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CLC Parent-Child Emotional Preparation Program

Primary Purpose

Emotional Connection, Child Development, Primary Prevention

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WECS Relational Toolkit
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emotional Connection focused on measuring Welch Emotional Connection Screen (WECS) Toolkit, Nurture Science Program's (NSP), Children's Learning Centers (CLC), Parent-Child Emotional Preparation for Preschool

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Preschool aged children from 0-5 years old and their mothers in CLC programs.

Exclusion Criteria:

- Families that choose not to participate in any data collection procedures but would like to listen in on the session(s).

Sites / Locations

  • Childcare Learning Centers of Fairfield County

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants in Group Zoom Sessions

Arm Description

During each session, the mother-child dyads will meet with Nurture Science program staff virtually. The entire procedure will be done on Zoom or in person depending on school opening. All mother-child pairs will then be asked to interact, with the child sitting on the mother's lap face-to-face. The rest of the session may continue with: (1) Reading Cuddle and Calm Book (2) Mutual Mother and Child Emotional Exchange Prompts (3) Mothers Support Circle to identify and engage members of the mother's family in helping the dyad with emotional connection (4) Mommy Baby Book (5) Bottle of Emotions (6) Plans for continuing the work in the family. Returning mothers will be asked how they have progressed using the Cuddle and Calm and mutual narrative over the week and what their experience with their child after the session has been.

Outcomes

Primary Outcome Measures

Proportion of eligible dyads who enroll
This will be used to determine study uptake.
Proportion of participants who return for a second session
This will be used to determine retention rate.

Secondary Outcome Measures

Change in WECS screen scale score
Emotional connection will be measured from pre- and post-intervention WECS screen scale scores will be compared using paired sample t-tests. Change in WECS scores will be correlated with attendance using Spearman's rank correlation coefficient. This is a clinical tool completed by study staff to assess the emotional connection of a mother-child dyad. The WECS focuses on specific domains: attraction, vocal communication, facial communication, sensitivity/responsivity and one general: a dyad's interventional need. The WECS is scored based on observed presence of these 4 domains. The lowest score being a 1 and the highest being a 3. The higher the score, the more emotionally connected the dyad is therefore indicating a better outcome.

Full Information

First Posted
November 10, 2020
Last Updated
February 14, 2023
Sponsor
Columbia University
Collaborators
Einhorn Collaborative
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1. Study Identification

Unique Protocol Identification Number
NCT04626037
Brief Title
CLC Parent-Child Emotional Preparation Program
Official Title
CLC Parent-Child Emotional Preparation Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
The new director of the program temporarily stopped the study.
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
May 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Einhorn Collaborative

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the feasibility of the Nurture Science Program's (NSP) Drop-In group via telemedicine as standard care at Children's Learning Centers (CLC) to prepare preschoolers emotionally for the preschool experience utilizing the Welch Emotional Connection Screen (WECS) Relational Health Toolkit. The behavioral, neurobiological, and clinical insights gained from this project may lead to better treatment of emotional, behavioral and developmental disorders.
Detailed Description
The purpose of this study is to test the practicality of mothers and children utilizing the WECS Relational Health Toolkit. The Cuddle and Calm Book, Well Baby Book, mother and child mutual narrative activity card, Bottle of Feelings, Mother's Socioemotional Support Circle, and the WECS for emotional connection make up the preschool WECS Relational Health toolkit. The WECS Relational Health Toolkit provides family-based resources to help mothers and children emotionally connect. The WECS Relational Health Toolkit is designed to create emotional connection and establish mother-child autonomic co-regulation, which helps shape autonomic state and behavior of the mother and child and therefore determines early child development and mother well-being. The investigators will test whether this toolkit can be a positive part of a standard preschool education program. Practicality will be measured through virtual participant attendance, a participant survey, and staff notes. Effects of this program on the emotional connection of mother-child pair will be measured through the Welch Emotional Connection Screen (WECS). Effects on child behaviors will be measured through the WECS-Parent Report (WECS-PR), SDQ, and Survey of Wellbeing of Young Children Baby Pediatric Symptom Checklist (BPSC) or the Preschool Pediatric Symptom Checklist (PPSC) subscales (age-dependent). We will also measure symptoms of depression in the mothers using the Center for Epidemiological Studies-Depression (CES-D) before and after the introduction to the Toolkit. We will also assess differences in developmental progress using the Milestones subscale of the SWYC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Connection, Child Development, Primary Prevention, Disruptive Behavior
Keywords
Welch Emotional Connection Screen (WECS) Toolkit, Nurture Science Program's (NSP), Children's Learning Centers (CLC), Parent-Child Emotional Preparation for Preschool

