Child DevelopmentNCT03680157
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
An observational study of Child Development and Premature Birth, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points. Read more about this study
- Who is it for?
- Ages 4 months to 50 years
- Conditions the study is for
- Child Development, Premature Birth
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 23 Aug 2019
- Phase
- Observational
- 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 4 months to 50 years
- All sexes
- Child, Adult
Study population: Children and their parents who had not participated in previously conducted studies (AAAD0389)
Who may be able to join
- Children and their parents who participated in previously conducted studies (AAAD0389)
Who cannot join
- Children and their parents who had not participated in previously conducted studies (AAAD0389)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points.
The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.
Read the detailed description
The purpose of this study is to determine the external validity of a scale for emotional connection between children and their parents through a retrospective longitudinal study. The Welch Emotional Connection Scale (WECS) is a screen that allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed interaction, and shows preliminary predictive properties when performed in the first year of the child's life. Administration of the WECS involves watching interactions of a child sitting face-to-face on a parent's lap, and scores the interaction on sliding scales in 4 domains. During the WECS development, the Nurture Science Program of Columbia University Medical Center created and coded hours of parent-child interaction videos. This video data set will be used to determine how clinical WECS scores, where raters are familiar with mother-child dyads over time, compare to research WECS scores, where rate-rs are blinded to each case. The WECS scores of clinical coders, who are exposed to the same case at different time points, will be compared to blinded coders who see cases at just one time point. To simulate implementation of the WECS in a clinical setting, two primary care nurse practitioner (PNP) students who are trained in rating emotional connection will view videos to rate the emotional connection of mother-child dyads collected at different time points. To recreate WECS used in a research setting, blinded coders trained in rating emotional connection will rate the emotional connection of the same video data set. Each blinded coder will only view a dyad once, to not be influenced by previous time points of the same subject. The inter-rater reliability of the blinded and clinical coders will be determined. The comparison of inter-rater reliability scores between clinical and blinded coders is the main outcome of this study.
- Conditions
- Child Development, Premature Birth
- Keywords
- Martha G. Welch, emotional connection, child development, premature birth
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) Scores
Blinded Intra-Class Correlations of WECS Scores; Clinical intra-class correlations of WECS Scores. The Welch Emotional Connection Scale (WECS) is an investigational developmental screening tool, developed to rate the quality of the emotional connection that formed between mother and child. The scale 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 WECS is scored on intervals of 0.25, with a minimum of 1 (little or no connection) and maximum of 3 (high connection). Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes."
Measured: 2018 - 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start30 Sep 2018
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha G Welch, Columbia University
- Investigators
- Martha Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680157
- Sponsor's protocol ID
- AAAS0811
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2018
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
- ClinicalTrials.gov ID
- NCT03680157
- Acronym / sponsor ID
- AAAS0811
- Conditions
- Child Development, Premature Birth
- Keywords
- Martha G. Welch, emotional connection, child development, premature birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 21 Sep 2018 (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 determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points.
The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.
Detailed description
The purpose of this study is to determine the external validity of a scale for emotional connection between children and their parents through a retrospective longitudinal study. The Welch Emotional Connection Scale (WECS) is a screen that allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed interaction, and shows preliminary predictive properties when performed in the first year of the child's life. Administration of the WECS involves watching interactions of a child sitting face-to-face on a parent's lap, and scores the interaction on sliding scales in 4 domains. During the WECS development, the Nurture Science Program of Columbia University Medical Center created and coded hours of parent-child interaction videos. This video data set will be used to determine how clinical WECS scores, where raters are familiar with mother-child dyads over time, compare to research WECS scores, where rate-rs are blinded to each case. The WECS scores of clinical coders, who are exposed to the same case at different time points, will be compared to blinded coders who see cases at just one time point. To simulate implementation of the WECS in a clinical setting, two primary care nurse practitioner (PNP) students who are trained in rating emotional connection will view videos to rate the emotional connection of mother-child dyads collected at different time points. To recreate WECS used in a research setting, blinded coders trained in rating emotional connection will rate the emotional connection of the same video data set. Each blinded coder will only view a dyad once, to not be influenced by previous time points of the same subject. The inter-rater reliability of the blinded and clinical coders will be determined. The comparison of inter-rater reliability scores between clinical and blinded coders is the main outcome of this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 months to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and their parents who had not participated in previously conducted studies (AAAD0389)
Key inclusion criteria (1 listed)
- Children and their parents who participated in previously conducted studies (AAAD0389)
Key exclusion criteria (1 listed)
- Children and their parents who had not participated in previously conducted studies (AAAD0389)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) Scores
Time frame: 2018 - 2019
Blinded Intra-Class Correlations of WECS Scores; Clinical intra-class correlations of WECS Scores. The Welch Emotional Connection Scale (WECS) is an investigational developmental screening tool, developed to rate the quality of the emotional connection that formed between mother and child. The scale 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 WECS is scored on intervals of 0.25, with a minimum of 1 (little or no connection) and maximum of 3 (high connection). Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes."
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 15 Feb 2023.
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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 Welch, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Premature Birth, 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 1 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 15 Feb 2023. 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?
Intra-Class Correlations of Welch Emotional Connection Screen (WECS) Scores (time frame: 2018 - 2019). 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 15 Feb 2023.