Child DevelopmentNCT04233489
Clinical Interventions to Mitigate Neurodevelopmental Risk
A study testing Family Nurture Intervention (FNI) in people with Child Development and Mother-Infant Interaction, run by Columbia University at 1 site in United States.
Trial summary
Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. Read more about this study
- Who is it for?
- Ages 12 hours to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Child Development, Mother-Infant Interaction, Diabetes Mellitus, Gestational
- What is being tested?
- Family Nurture Intervention (FNI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 13 Mar 2020
- 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 12 hours to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically healthy mothers with and without diabetes (type 1, type 2, or gestational) and their infants
- Infants with gestational age between 37 0/7 and 40 6/7
- APGAR score above 7 five minutes after birth
- Infants between 12-72 hours of life at time of the study
- Mothers between 18-50 years old
Who cannot join
- Infants with gestational age below 37 0/7 or above 40 6/7
- Infant requiring resuscitation at birth
- Infant admitted to NICU
- Prenatal exposures to psychiatric medications, alcohol, recreational drug use, or smoking
- HIV-positive mother
- Mother with psychiatric diagnosis
- Infant with genetic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital of New York
New York, New York, 10032
About this study
Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.
Read the detailed description
The long-term objective of this work is to improve cognitive, emotional, and social developmental trajectories in at-risk children. Specially, this pilot study will assess the feasibility of Family Nurture Intervention (FNI) in the neonatal period during the infants' stay in the Well Baby Nursery (WBN) in improving developmental trajectories.
FNI is a family-based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a trained provider. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants.
In this study, the goal is to extend of the findings of FNI to another population of at risk infants - infants born to mothers suffering from gestational diabetes mellitus (GDM). These infants are generally healthy but at higher risk than controls in developing mild cognitive and motor impairments.
In this pilot phase, infants exposed to GDM and case-matched control infants will both receive FNI: (GDM+FNI and Control+FNI). These two groups will be compared to an already existing protocol and pool of participants who did not receive FNI: (GDM+no FNI and Control+no FNI). This allows the study to evaluate both GDM versus control infants as well as the presence of FNI versus no FNI.
The goal is to pilot the potential role of a short, one-time session of FNI in promoting neurodevelopment among an at-risk wellbaby nursery population. This will be achieved by comparing developmental milestones, such as cognitive and motor development, memory, attention, and emotion regulation at 6 and 15 months, between participants who received the FNI and those who did not. Another goal is to elucidate the role FNI has on autonomic co-regulation and mother-infant synchrony through physiological recordings during the FNI session in the WBN.
- Being tested
- Family Nurture Intervention (FNI)
- Keywords
- mother-infant dyad, family nurture intervention, emotional connection, synchrony, mother-infant interaction, child development, Diabetes Mellitus, Gestational
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Nurture Intervention (FNI)Behavioural
FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician.
The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU).
| Study group | Role | What they receive |
|---|---|---|
| Family Nurture Intervention (FNI) | Experimental | This arm contains the combined GDM+FNI and control+FNI cohort. Receives: Behavioral: Family Nurture Intervention (FNI) |
| Non-FNI | No intervention | This arm contains the combined GDM+no FNI and control+no FNI cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Welch Emotional Connection Score
The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication and sensitivity/reciprocity. Each domain is scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. The WECS will be measured at baseline for the FNI groups during the intervention, and at 15 months for both FNI and non-FNI groups by a researcher observing the dyadic interaction during a 3 minute period of face-to-face time. Changes in score from baseline to 15 months will be evaluated for FNI groups. Differences in emotional connection will be evaluated in FNI versus non-FNI groups by comparing WECS scores at 15-months.
Measured: Baseline and 15-months of age
Change in heart rhythm synchrony
Heart rhythms will be collected through non-invasive EKG monitoring of mother and infant during FNI in order to test the hypothesis that FNI improves emotional connection through autonomic synchrony. To test this, peaks will be extracted from the EKG traces of mother and infant and cross-correlation functions will be used to assess if physiological synchrony between mother-infant heart beats increases throughout the FNI session. Synchrony at the end of the session will also be used to ascertain if autonomic synchrony can be used as a predictor of WECS score or other outcomes at the follow-up sessions.
Measured: Baseline
Change in Social-Emotional Questionnaire (ASQ-SE) Score
The ASQ-SE is a 22-item parent-completed, culturally sensitive questionnaire. It is a screening tool to identify young children who may have social and emotional development trends that warrant further evaluation. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-SE scores of FNI and non-FNI participants measuring self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. This would be assessed
Measured: 6 months (over the phone) and 15 months (in person)
Change in Ages and Stages questionnaire (ASQ-3) Score
The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
Measured: 6 months (over the phone) and 15 months (in person)
Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score
BITSEA is a short 42-item parent-report screening tool used to identify social-emotional/behavioral problems and delays in competence in 12 to 36 month olds. It takes 10 to 15 minutes to complete. The measure yields two scores: a Problem Total Score and Competence Total Score. It also includes a two separate parental "worry" item for parents to rate their concern about the child's behavior and language on a 5-point scale from 1 being not at all worried to 5 being extremely worried. Change in score will be calculated by comparing BITSEA scores of FNI and non-FNI participants.
