Child DevelopmentNCT03680001
Students Education Training in Emotional Connection
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 assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Child Development, Premature Birth
- What is being tested?
- Training in Rating Emotional Connection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 30 Nov 2018
- 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 20 to 40 years
- All sexes
- Adult
Study population: Graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work
Who may be able to join
- graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work
Who cannot join
- refusal to participate
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 assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy.
The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.
Read the detailed description
The purpose of this study is to develop and test educational modules designed to instruct students how to assess the quality and strength of mother-child relationships. The approach will use constructs of Emotional Connection that were used in development of an investigational observation-based screening instrument, the Welch Emotional Connection Screen (WECS). The WECS allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed face-to face interaction, and shows preliminary predictive properties when performed in the first year of life.
Administration of the WECS involves watching recorded interactions of a child sitting face-to-face on the mother's lap, and scoring the interaction on sliding scales per 4 domains. During the WECS development, the Nurture Science Program of Columbia University Irving Medical Center created and coded hours of parent-child interaction videos. These videos will be used to assess and train the students (subjects) on rating mother/child dyads around emotional connection. Subjects will rate the quality of mother-child relationships in video training sets after completing one of two educational modules: A) a lecture-style webinar describing evidence base and instructions on how to score the WECS B) a guide written in Clear Explicit Translatable Language (CETL). Training set results of students in these groups will be compared to results of students who received no prior training. Training set results will be analyzed for the reliability statistic between student scores and key scores established by writer of the scale and PI. Subjects will then spend 3 months without further training in emotional connection or practice coding WECS. Subjects will then rate the quality of mother-child relationships for videos of dyads they hadn't previously seen. The main outcome of this study is the comparison of reliability statistics and maintenance between students who completed different educational modules.
- Conditions
- Child Development, Premature Birth
- Being tested
- Training in Rating Emotional Connection
- Keywords
- emotional connection, Martha G. Welch, nursing education
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in Rating Emotional ConnectionBehavioural
Didactic education (video-supported educational module) on emotional connectivity will be offered to the subjects. Subjects will conference with PI to review ratings on modules.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Class Correlations of Students' Welch Emotional Connection Screen (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). High connection is considered optimal for child development, and low connection is considered a risk in child development.
Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes." Observing these scores could help determine if the educational module is successful in training students to assess the emotional connection.
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 start14 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 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 G Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680001
- Sponsor's protocol ID
- AAAS0330
- 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
Publications
Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, Garland M, Glickstein SB, Brunelli SA, Ludwig RJ, Myers MM. Family Nurture Intervention in the Neonatal Intensive Care Unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. J Child Psychol Psychiatry. 2015 Nov;56(11):1202-11. doi: 10.1111/jcpp.12405. Epub 2015 Mar 11.
PubMed 25763525Hane AA, LaCoursiere JN, Mitsuyama M, Wieman S, Ludwig RJ, Kwon KY, V Browne J, Austin J, M Myers M, Welch MG. The Welch Emotional Connection Screen: validation of a brief mother-infant relational health screen. Acta Paediatr. 2019 Apr;108(4):615-625. doi: 10.1111/apa.14483. Epub 2018 Aug 13.
PubMed 29959878
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
- Students Education Training in Emotional Connection
- ClinicalTrials.gov ID
- NCT03680001
- Acronym / sponsor ID
- AAAS0330
- Conditions
- Child Development, Premature Birth
- Keywords
- emotional connection, Martha G. Welch, nursing education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (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 assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy.
The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.
Detailed description
The purpose of this study is to develop and test educational modules designed to instruct students how to assess the quality and strength of mother-child relationships. The approach will use constructs of Emotional Connection that were used in development of an investigational observation-based screening instrument, the Welch Emotional Connection Screen (WECS). The WECS allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed face-to face interaction, and shows preliminary predictive properties when performed in the first year of life.
Administration of the WECS involves watching recorded interactions of a child sitting face-to-face on the mother's lap, and scoring the interaction on sliding scales per 4 domains. During the WECS development, the Nurture Science Program of Columbia University Irving Medical Center created and coded hours of parent-child interaction videos. These videos will be used to assess and train the students (subjects) on rating mother/child dyads around emotional connection. Subjects will rate the quality of mother-child relationships in video training sets after completing one of two educational modules: A) a lecture-style webinar describing evidence base and instructions on how to score the WECS B) a guide written in Clear Explicit Translatable Language (CETL). Training set results of students in these groups will be compared to results of students who received no prior training. Training set results will be analyzed for the reliability statistic between student scores and key scores established by writer of the scale and PI. Subjects will then spend 3 months without further training in emotional connection or practice coding WECS. Subjects will then rate the quality of mother-child relationships for videos of dyads they hadn't previously seen. The main outcome of this study is the comparison of reliability statistics and maintenance between students who completed different educational modules.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work
Key inclusion criteria (1 listed)
- graduate students from the Columbia University Irving Medical Center campus and from the Columbia School of Social Work
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| Training in Rating Emotional ConnectionDidactic education (video-supported educational module) on emotional connectivity will be offered to the subjects. Subjects will conference with PI to review ratings on modules. | Behavioural | – |
Primary outcome
Intra-Class Correlations of Students' Welch Emotional Connection Screen (WECS) Scores
Time frame: 2018 - 2019
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). High connection is considered optimal for child development, and low connection is considered a risk in child development. Separately from these scores, the final portion of the screen determines, "Is the dyad emotionally connected?" and is scored with "No" or "Yes." Observing these scores could help determine if the educational module is successful in training students to assess the emotional connection.
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.
- Background: PubMed 25763525Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, Garland M, Glickstein SB, Brunelli SA, Ludwig RJ, Myers MM. Family Nurture Intervention in the Neonatal Intensive Care Unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. J Child Psychol Psychiatry. 2015 Nov;56(11):1202-11. doi: 10.1111/jcpp.12405. Epub 2015 Mar 11.
- Background: PubMed 29959878Hane AA, LaCoursiere JN, Mitsuyama M, Wieman S, Ludwig RJ, Kwon KY, V Browne J, Austin J, M Myers M, Welch MG. The Welch Emotional Connection Screen: validation of a brief mother-infant relational health screen. Acta Paediatr. 2019 Apr;108(4):615-625. doi: 10.1111/apa.14483. Epub 2018 Aug 13.
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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
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 Students' 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?
On the ClinicalTrials.gov record for NCT03680001, which also lists 2 linked publications.
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.