- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922242
Welch Emotional Connection Screen (WECS) in the NICU
Assessing the Efficacy and Validity of the Welch Emotional Connection Screen (WECS) in the NICU
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suzanne Milkiewicz-Bryjak, BSN PhD
- Phone Number: (212) 342-4400
- Email: sjb2204@cumc.columbia.edu
Study Locations
-
-
New Jersey
-
Ridgewood, New Jersey, United States, 07450
- Recruiting
- The Valley Hospital
-
Contact:
- Christiana Farkouh-Karoleski, MD
- Phone Number: 201-447-8388
- Email: FARKCH@Valleyhealth.com
-
Principal Investigator:
- Christiana Farkouh-Karoleski, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Both populations: Refusal to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
EXPERIMENTAL: Population 2: Mother-infant dyads in NICU
Parent and infant dyads admitted to a NICU for over 72 hours.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance rate of NICU WECS and WECS Training: Focus Group
Time Frame: Up to 6 months
|
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
Time Frame: Up to 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) NICU Scores
Time Frame: Up to 6 months
|
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.
|
Up to 6 months
|
Correlation of WECS scores with Edinburgh Postnatal Depression Scale Score
Time Frame: Near discharge (up to 40 weeks)
|
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.
|
Near discharge (up to 40 weeks)
|
Correlation of WECS scores with STAI Score
Time Frame: Near discharge (up to 40 weeks)
|
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.
|
Near discharge (up to 40 weeks)
|
Correlation of WECS scores with CES-D
Time Frame: Near discharge (up to 40 weeks)
|
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.
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Near discharge (up to 40 weeks)
|
Parent Stressor Scale (PSS): Neonatal Intensive Care Unit (NICU)
Time Frame: Near discharge (up to 40 weeks)
|
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'
|
Near discharge (up to 40 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of WECS scores with LOS
Time Frame: Up to 1 year
|
Correlate NICU WECS scores with quality indicators including LOS.
|
Up to 1 year
|
Correlation of WECS scores with Days on Respiratory Support
Time Frame: Up to 1 year
|
Correlate NICU WECS scores with quality indicators including days on respiratory support.
|
Up to 1 year
|
Correlation of WECS scores with Days to Full Feeds
Time Frame: Up to one year
|
Correlate NICU WECS scores with quality indicators including Days to full feeds.
|
Up to one year
|
Correlation of WECS scores with Breastfeeding Data
Time Frame: Up to 1 year
|
Correlate NICU WECS scores with quality indicators including breastfeeding data.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martha G. Welch, MD, Professor of Psychiatry
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT5743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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