Measured: 15 months
Secondary outcomes (5)
Change in Parenting Stress Index (PSI-4)
PSI-4 is a 120 item inventory designed to assess the level of stress in the parent-child relationship. It takes 5 minutes to complete. It focuses on three major domains of stress: child characteristics, parent characteristics, and situation/demographic life stress. Change in score will be calculated by comparing PSI-4 scores of mothers in FNI versus non-FNI groups. The child domain, the parent domain, and life stress domains will be compared. Child domain is separated into six subscales: distractibility, hyperactivity, adaptability, reinforces parent, demandingness, mood, and acceptability. Parent domain is separated into seven subscales: competence, isolation, attachment, health, role restriction, depression, and spouse/parenting partner relationship. Life stress provides information about factors outside the parent-child relationship.
Measured: 6 months (over the phone) and 15 months (in person)
Change in Edinburgh Postnatal Depression Scale (EPDS)
EPDS is a 10 question form to identify patients at risk for postnatal depression and has been proven to be an effective screening tool. Mothers who score above 13 are likely to be suffering from a depressive illness. The maximum score is 30. Those who score 10 or greater have possible depression and careful clinical assessment is suggested. The scale indicates how the mother has felt during the previous week. It takes 2 minutes to complete. Change in score will be calculated by comparing EPDS scores of mothers in FNI versus non-FNI groups.
Measured: 15 months
Change in Bayley-III Scale
Bayley-III scale is a comprehensive tool to identify developmental delays during early childhood. It can be used between 1 and 42 months. It takes 30-45 minutes to complete. Five areas of development are assessed: cognitive, language, motor, social-emotional, and adaptive behavior. The cognitive scales comprises of 91 items to assess sensorimotor development, exploration and manipulation, object relatedness, concept formation, and memory. The language area looks at 49 items to assess receptive and 48 items to assess expressive communication. The motor domain assessed 66 items in fine motor and 71 items in gross motor. Social-emotional contains 35 items. Adaptive behavior contains 241 items. Scores for all skill areas combine to form the General Adaptive Composite (GAC) for an overall measure of development. Change in score will be calculated by comparing Bayley-III scores of FNI and non-FNI participants.
Measured: 15 months
Change in Toddler Sensory Profile-2 score
Toddler Sensory Profile-2 evaluates a child's sensory processing patterns in the context of home, school, and community activities. Using paper and pencil or an online form, caregivers or administration fill out a questionnaire for toddlers ages 7 to 35 months. It takes 10 minutes to complete. Each form includes measurements on sensory system, behavior, sensory pattern, and school factors. Change in score will be calculated by comparing Toddler Sensory Profile-2 scores of FNI and non-FNI participants.
Measured: 15 months
Change in M/CHAT R/F score
Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M/CHAT R/F) is a 2-stage parent-report screening tool to evaluate for Autism Spectrum Disorder (ASD) in toddlers between 16 to 30 months of age. The tool maximizes sensitivity and aims to detect as many cases of ASD as possible, and thus has high false positives. It takes 5 minutes to complete. A total score of 0-2 is low risk, 3-7 is medium, and 8-20 is high. An interview via flowchart format is also administered asking questions until a PASS or FAIL is scored. The interview is considered to screen positive if the child fails any two items on the follow-up.Change in score will be calculated by comparing M/CHAT R/F scores of FNI and non-FNI participants
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start3 Jan 2020
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: The COVID-19 pandemic lead to halted protocols containing human subjects and in person interactions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Responsible party
- Sponsor
- Investigators
- Dani Dumitriu, MD/PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233489
- Sponsor's protocol ID
- 7857
- Status last verified
- Oct 2022
- First submitted
- 15 Jan 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
PubMed 30284883Isler JR, Stark RI, Grieve PG, Welch MG, Myers MM. Integrated information in the EEG of preterm infants increases with family nurture intervention, age, and conscious state. PLoS One. 2018 Oct 24;13(10):e0206237. doi: 10.1371/journal.pone.0206237. eCollection 2018.
PubMed 30356312Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14.
PubMed 22314029Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
PubMed 24063360Welch 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 25763525Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.
PubMed 21767879
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Interventions to Mitigate Neurodevelopmental Risk
- ClinicalTrials.gov ID
- NCT04233489
- Acronym / sponsor ID
- 7857
- Keywords
- mother-infant dyad, family nurture intervention, emotional connection, synchrony, mother-infant interaction, child development, Diabetes Mellitus, Gestational
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID-19 pandemic lead to halted protocols containing human subjects and in person interactions
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 18 Jan 2020 (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.
Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.
Detailed description
The long-term objective of this work is to improve cognitive, emotional, and social developmental trajectories in at-risk children. Specially, this pilot study will assess the feasibility of Family Nurture Intervention (FNI) in the neonatal period during the infants' stay in the Well Baby Nursery (WBN) in improving developmental trajectories.
FNI is a family-based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a trained provider. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants.
