Welch Emotional Connection Screen (WECS) in the NICU
Primary Purpose
Premature Birth, Obstetric Labor, Premature
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Welch Emotional Connection Screen for Neonatal Intensive Care Unit
NICU WECS Training
Sponsored by
About this trial
This is an interventional other trial for Premature Birth focused on measuring nursing education, emotional connection
Eligibility Criteria
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
Sites / Locations
- The Valley HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Population 1: NICU Study Staff
Population 2: Mother-infant dyads in NICU
Arm Description
Interdisciplinary Professional Clinical Staff who are employed to work as a nurse, therapist, social worker or physician in the NICU.
Parent and infant dyads admitted to a NICU for over 72 hours.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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'
Full Information
NCT ID
NCT04922242
First Posted
May 28, 2021
Last Updated
August 18, 2022
Sponsor
Columbia University
Collaborators
Einhorn Collaborative
1. Study Identification
Unique Protocol Identification Number
NCT04922242
Brief Title
Welch Emotional Connection Screen (WECS) in the NICU
Official Title
Assessing the Efficacy and Validity of the Welch Emotional Connection Screen (WECS) in the NICU
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Einhorn Collaborative
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Obstetric Labor, Premature
Keywords
nursing education, emotional connection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross-sectional model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Population 1: NICU Study Staff
Arm Type
Experimental
Arm Description
Interdisciplinary Professional Clinical Staff who are employed to work as a nurse, therapist, social worker or physician in the NICU.
Arm Title
Population 2: Mother-infant dyads in NICU
Arm Type
Experimental
Arm Description
Parent and infant dyads admitted to a NICU for over 72 hours.
Intervention Type
Behavioral
Intervention Name(s)
Welch Emotional Connection Screen for Neonatal Intensive Care Unit
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NICU WECS Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptance rate of NICU WECS and WECS Training: Focus Group
Description
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
Title
Acceptance rate of NICU WECS and WECS Training: Staff Survey
Description
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 Outcome Measure Information:
Title
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) NICU Scores
Description
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
Title
Correlation of WECS scores with Edinburgh Postnatal Depression Scale Score
Description
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)
Title
Correlation of WECS scores with STAI Score
Description
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)
Title
Correlation of WECS scores with CES-D
Description
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)
Title
Parent Stressor Scale (PSS): Neonatal Intensive Care Unit (NICU)
Description
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 Pre-specified Outcome Measures:
Title
Correlation of WECS scores with LOS
Description
Correlate NICU WECS scores with quality indicators including LOS.
Time Frame
Up to 1 year
Title
Correlation of WECS scores with Days on Respiratory Support
Description
Correlate NICU WECS scores with quality indicators including days on respiratory support.
Time Frame
Up to 1 year
Title
Correlation of WECS scores with Days to Full Feeds
Description
Correlate NICU WECS scores with quality indicators including Days to full feeds.
Time Frame
Up to one year
Title
Correlation of WECS scores with Breastfeeding Data
Description
Correlate NICU WECS scores with quality indicators including breastfeeding data.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Milkiewicz-Bryjak, BSN PhD
Phone
(212) 342-4400
Email
sjb2204@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha G. Welch, MD
Organizational Affiliation
Professor of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiana Farkouh-Karoleski, MD
Phone
201-447-8388
Email
FARKCH@Valleyhealth.com
First Name & Middle Initial & Last Name & Degree
Christiana Farkouh-Karoleski, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Welch Emotional Connection Screen (WECS) in the NICU
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