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CLC Parent-Child Emotional Preparation Program

CLC Parent-Child Emotional Preparation Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04626037
Enrollment
109
Registered
2020-11-12
Start date
2021-04-09
Completion date
2023-11-01
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Disruptive Behavior, Emotional Connection, Primary Prevention

Keywords

Welch Emotional Connection Screen (WECS) Toolkit, Nurture Science Program's (NSP), Children's Learning Centers (CLC), Parent-Child Emotional Preparation for Preschool

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.

Interventions

BEHAVIORALWECS Relational Toolkit

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.

Sponsors

Einhorn Collaborative
CollaboratorUNKNOWN
Columbia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Proportion of eligible dyads who enroll6 weeksThis will be used to determine study uptake.
Proportion of participants who return for a second session6-12 weeks after first sessionThis will be used to determine retention rate.

Secondary

MeasureTime frameDescription
Change in WECS screen scale score90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first sessionEmotional 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.

Other

MeasureTime frameDescription
Survey of Wellbeing of Young Children (SWYC) Milestones6-10 weeks after intervention, and again 6 months after first sessionThe 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.
Strengths and Difficulties Questionnaire (SDQ)6 weeks post-intervention; 6 months after first sessionThe 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).
Center for Epidemiologic Studies Depression Scale (CES-D)6-10 weeks after intervention, and again 6 months after first sessionThe CES-D is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression.
Survey of Wellbeing of Young Children (SWYC) Preschool Pediatric Symptom Checklist (PPSC)6-10 weeks after intervention, and again 6 months after first sessionThe 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.
Survey of Wellbeing of Young Children (SWYC) Baby Pediatric Symptom Checklist (BPSC)6-10 weeks after intervention, and again 6 months after first sessionThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026