NCT04922242

Brief Summary

The purpose of this study is to assess knowledge about emotional connection, attitude about relational health, and efficacy of Welch Emotional Connection Screen (WECS) training in the NICU. The investigators seek to discern if through this didactic training, frontline NICU clinicians can be taught to reliably use the WECS to rate parent-child relational health. Additionally, the investigators seek to learn if there is construct and theoretical validity of the hospitalized infant preterm WECS by correlating WECS scores to physiological, behavioral and mental health markers for parent and infant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2023

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

May 28, 2021

Last Update Submit

November 19, 2024

Conditions

Keywords

nursing educationemotional connection

Outcome Measures

Primary Outcomes (2)

  • Acceptance rate of NICU WECS and WECS Training: Focus Group

    Assess staff opinions of NICU WECS using focus groups. Responses will be coded utilizing a grounded theory hypothesis to find thematic evidence to assess the feasibility, utility, acceptability, and efficacy of the WECS in clinical practice.

    Up to 6 months

  • Acceptance rate of NICU WECS and WECS Training: Staff Survey

    Assess staff opinions of NICU WECS using a survey. Responses will be coded utilizing a grounded theory hypothesis to find thematic evidence to assess the feasibility, utility, acceptability, and efficacy of the WECS in clinical practice.

    Up to 6 months

Secondary Outcomes (5)

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

    Up to 6 months

  • Correlation of WECS scores with Edinburgh Postnatal Depression Scale Score

    Near discharge (up to 40 weeks)

  • Correlation of WECS scores with STAI Score

    Near discharge (up to 40 weeks)

  • Correlation of WECS scores with CES-D

    Near discharge (up to 40 weeks)

  • Parent Stressor Scale (PSS): Neonatal Intensive Care Unit (NICU)

    Near discharge (up to 40 weeks)

Other Outcomes (4)

  • Correlation of WECS scores with LOS

    Up to 1 year

  • Correlation of WECS scores with Days on Respiratory Support

    Up to 1 year

  • Correlation of WECS scores with Days to Full Feeds

    Up to one year

  • +1 more other outcomes

Study Arms (2)

Population 1: NICU Study Staff

EXPERIMENTAL

Interdisciplinary Professional Clinical Staff who are employed to work as a nurse, therapist, social worker or physician in the NICU.

Other: NICU WECS Training

Population 2: Mother-infant dyads in NICU

EXPERIMENTAL

Parent and infant dyads admitted to a NICU for over 72 hours.

Behavioral: Welch Emotional Connection Screen for Neonatal Intensive Care Unit

Interventions

The Welch Emotional Connection Screen (WECS) is an investigational developmental screening tool, developed to rate the quality of the emotional connection that formed between mother and child. The screen 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 NICU WECS is a clinical tool adapted for use with neonates in the NICU. Reliability of NICU staff WECS scoring will be calculated via intra-class correlations with key scores. The WECS is scored on intervals of 0.5, with a minimum of 1 (rarely--low level of connection) and maximum of 3 (mostly--high connection). Scores are used to determine the level of need for intervention.

Population 2: Mother-infant dyads in NICU

WECS Training is an educational module consisting of an introduction of the concepts of emotional connection and autonomic co-regulation as studied by The Nurture Science Program, as well as an illustration of how these experiential constructs differ from traditional care plans that focus on educating parents to encourage "bonding" as opposed to autonomic emotional connection within the NICU. An introduction to the domains of the WECS screen as well as illustrations of these domains through video will augment the training designed for NICU staff.

Population 1: NICU Study Staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Population 1: Consenting Interdisciplinary Professional Clinical Staff who are employed to work in the NICU as a:
  • Nurse
  • Therapist
  • Social worker
  • Physician

You may not qualify if:

  • Both populations: Refusal to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Interventions

Intensive Care Units, Neonatal

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Intensive Care Units, PediatricIntensive Care UnitsHospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Martha G. Welch, MD

    Professor of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cross-sectional model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 10, 2021

Study Start

April 17, 2021

Primary Completion

February 13, 2023

Study Completion

February 13, 2023

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations