CLC Parent-Child Emotional Preparation Program

Child Development Clinical Trial

Official title:

CLC Parent-Child Emotional Preparation Program

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04626037
• Other study ID #: AAAT0109
• Status: Suspended
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: May 22, 2023

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: May 22, 2023
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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).

Related Conditions & MeSH terms

• Child Development
• Disruptive Behavior
• Emotional Connection
• Primary Prevention
• Problem Behavior

Intervention

Behavioral:
• WECS 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.

Locations

Country	Name	City	State
United States	Childcare Learning Centers of Fairfield County	Stamford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Einhorn Collaborative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Strengths and Difficulties Questionnaire (SDQ)	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).	6 weeks post-intervention; 6 months after first session
Other	Survey of Wellbeing of Young Children (SWYC) Preschool Pediatric Symptom Checklist (PPSC)	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.	6-10 weeks after intervention, and again 6 months after first session
Other	Survey of Wellbeing of Young Children (SWYC) Baby Pediatric Symptom Checklist (BPSC)	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.	6-10 weeks after intervention, and again 6 months after first session
Other	Survey of Wellbeing of Young Children (SWYC) Milestones	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.	6-10 weeks after intervention, and again 6 months after first session
Other	Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression.	6-10 weeks after intervention, and again 6 months after first session
Primary	Proportion of eligible dyads who enroll	This will be used to determine study uptake.	6 weeks
Primary	Proportion of participants who return for a second session	This will be used to determine retention rate.	6-12 weeks after first session
Secondary	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.	90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first session