Clinical trial NCT05739760: Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
Official title: Cuddle-Calm Booklets - Increasing Mother-child Emotional Connection Through the Use of a Nurture-based Children's Book
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Emotional Problem
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.

Exclusion Criteria:

* Refusal to consent
* Inability to access internet; not having an email address.

Primary outcomes:
measure: Change in Tantrum Questionnaire Score
timeFrame: Change from baseline to 4 weeks post book reading
Secondary outcomes:
measure: Welch Emotional Connection Screen - Parent Report
timeFrame: change from baseline to 4 weeks post book reading
Other outcomes:
measure: Book Acceptability Questionnaire Score
timeFrame: 4 weeks after receiving designated books
Locations:
Study officials:
affiliation: Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: