NCT03680157

Brief Summary

The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points. The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

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
9 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

September 19, 2018

Last Update Submit

February 13, 2023

Conditions

Keywords

Martha G. Welchemotional connectionchild developmentpremature birth

Outcome Measures

Primary Outcomes (1)

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

    Blinded Intra-Class Correlations of WECS Scores; Clinical intra-class correlations of 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). Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes."

    2018 - 2019

Eligibility Criteria

Age4 Months - 50 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and their parents who had not participated in previously conducted studies (AAAD0389)

You may qualify if:

  • Children and their parents who participated in previously conducted studies (AAAD0389)

You may not qualify if:

  • Children and their parents who had not participated in previously conducted studies (AAAD0389)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martha Welch, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology) at the Columbia University Medical Center, Developmental Neuroscience

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

September 30, 2018

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations