Premature BirthNCT04922242
Welch Emotional Connection Screen (WECS) in the NICU
A study testing Welch Emotional Connection Screen for Neonatal Intensive Care Unit and NICU WECS Training in people with Premature Birth and Obstetric Labor, Premature, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Obstetric Labor, Premature
- What is being tested?
- Welch Emotional Connection Screen for Neonatal Intensive Care Unit and NICU WECS Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2021to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Both populations: Refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy and Validity of the Welch Emotional Connection Screen (WECS) in the NICU
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.
- Conditions
- Premature Birth, Obstetric Labor, Premature
- Being tested
- Welch Emotional Connection Screen for Neonatal Intensive Care Unit, NICU WECS Training
- Keywords
- nursing education, emotional connection
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welch Emotional Connection Screen for Neonatal Intensive Care UnitBehavioural
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.
NICU WECS TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NICU WECS Training |
| Population 2: Mother-infant dyads in NICU | Experimental | Parent and infant dyads admitted to a NICU for over 72 hours. Receives: Behavioral: Welch Emotional Connection Screen for Neonatal Intensive Care Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (5)
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.
Measured: Up to 6 months
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.
Measured: Near discharge (up to 40 weeks)
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.
Measured: Near discharge (up to 40 weeks)
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.
Measured: Near discharge (up to 40 weeks)
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'
Measured: Near discharge (up to 40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start17 Apr 2021
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional model
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Einhorn Collaborative
- Responsible party
- Sponsor
- Investigators
- Martha G. Welch, MD, Principal investigator, Professor of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922242
- Sponsor's protocol ID
- AAAT5743
- Status last verified
- Nov 2024
- First submitted
- 28 May 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Validity of the Welch Emotional Connection Screen (WECS) in the NICU
- ClinicalTrials.gov ID
- NCT04922242
- Acronym / sponsor ID
- AAAT5743
- Conditions
- Premature Birth, Obstetric Labor, Premature
- Keywords
- nursing education, emotional connection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Einhorn Collaborative
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional model
| Arm | Type | Receives |
|---|---|---|
| Population 1: NICU Study Staff | Experimental | Other: NICU WECS TrainingInterdisciplinary Professional Clinical Staff who are employed to work as a nurse, therapist, social worker or physician in the NICU. |
| Population 2: Mother-infant dyads in NICU | Experimental | Behavioral: Welch Emotional Connection Screen for Neonatal Intensive Care UnitParent and infant dyads admitted to a NICU for over 72 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Population 1: Consenting Interdisciplinary Professional Clinical Staff who are employed to work in the NICU as a:
- Population 2: Consenting parents and infants whose parents give consent by guardianship and whose physicians approve inclusion in the study.
Key exclusion criteria (1 listed)
- Both populations: Refusal to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Welch Emotional Connection Screen for Neonatal Intensive Care UnitThe 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. | Behavioural | Population 2: Mother-infant dyads in NICU |
| NICU WECS TrainingWECS 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. | Other | Population 1: NICU Study Staff |
Primary outcome
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.
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.
5 secondary outcomes
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) NICU Scores
Time frame: Up to 6 months
Correlation of WECS scores with Edinburgh Postnatal Depression Scale Score
Time frame: Near discharge (up to 40 weeks)
Correlation of WECS scores with STAI Score
Time frame: Near discharge (up to 40 weeks)
Correlation of WECS scores with CES-D
Time frame: Near discharge (up to 40 weeks)
Parent Stressor Scale (PSS): Neonatal Intensive Care Unit (NICU)
Time frame: Near discharge (up to 40 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha G. Welch, MD principal investigator
Professor of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Welch Emotional Connection Screen for Neonatal Intensive Care Unit and NICU WECS Training in people with Premature Birth and Obstetric Labor, Premature, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate of NICU WECS and WECS Training: Focus Group (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.