NCT03680001

Brief Summary

The purpose of this study is to assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy. The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

September 19, 2018

Last Update Submit

February 13, 2023

Conditions

Child DevelopmentPremature Birth

Keywords

emotional connectionMartha G. Welchnursing education

Outcome Measures

Primary Outcomes (1)

  • Intra-Class Correlations of Students' Welch Emotional Connection Screen (WECS) Scores

    The Welch Emotional Connection Scale (WECS) is an investigational developmental screening tool, developed to rate the quality of the emotional connection that formed between mother and child. The scale is administered in 2-3 minutes by observing a mother and child interact, and requires the rater to critically assess 4 sub-domains of emotional connection. The WECS is scored on intervals of 0.25, with a minimum of 1 (little or no connection) and maximum of 3 (high connection). High connection is considered optimal for child development, and low connection is considered a risk in child development. Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes." Observing these scores could help determine if the educational module is successful in training students to assess the emotional connection.

    2018 - 2019

Interventions

Training in Rating Emotional ConnectionBEHAVIORAL

Didactic education (video-supported educational module) on emotional connectivity will be offered to the subjects. Subjects will conference with PI to review ratings on modules.

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work

You may qualify if:

  • graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, Garland M, Glickstein SB, Brunelli SA, Ludwig RJ, Myers MM. Family Nurture Intervention in the Neonatal Intensive Care Unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. J Child Psychol Psychiatry. 2015 Nov;56(11):1202-11. doi: 10.1111/jcpp.12405. Epub 2015 Mar 11.

    PMID: 25763525BACKGROUND

  • Hane AA, LaCoursiere JN, Mitsuyama M, Wieman S, Ludwig RJ, Kwon KY, V Browne J, Austin J, M Myers M, Welch MG. The Welch Emotional Connection Screen: validation of a brief mother-infant relational health screen. Acta Paediatr. 2019 Apr;108(4):615-625. doi: 10.1111/apa.14483. Epub 2018 Aug 13.

    PMID: 29959878BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Martha G Welch, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry in Pediatrics and Pathology & Cell Biology

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

September 14, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

US(1)