Welch Emotional Connection Screen (WECS) in the NICU

Premature Birth Clinical Trial

Official title:

Assessing the Efficacy and Validity of the Welch Emotional Connection Screen (WECS) in the NICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922242
• Other study ID #: AAAT5743
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: November 2023

Study information

• Verified date: August 2022
• Source: Columbia University
• Contact: Suzanne Milkiewicz-Bryjak, BSN PhD
• Phone: (212) 342-4400
• Email: sjb2204[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: November 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth

Intervention

Behavioral:
• Welch 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.

Other:
• NICU 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.

Locations

Country	Name	City	State
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Einhorn Collaborative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of WECS scores with LOS	Correlate NICU WECS scores with quality indicators including LOS.	Up to 1 year
Other	Correlation of WECS scores with Days on Respiratory Support	Correlate NICU WECS scores with quality indicators including days on respiratory support.	Up to 1 year
Other	Correlation of WECS scores with Days to Full Feeds	Correlate NICU WECS scores with quality indicators including Days to full feeds.	Up to one year
Other	Correlation of WECS scores with Breastfeeding Data	Correlate NICU WECS scores with quality indicators including breastfeeding data.	Up to 1 year
Primary	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
Primary	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	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.	Up to 6 months
Secondary	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.	Near discharge (up to 40 weeks)
Secondary	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.	Near discharge (up to 40 weeks)
Secondary	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.	Near discharge (up to 40 weeks)
Secondary	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'	Near discharge (up to 40 weeks)