Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT03242850
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2017-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assuring Patient-centered Literacy Promotion for Underserved Children Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067010', 'term': 'Literacy'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reading Recall', 'timeFrame': 'Visit 2 (approx. 6 months)', 'description': 'Parents will report reading occurrences in a 1 week period including a 24-hour recall.'}], 'secondaryOutcomes': [{'measure': 'Survey of Wellbeing of Young Children Milestones', 'timeFrame': 'Visit 2 (approx. 6 months)', 'description': 'Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool.'}, {'measure': 'StimQ2 Read Scale / Parental Verbal Responsivity Scale', 'timeFrame': 'Visit 2 (approx. 6 months)', 'description': 'The StimQ2 is a parent reported measure of the cognitive home environment for children age 5 months to 6 years that assesses 4 domains: (1) Availability of Learning Materials (2) Reading (3) Parent Involvement in Developmental Advancement (4) Parental Verbal Responsiveness.'}, {'measure': 'Parental Reading Beliefs Inventory', 'timeFrame': 'Visit 2 (approx. 6 months)', 'description': 'Measure of parent reading beliefs'}, {'measure': 'Receipt of intervention', 'timeFrame': 'Visit 2 (approx. 6 months)', 'description': 'Parent report of receipt of guidance on shared reading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reading', 'Text Messages', 'Video', 'Cognitive Development', 'Child Development', 'Infants'], 'conditions': ['Literacy']}, 'referencesModule': {'references': [{'pmid': '33618060', 'type': 'DERIVED', 'citation': 'Jimenez ME, Crabtree BF, Hudson SV, Mendelsohn AL, Lima D, Shelton PA, Veras J, Lin Y, Pellerano M, Morrow L, Strom BL. Enhancing Reach Out and Read With a Video and Text Messages: A Randomized Trial in a Low-Income Predominantly Latino Sample. Acad Pediatr. 2021 Aug;21(6):968-976. doi: 10.1016/j.acap.2021.02.011. Epub 2021 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'This study tests whether an enhanced primary cared based literacy promotion intervention consisting of a video and text message will increase shared reading occurrences between parents and children compared to the standard version.', 'detailedDescription': 'This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced intervention consisting of a video and a series of text messages in promoting shared reading between parents and children. Participants will be randomized to one of two study arms (1) the enhanced intervention consisting of a video in the waiting room, standard guidance on shared reading, and a series of text messages (2) regular care which includes standard guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary outcomes will include receipt of intervention, measure of the cognitive home environment, developmental screening results, and measure of parent reading beliefs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. primary caregiver of a child age 6-15 months,\n2. primary language English or Spanish,\n3. cell phone ownership,\n4. age ≥18 years,\n5. willing to receive text messages, and\n6. willing to accept randomization\n\nExclusion Criteria:\n\n1. Individuals unable to provide consent\n2. Individuals who do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03242850', 'acronym': 'APLUS', 'briefTitle': 'Assuring Patient-centered Literacy Promotion for Underserved Children Study', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Assuring Patient-centered Literacy Promotion for Underserved Children to Promote School Readiness', 'orgStudyIdInfo': {'id': 'Pro20170000878'}, 'secondaryIdInfos': [{'id': '73308', 'type': 'OTHER_GRANT', 'domain': 'Robert Wood Johnson Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular care group', 'description': 'This group will receive regular care including standard guidance on shared reading. Participants in this arm will not view the video at the time of enrollment nor will they receive the text messages throughout the 6 months of the randomized controlled trial.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: Intervention Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'BEHAVIORAL', 'description': 'This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Eric B. Chandler Health Center', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Manuel E. Jimenez, MD, MS', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}