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

Sponsor
Columbia University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05739760
Collaborator
(none)
0
2
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Poem book about relational health
  • Behavioral: Poem book about physical health and safety
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Cuddle-Calm Booklets - Increasing Mother-child Emotional Connection Through the Use of a Nurture-based Children's Book
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jan 21, 2022
Anticipated Study Completion Date :
Jan 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Families assigned the "Cuddle and Calm" booklet

A poem about emotional expression in times of upset

Behavioral: Poem book about relational health
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.
Other Names:
  • "Cuddle and Calm" booklet
  • Experimental: Families assigned the "Health and Safety" booklet

    A poem about health and safety with tips on topics such as first aid and injury prevention

    Behavioral: Poem book about physical health and safety
    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.
    Other Names:
  • "Health and Safety" booklet
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. Book Acceptability Questionnaire Score [4 weeks after receiving designated books]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Martha G Welch, MD, Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martha G Welch, Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology) at the Columbia University Medical Center, Columbia University
    ClinicalTrials.gov Identifier:
    NCT05739760
    Other Study ID Numbers:
    • AAAT2041
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 22, 2023