An interventional study of WECS Relational Toolkit in Emotional Connection, Child Development and Primary Prevention, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
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.
517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.
This study's enrollment of 109 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Proportion of eligible dyads who enroll
This will be used to determine study uptake.
Time frame: 6 weeks
Proportion of participants who return for a second session
This will be used to determine retention rate.
Time frame: 6-12 weeks after first session
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.
Time frame: 90 minutes (post-intervention); 6-12 weeks after first session; 6 months after first session
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).
Time frame: 6 weeks post-intervention; 6 months after first session
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.
Time frame: 6-10 weeks after intervention, and again 6 months after first session
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.
Time frame: 6-10 weeks after intervention, and again 6 months after first session
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.
Time frame: 6-10 weeks after intervention, and again 6 months after first session
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.
Time frame: 6-10 weeks after intervention, and again 6 months after first session
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Columbia University