Clinical trial NCT04626037: CLC Parent-Child Emotional Preparation Program
Official title: CLC Parent-Child Emotional Preparation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Einhorn Collaborative
First posted: 2020-11-12
Enrollment: 109
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Proportion of eligible dyads who enroll
timeFrame: 6 weeks
measure: Proportion of participants who return for a second session
timeFrame: 6-12 weeks after first session
Secondary outcomes:
measure: Change in WECS screen scale score
timeFrame: 90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first session
Other outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 6 weeks post-intervention; 6 months after first session
measure: Survey of Wellbeing of Young Children (SWYC) Preschool Pediatric Symptom Checklist (PPSC)
timeFrame: 6-10 weeks after intervention, and again 6 months after first session
measure: Survey of Wellbeing of Young Children (SWYC) Baby Pediatric Symptom Checklist (BPSC)
timeFrame: 6-10 weeks after intervention, and again 6 months after first session
measure: Survey of Wellbeing of Young Children (SWYC) Milestones
timeFrame: 6-10 weeks after intervention, and again 6 months after first session
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6-10 weeks after intervention, and again 6 months after first session
Locations:
city: Stamford
country: United States
facility: Childcare Learning Centers of Fairfield County
state: Connecticut
Study officials:
affiliation: Columbia University
name: Martha Welch, MD, DFAPA
role: PRINCIPAL_INVESTIGATOR
References: