Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-29 @ 8:14 AM
Study NCT ID:
NCT02780557
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Parents Can Help Babies Learn to Talk With Picture Books.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in caregiver contingent talk while book reading', 'timeFrame': 'Baseline: 11 months, outcome: 15 months', 'description': 'Video recordings of dyads reading books will be analysed for quantity of caregiver contingent talk.'}], 'primaryOutcomes': [{'measure': 'Change in infant expressive vocabulary', 'timeFrame': 'Baseline: 11 months, outcome: 15 months', 'description': 'Parents will complete a standardised assessment of vocabulary, the MacArthur-Bates Communicative Development Inventory (CDI).'}], 'secondaryOutcomes': [{'measure': 'Change in caregiver reported frequency of reading', 'timeFrame': 'Baseline: 11 months, outcome: 15 months', 'description': 'Parents will complete a questionnaire about how frequently they read with their child.'}, {'measure': 'Infant Real Time Language Understanding: Accuracy', 'timeFrame': '15 months', 'description': "Infants' real-time comprehension of familiar words will be assessed at 15 months using the looking-while-listening (LWL) procedure (Fernald et al., 2008). Infants will sit in front of a computer screen with a picture on either side of it (e.g., a bottle and a shoe). We will measure the accuracy with which they look to the correct picture upon hearing a word that describes it."}, {'measure': 'Infant Real Time Language Understanding: Reaction Time', 'timeFrame': '15 months', 'description': "Infants' real-time comprehension of familiar words will be assessed at 15 months using the looking-while-listening (LWL) procedure (Fernald et al., 2008). We will measure the time it takes the child to look from a distractor to the target."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vocabulary', 'Book reading', 'Infancy', 'Parenting'], 'conditions': ['Language Development']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.', 'detailedDescription': "Children from disadvantaged families tend to have limited language skills compared to their advantaged peers. While many factors contribute to language ability, two aspects of the early caregiving environment are known to be correlated with child language outcomes 1) caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a style of communication whereby the caregiver talks about what is in their infant's current focus of attention. This style of talking can be facilitated when parents read books with their babies. The aim of this research is to establish whether asking parents to engage in contingent talk in the context of book reading promotes vocabulary learning. This study will compare the effects of an intervention to promote contingent talk against a control where parents are given books but not given any training in how to read them in a contingent manner. The study will include children from socio-economically advantaged and disadvantaged families."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '11 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInfants must be:\n\n* first born and singletons\n* full term (i.e. born no more than 3 weeks prematurely)\n* with birth weight over 2.5 kg.\n\nPrimary caregivers must:\n\n* work less than 24 hours per week (i.e., be the caregiver the child spends most time with)\n* be raising their child as monolingual English speakers.\n\nExclusion criteria:\n\nNeither caregivers nor infants must have any significant known physical, mental or learning disability.'}, 'identificationModule': {'nctId': 'NCT02780557', 'briefTitle': 'How Parents Can Help Babies Learn to Talk With Picture Books.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sheffield'}, 'officialTitle': 'A Randomised Control Trial to Test the Effect of Parent Contingent Talk During Shared Book Reading on Infant Language Learning.', 'orgStudyIdInfo': {'id': 'R/139470-11-1-INFANCY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contingent Reading Intervention', 'interventionNames': ['Behavioral: Contingent Reading Intervention']}, {'type': 'OTHER', 'label': 'Book Provision Control', 'interventionNames': ['Behavioral: Book Provision Control']}], 'interventions': [{'name': 'Contingent Reading Intervention', 'type': 'BEHAVIORAL', 'description': 'Caregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary.', 'armGroupLabels': ['Contingent Reading Intervention']}, {'name': 'Book Provision Control', 'type': 'BEHAVIORAL', 'description': 'Caregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal.', 'armGroupLabels': ['Book Provision Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2TN', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'University of Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Danielle E Matthews, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sheffield'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "With participants' permission, IPD will be archived in accordance with the guidelines of the University of Sheffield, the UK Data Archive and the ESRC's Research Data Policy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sheffield', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reader in Cognitive Development', 'investigatorFullName': 'Danielle Matthews', 'investigatorAffiliation': 'University of Sheffield'}}}}