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Using a pre-test, post-test design, this study will be comprised of a single group in which all participants are offered two Drop-In Zoom group sessions during the school semester. Exposure will vary at participant discretion.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Participants in Group Zoom Sessions
Arm Type
Experimental
Arm Description
During each session, the mother-child dyads will meet with Nurture Science program staff virtually. The entire procedure will be done on Zoom or in person depending on school opening. All mother-child pairs will then be asked to interact, with the child sitting on the mother's lap face-to-face. The rest of the session may continue with: (1) Reading Cuddle and Calm Book (2) Mutual Mother and Child Emotional Exchange Prompts (3) Mothers Support Circle to identify and engage members of the mother's family in helping the dyad with emotional connection (4) Mommy Baby Book (5) Bottle of Emotions (6) Plans for continuing the work in the family. Returning mothers will be asked how they have progressed using the Cuddle and Calm and mutual narrative over the week and what their experience with their child after the session has been.
Intervention Type
Behavioral
Intervention Name(s)
WECS Relational Toolkit
Intervention Description
The Cuddle and Calm Book, The Mommy Baby Book, mother and child mutual narrative, the Bottle of Emotions, and the WECS for emotional connection, make up the WECS Relational Health toolkit.
Primary Outcome Measure Information:
Title
Proportion of eligible dyads who enroll
Description
This will be used to determine study uptake.
Time Frame
6 weeks
Title
Proportion of participants who return for a second session
Description
This will be used to determine retention rate.
Time Frame
6-12 weeks after first session
Secondary Outcome Measure Information:
Title
Change in WECS screen scale score
Description
Emotional connection will be measured from pre- and post-intervention WECS screen scale scores will be compared using paired sample t-tests. Change in WECS scores will be correlated with attendance using Spearman's rank correlation coefficient. This is a clinical tool completed by study staff to assess the emotional connection of a mother-child dyad. The WECS focuses on specific domains: attraction, vocal communication, facial communication, sensitivity/responsivity and one general: a dyad's interventional need. The WECS is scored based on observed presence of these 4 domains. The lowest score being a 1 and the highest being a 3. The higher the score, the more emotionally connected the dyad is therefore indicating a better outcome.
Time Frame
90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first session
Other Pre-specified Outcome Measures:
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds. It exists in several versions to meet the needs of researchers, clinicians and educationalists. All versions of the SDQ ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: (1) emotional symptoms (5 items); (2) conduct problems (5 items); (3) hyperactivity/inattention (5 items); (4) peer relationship problems (5 items); (5) prosocial behavior (5 items). Sections (1) to (4) are added together to generate a total difficulties score (based on 20 items), ranging from 0 (better outcome) to 40 (worse outcome).
Time Frame
6 weeks post-intervention; 6 months after first session
Title
Survey of Wellbeing of Young Children (SWYC) Preschool Pediatric Symptom Checklist (PPSC)
Description
The SWYC is a screening instrument for children up to 5 years of age. The Preschool Pediatric Symptom Checklist (PPSC) is used for children 18 months or older. Higher scores indicate higher risk.
Time Frame
6-10 weeks after intervention, and again 6 months after first session
Title
Survey of Wellbeing of Young Children (SWYC) Baby Pediatric Symptom Checklist (BPSC)
Description
The SWYC is a screening instrument for children up to 5 years of age. The Baby Pediatric Symptom Checklist (BPSC) is used for children under 18 months. Higher scores indicate higher risk.
Time Frame
6-10 weeks after intervention, and again 6 months after first session
Title
Survey of Wellbeing of Young Children (SWYC) Milestones
Description
The SWYC is a screening instrument for children up to 5 years of age. The Developmental Milestones (DM) of the SWYC will be used. Lower scores indicate higher risk.
Time Frame
6-10 weeks after intervention, and again 6 months after first session
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression.
Time Frame
6-10 weeks after intervention, and again 6 months after first session

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Preschool aged children from 0-5 years old and their mothers in CLC programs. Exclusion Criteria: - Families that choose not to participate in any data collection procedures but would like to listen in on the session(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Welch, MD, DFAPA
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childcare Learning Centers of Fairfield County
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CLC Parent-Child Emotional Preparation Program

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