CLC Parent-Child Emotional Preparation Program

NCT04626037 | Completed

• 1 other identifier: AAAT0109
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Proportion of eligible dyads who enroll

  This will be used to determine study uptake.

  6 weeks

• Proportion of participants who return for a second session

  This will be used to determine retention rate.

  6-12 weeks after first session

Secondary Outcomes (1)

• Change in WECS screen scale score

  90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first session

Other Outcomes (5)

• Strengths and Difficulties Questionnaire (SDQ)

  6 weeks post-intervention; 6 months after first session

• Survey of Wellbeing of Young Children (SWYC) Preschool Pediatric Symptom Checklist (PPSC)

  6-10 weeks after intervention, and again 6 months after first session

• Survey of Wellbeing of Young Children (SWYC) Baby Pediatric Symptom Checklist (BPSC)

  6-10 weeks after intervention, and again 6 months after first session

Study Arms (1)

All Participants in Group Zoom Sessions

EXPERIMENTAL

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.

Behavioral: WECS Relational Toolkit

Interventions

WECS Relational Toolkit BEHAVIORAL

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.

All Participants in Group Zoom Sessions

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Einhorn Collaborative: collaborator

Study Sites (1)

Childcare Learning Centers of Fairfield County

Stamford, Connecticut, 06902, United States

Location

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Martha Welch, MD, DFAPA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: April 9, 2021
• Primary Completion: April 22, 2022
• Study Completion: November 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)