- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739760
Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
February 13, 2023 updated by: Martha G Welch, Columbia University
Cuddle-Calm Booklets - Increasing Mother-child Emotional Connection Through the Use of a Nurture-based Children's Book
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Families assigned the "Cuddle and Calm" booklet
A poem about emotional expression in times of upset
|
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:
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tantrum Questionnaire Score
Time Frame: 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."
|
Change from baseline to 4 weeks post book reading
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Welch Emotional Connection Screen - Parent Report
Time Frame: 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
|
change from baseline to 4 weeks post book reading
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Book Acceptability Questionnaire Score
Time Frame: 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.
|
4 weeks after receiving designated books
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martha G Welch, MD, Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
January 21, 2022
Study Completion (Anticipated)
January 21, 2022
Study Registration Dates
First Submitted
April 14, 2021
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Estimate)
February 22, 2023
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AAAT2041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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