Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book

Not Applicable

Withdrawn

• Conditions: Emotional Problem
• Interventions: Behavioral: Poem book about physical health and safety; Behavioral: Poem book about relational health

• Registration Number: NCT05739760
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2021-04-14
• Study Start: 2021-05
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Families assigned the "Health and Safety" booklet	Poem book about physical health and safety	A poem about health and safety with tips on topics such as first aid and injury prevention
Families assigned the "Cuddle and Calm" booklet	Poem book about relational health	A poem about emotional expression in times of upset

Primary Outcome Measures

Name	Time	Method
Change in Tantrum Questionnaire Score	Change from baseline to 4 weeks post book reading	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."

Secondary Outcome Measures

Name	Time	Method
Welch Emotional Connection Screen - Parent Report	change from baseline to 4 weeks post book reading	Test the effect of "Cuddles and Calm" on emotional connection operationalized as the Welch Emotional Connection Screen - Parent Report