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CompletedNCT04922242Updated Nov 21, 2024

Welch Emotional Connection Screen (WECS) in the NICU

An interventional study of Welch Emotional Connection Screen for Neonatal Intensive Care Unit and NICU WECS Training in Premature Birth and Obstetric Labor, Premature, sponsored by Columbia University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Columbia University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
193
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the detailed description

The Welch Emotional Connection Screen (WECS) is an investigational developmental screening tool that was developed to rate the quality of the emotional connection that formed between mother and child. When administered at 4 months of age, the scale has predictive value in determining which children will show higher risk for developmental problems at 18 months of age. The scale is administered in 2-3 minutes by observing a brief interaction between mother and child and requires the rater to critically assess 4 domains of emotional connection.

The present study will introduce an educational module for teaching NICU clinicians to critically observe mother-child interactions through use of a standardized didactic experience and structured use of the brief clinical screening tool, the WECS, and the theories around nurturing and emotional connection. In one module training session, participants will view a pre-recorded webinar on the WECS developed by the Nurture Science Program at Columbia University. During the second part of the training, participants will view and rate a set of pre-recorded parent-child interactions using the WECS. Clinicians will complete a survey and participate in a focus group discussion about their experiences with the training process and utility of the WECS in clinical practice. Determining if the WECS can be used easily and reliably by NICU clinicians will help to create new strategies that better meet the needs of all professionals involved in NICU care, as well as the families they serve.

02

Conditions studied

  • Premature Birth
  • Obstetric Labor, Premature

Keywords

  • nursing education
  • emotional connection
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 193 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Population 1: Consenting Interdisciplinary Professional Clinical Staff who are employed to work in the NICU as a:

    • Nurse
    • Therapist
    • Social worker
    • Physician
  • Population 2: Consenting parents and infants whose parents give consent by guardianship and whose physicians approve inclusion in the study.

Exclusion criteria

Exclusion Criteria:

  • Both populations: Refusal to consent
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
193 participants (actual)

Study arms

  • Experimental
    Population 1: NICU Study Staff

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

    Other: NICU WECS Training

  • Experimental
    Population 2: Mother-infant dyads in NICU

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

    Behavioral: Welch Emotional Connection Screen for Neonatal Intensive Care Unit

Interventions

  • BehavioralWelch Emotional Connection Screen for Neonatal Intensive Care Unit

    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.

  • OtherNICU WECS Training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

Secondary outcomes

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

    Reliability of NICU staff WECS scoring will be calculated via intra-class correlations with key scores during training, and clinically coded WECS scores will be correlated with scores generated by a Nurture Science Program staff member. 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.

    Time frame: Up to 6 months

  2. Correlation of WECS scores with Edinburgh Postnatal Depression Scale Score

    The Edinburgh Postnatal Depression Scale is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Higher scores indicate more depressive symptoms.

    Time frame: Near discharge (up to 40 weeks)

  3. Correlation of WECS scores with STAI Score

    The State-Trait Anxiety Inventory (Spielberger et al, 1983) comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety.

    Time frame: Near discharge (up to 40 weeks)

  4. Correlation of WECS scores with CES-D

    The CES-D is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression (Radloff 1977). It is the most frequently used measure in the field of infant research and maternal depression. Items probe for depressive symptoms and attitudes within the past week. Criteria are based on DSM-IV criteria for depressive disorders. A score of 16+ is traditionally used to select a depressed group. A more stringent cut-off for depression is 23+. Consistent with previous literature we will examine a low-scoring group CES-D = 0, 1, who endorse no distress.

    Time frame: Near discharge (up to 40 weeks)

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

    The PSS: NICU is a 26-item self-report measure of stress assessing three dimensions of parental experience during NICU stay: Sight and Sounds, Infant Behavior and Appearance, Parental Role Alteration. Parents are asked to rate each item on a five-point Likert scale from 'not stressful' to extremely stressful'

    Time frame: Near discharge (up to 40 weeks)

Other outcomes

  1. Correlation of WECS scores with LOS

    Correlate NICU WECS scores with quality indicators including LOS.

    Time frame: Up to 1 year

  2. Correlation of WECS scores with Days on Respiratory Support

    Correlate NICU WECS scores with quality indicators including days on respiratory support.

    Time frame: Up to 1 year

  3. Correlation of WECS scores with Days to Full Feeds

    Correlate NICU WECS scores with quality indicators including Days to full feeds.

    Time frame: Up to one year

  4. Correlation of WECS scores with Breastfeeding Data

    Correlate NICU WECS scores with quality indicators including breastfeeding data.

    Time frame: Up to 1 year

07

Study locations

1 site
  • The Valley Hospital
    Ridgewood, New Jersey 07450, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04922242
Lead sponsor
Columbia University
Collaborators
Einhorn Collaborative
Responsible party
Sponsor
First posted
Jun 10, 2021
Start date
Apr 17, 2021
Primary completion
Feb 13, 2023
Completion
Feb 13, 2023
Last update
Nov 21, 2024

Study contacts

Martha G. Welch, MD
principal investigator · Professor of Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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