Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:53 AM
Study NCT ID:
NCT05739760
Status:
WITHDRAWN
Last Update Posted:
2023-02-22
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012449', 'term': 'Safety'}, {'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D000056', 'term': 'Accident Prevention'}, {'id': 'D000059', 'term': 'Accidents'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Student research, student left the university', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Book Acceptability Questionnaire Score', 'timeFrame': '4 weeks after receiving designated books', 'description': 'Assess acceptability of the poem booklets through Likert-scale questions about liking the books. This is a 11-item questionnaire with a score range of 11 to 55. 11 = low acceptability and 55 = high acceptability.'}], 'primaryOutcomes': [{'measure': 'Change in Tantrum Questionnaire Score', 'timeFrame': 'Change from baseline to 4 weeks post book reading', 'description': 'Determine whether mother-child dyads who received "Cuddle and Calm," had better scores on the tantrum questionnaire compared to the dyads who received the control book poem books, "Health and Safety."'}], 'secondaryOutcomes': [{'measure': 'Welch Emotional Connection Screen - Parent Report', 'timeFrame': 'change from baseline to 4 weeks post book reading', 'description': 'Test the effect of "Cuddles and Calm" on emotional connection operationalized as the Welch Emotional Connection Screen - Parent Report'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emotional Problem']}, 'descriptionModule': {'briefSummary': 'Children\'s social and emotional development is affected by their relationship with their parents. The goal of the study is to test an intervention that guides parents and children to strengthen their relational health and navigate difficult situations. This study will begin in the well-child visit in the pediatric department at MetroHealth Medical Center. Pediatricians will invite families to enroll in the study, then study personnel will administer two illustrated poem books called "Cuddle and Calm," a poetry book with tips on how to strengthen the parent-child relationship, or "Health and Safety," a poetry book with tips on how to avoid injuries. This intervention is based on the construct of emotional connection as studied by Martha G Welch MD, who developed the Welch Emotional Connection Screen (WECS) along with Amie Hane PhD. The WECS-Parent Report (WECS-PR) is a likert scale parent-report screen with items regarding the domains featured in the WECS.', 'detailedDescription': 'The parent-child relationship affects the child\'s socio-emotional development and the parent\'s stress. The purpose of this study is to test a behavioral intervention designed to guide parents and children on how to strengthen their relational health and navigate challenging interactions. This intervention will involve a unique experience in the well-child visit in the pediatric department (either virtually or in-person) at Metrohealth Medical Center, in which pediatricians will invite families to participate in the study. Then, study personnel will administer either "Cuddle and Calm," an illustrated poetry book that feature tips on how to promote the relationship between parents and their children, or "Health and Safety," an illustrated poetry book that features tips on how to navigate risky injuries. The approach is based on the construct of emotional connection as studied by Dr. Martha Welch\'s Nurture Science Program of Columbia University Irving Medical Center. They developed the Welch Emotional Connection Screen (WECS), an assessment that allows parent-facing professionals to rate the emotional connection of a mother-child relationship in just a few minutes of observed interaction, and shows preliminary predictive properties when performed in the first year of life. The WECS-Parent Report (WECSPR) is a Likert-scale parent-report screen with items regarding the domains featured in the WECS. All consenting subjects will complete WECS-PR, a tantrum survey before and after administration of the booklets to determine the impact of the reading material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Months', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.\n\nExclusion Criteria:\n\n* Refusal to consent\n* Inability to access internet; not having an email address.'}, 'identificationModule': {'nctId': 'NCT05739760', 'briefTitle': "Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Cuddle-Calm Booklets - Increasing Mother-child Emotional Connection Through the Use of a Nurture-based Children's Book", 'orgStudyIdInfo': {'id': 'AAAT2041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Families assigned the "Cuddle and Calm" booklet', 'description': 'A poem about emotional expression in times of upset', 'interventionNames': ['Behavioral: Poem book about relational health']}, {'type': 'EXPERIMENTAL', 'label': 'Families assigned the "Health and Safety" booklet', 'description': 'A poem about health and safety with tips on topics such as first aid and injury prevention', 'interventionNames': ['Behavioral: Poem book about physical health and safety']}], 'interventions': [{'name': 'Poem book about relational health', 'type': 'BEHAVIORAL', 'otherNames': ['"Cuddle and Calm" booklet'], 'description': "Poem book will consist of illustrations, poetry, and tips for parents on how to resolve their child's upset, their own upset, and to develop a stronger relationship. The study physician may read the book to the families at the visit. Then, families are instructed to read the book at least once, for as many times as the parent opts to.", 'armGroupLabels': ['Families assigned the "Cuddle and Calm" booklet']}, {'name': 'Poem book about physical health and safety', 'type': 'BEHAVIORAL', 'otherNames': ['"Health and Safety" booklet'], 'description': 'Poem book will consist of illustrations, poetry, and tips for parents on how to keep their child physically healthy and safe, and to avoid accidental injuries. The study physician may read the book to the families at the visit. Then families are instructed to read the book at least once, for as many times as the parent opts to.', 'armGroupLabels': ['Families assigned the "Health and Safety" booklet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martha G Welch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology) at the Columbia University Medical Center', 'investigatorFullName': 'Martha G Welch', 'investigatorAffiliation': 'Columbia University'}}}}