{'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D000096763', 'term': 'Pandemic Preparedness'}, {'id': 'D004189', 'term': 'Disaster Planning'}, {'id': 'D004190', 'term': 'Disasters'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D006296', 'term': 'Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will be assigned to the study intervention consisting of (1) a professional development workshop and (2) weekly job-embedded coaching sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-09', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classroom Quality (as assessed by scores on the TPITOS)', 'timeFrame': 'Change from baseline/pretest up to posttest, up to 16 weeks.', 'description': "Classroom quality will be measured by total scores (ranging from 0-100%) on the Teaching Pyramid Model Infant-Toddler Observation Scale (TPITOS) which assesses the extent to which an early childhood program's staff is fostering responsive, nurturing relationships with young children and promoting strong social-emotional development."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teacher Training', 'Mentoring', 'Inservice Training'], 'conditions': ['Child Development', 'Infant Development', 'Developmental Delay', 'Language Development']}, 'descriptionModule': {'briefSummary': "The goal of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. The main questions that the study aims to answer are:\n\n1. Does teacher participation in a PD intervention improve the use of evidence-based practices from pre- to posttest?\n2. To what extent is the PD intervention feasible to implement in an established child care program?\n3. To what extent is the PD program acceptable to teachers?\n\nParticipants will attend PD workshops and participate in content-related job-embedded coaching sessions during the implementation of the study.", 'detailedDescription': "The primary objective of the research study is to increase teachers' implementation of evidence-based practices in Early Head Start classrooms through the delivery of a professional development (PD) training intervention. It is hypothesized that teachers' fidelity to developmentally-appropriate practices, assessed through classroom observation measures, will increase following their participation in a comprehensive PD training intervention. The secondary hypotheses are that (1) the PD intervention is feasible to implement in an established child care program, and (2) the PD program is acceptable to teachers. Teacher participants will attend PD workshops, co-developed with community partners, and engage in follow-up job-embedded coaching sessions occurring weekly in their classrooms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must currently work in an early childhood classroom serving children between 8-36 months of age.\n* Participants must work in the role of a teacher or teacher assistant in an Early Head Start location.\n* Participants must be willing to participate in two 60-90-minute trainings/workshops.\n* Participants must be willing to participate in eight follow-up job-embedded coaching sessions\n\nExclusion Criteria:\n\n* Works in a childcare setting outside of the Baltimore metro area\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT06312358', 'briefTitle': 'Expanding the Infant Achievements Intervention Through Community Partnerships', 'organization': {'class': 'OTHER', 'fullName': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}, 'officialTitle': 'Centering Community Partnerships to Facilitate Scaling Up of Infant Achievements for Community Implementation', 'orgStudyIdInfo': {'id': 'IRB00408654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teacher Professional Development Workshop and Coaching', 'description': "Teachers will participate in a professional development workshop session (approximately 2 hours in duration) followed by 8 weekly coaching sessions (approximately 45-60 minutes in duration). The study team (trained coaches) will utilize the Practice-Based Coaching model (Snyder et al., 2015) to support teachers' use of developmentally appropriate practices in early childhood classrooms. Teachers will be coached to implement strategies that foster responsive and nurturing relationships with young children.", 'interventionNames': ['Behavioral: Building Capacity for Infant Achievements in Child Care']}], 'interventions': [{'name': 'Building Capacity for Infant Achievements in Child Care', 'type': 'BEHAVIORAL', 'description': 'All teacher participants will be assigned to the professional development intervention consisting of an interactive workshop and weekly coaching sessions.', 'armGroupLabels': ['Teacher Professional Development Workshop and Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21211', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Rebecca Landa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kennedy Krieger Institute, Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President, Professor', 'investigatorFullName': 'Rebecca Landa', 'investigatorAffiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}}}}