Emotional ProblemNCT05739760
Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
A study testing Poem book about relational health and Poem book about physical health and safety in people with Emotional Problem, run by Columbia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Emotional Problem
- What is being tested?
- Poem book about relational health and Poem book about physical health and safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.
Who cannot join
- Refusal to consent
- Inability to access internet; not having an email address.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emotional Problem
- Being tested
- Poem book about relational health, Poem book about physical health and safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poem book about relational healthBehavioural
Also called "Cuddle and Calm" booklet
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.
Poem book about physical health and safetyBehavioural
Also called "Health and Safety" booklet
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.
| Study group | Role | What they receive |
|---|---|---|
| Families assigned the "Cuddle and Calm" booklet | Experimental | A poem about emotional expression in times of upset Receives: Behavioral: Poem book about relational health |
| Families assigned the "Health and Safety" booklet | Experimental | A poem about health and safety with tips on topics such as first aid and injury prevention Receives: Behavioral: Poem book about physical health and safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tantrum Questionnaire Score
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."
Measured: Change from baseline to 4 weeks post book reading
Secondary outcomes (1)
Welch Emotional Connection Screen - Parent Report
Test the effect of "Cuddles and Calm" on emotional connection operationalized as the Welch Emotional Connection Screen - Parent Report
Measured: change from baseline to 4 weeks post book reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startMay 2021 (estimated)
- Primary completion21 Jan 2022 (estimated)
- Study completion21 Jan 2022 (estimated)
Why it stopped: Student research, student left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProblemStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha G Welch, Columbia University
- Investigators
- Martha G Welch, MD, Principal investigator, Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739760
- Sponsor's protocol ID
- AAAT2041
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cuddle-Calm Booklets - Increasing Mother-child Emotional Connection Through the Use of a Nurture-based Children's Book
- ClinicalTrials.gov ID
- NCT05739760
- Acronym / sponsor ID
- AAAT2041
- Conditions
- Emotional Problem
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Student research, student left the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- 21 Jan 2022 (estimated)
- Study completion
- 21 Jan 2022 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Families assigned the "Cuddle and Calm" booklet | Experimental | Behavioral: Poem book about relational healthA poem about emotional expression in times of upset |
| Families assigned the "Health and Safety" booklet | Experimental | Behavioral: Poem book about physical health and safetyA poem about health and safety with tips on topics such as first aid and injury prevention |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.
Key exclusion criteria (2 listed)
- Refusal to consent
- Inability to access internet; not having an email address.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poem book about relational healthAlso: "Cuddle and Calm" bookletPoem 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. | Behavioural | Families assigned the "Cuddle and Calm" booklet |
| Poem book about physical health and safetyAlso: "Health and Safety" bookletPoem 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. | Behavioural | Families assigned the "Health and Safety" booklet |
Primary outcome
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."
1 secondary outcome
Welch Emotional Connection Screen - Parent Report
Time frame: change from baseline to 4 weeks post book reading
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha G Welch, MD principal investigator
Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Questions about this trial
What is this clinical trial studying?
A study testing Poem book about relational health and Poem book about physical health and safety in people with Emotional Problem, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tantrum Questionnaire Score (time frame: Change from baseline to 4 weeks post book reading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.