In this study, the goal is to extend of the findings of FNI to another population of at risk infants - infants born to mothers suffering from gestational diabetes mellitus (GDM). These infants are generally healthy but at higher risk than controls in developing mild cognitive and motor impairments.
In this pilot phase, infants exposed to GDM and case-matched control infants will both receive FNI: (GDM+FNI and Control+FNI). These two groups will be compared to an already existing protocol and pool of participants who did not receive FNI: (GDM+no FNI and Control+no FNI). This allows the study to evaluate both GDM versus control infants as well as the presence of FNI versus no FNI.
The goal is to pilot the potential role of a short, one-time session of FNI in promoting neurodevelopment among an at-risk wellbaby nursery population. This will be achieved by comparing developmental milestones, such as cognitive and motor development, memory, attention, and emotion regulation at 6 and 15 months, between participants who received the FNI and those who did not. Another goal is to elucidate the role FNI has on autonomic co-regulation and mother-infant synchrony through physiological recordings during the FNI session in the WBN.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Nurture Intervention (FNI) | Experimental | Behavioral: Family Nurture Intervention (FNI)This arm contains the combined GDM+FNI and control+FNI cohort. |
| Non-FNI | No intervention | –This arm contains the combined GDM+no FNI and control+no FNI cohort. |
Who may qualify
- Ages
- 12 hours to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Medically healthy mothers with and without diabetes (type 1, type 2, or gestational) and their infants
- Infants with gestational age between 37 0/7 and 40 6/7
- APGAR score above 7 five minutes after birth
- Infants between 12-72 hours of life at time of the study
- Mothers between 18-50 years old
Key exclusion criteria (7 listed)
- Infants with gestational age below 37 0/7 or above 40 6/7
- Infant requiring resuscitation at birth
- Infant admitted to NICU
- Prenatal exposures to psychiatric medications, alcohol, recreational drug use, or smoking
- HIV-positive mother
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 |
|---|---|---|
| Family Nurture Intervention (FNI)FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician. The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU). | Behavioural | Family Nurture Intervention (FNI) |
Primary outcome
Change in Welch Emotional Connection Score
Time frame: Baseline and 15-months of age
The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication and sensitivity/reciprocity. Each domain is scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. The WECS will be measured at baseline for the FNI groups during the intervention, and at 15 months for both FNI and non-FNI groups by a researcher observing the dyadic interaction during a 3 minute period of face-to-face time. Changes in score from baseline to 15 months will be evaluated for FNI groups. Differences in emotional connection will be evaluated in FNI versus non-FNI groups by comparing WECS scores at 15-months.
Change in heart rhythm synchrony
Time frame: Baseline
Heart rhythms will be collected through non-invasive EKG monitoring of mother and infant during FNI in order to test the hypothesis that FNI improves emotional connection through autonomic synchrony. To test this, peaks will be extracted from the EKG traces of mother and infant and cross-correlation functions will be used to assess if physiological synchrony between mother-infant heart beats increases throughout the FNI session. Synchrony at the end of the session will also be used to ascertain if autonomic synchrony can be used as a predictor of WECS score or other outcomes at the follow-up sessions.
Change in Social-Emotional Questionnaire (ASQ-SE) Score
Time frame: 6 months (over the phone) and 15 months (in person)
The ASQ-SE is a 22-item parent-completed, culturally sensitive questionnaire. It is a screening tool to identify young children who may have social and emotional development trends that warrant further evaluation. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-SE scores of FNI and non-FNI participants measuring self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. This would be assessed
Change in Ages and Stages questionnaire (ASQ-3) Score
Time frame: 6 months (over the phone) and 15 months (in person)
The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score
Time frame: 15 months
BITSEA is a short 42-item parent-report screening tool used to identify social-emotional/behavioral problems and delays in competence in 12 to 36 month olds. It takes 10 to 15 minutes to complete. The measure yields two scores: a Problem Total Score and Competence Total Score. It also includes a two separate parental "worry" item for parents to rate their concern about the child's behavior and language on a 5-point scale from 1 being not at all worried to 5 being extremely worried. Change in score will be calculated by comparing BITSEA scores of FNI and non-FNI participants.
5 secondary outcomes
Change in Parenting Stress Index (PSI-4)
Time frame: 6 months (over the phone) and 15 months (in person)
Change in Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 15 months
Change in Bayley-III Scale
Time frame: 15 months
Change in Toddler Sensory Profile-2 score
Time frame: 15 months
Change in M/CHAT R/F score
Time frame: 15 months
Results and safety
The study was stopped early (reason given: The COVID-19 pandemic lead to halted protocols containing human subjects and in person interactions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 30284883Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
- Background: PubMed 30356312Isler JR, Stark RI, Grieve PG, Welch MG, Myers MM. Integrated information in the EEG of preterm infants increases with family nurture intervention, age, and conscious state. PLoS One. 2018 Oct 24;13(10):e0206237. doi: 10.1371/journal.pone.0206237. eCollection 2018.
- Background: PubMed 22314029Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14.
- Background: PubMed 24063360Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
- 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 21767879Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.
- 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.
Dani Dumitriu, MD/PhD 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?
A study testing Family Nurture Intervention (FNI) in people with Child Development and Mother-Infant Interaction, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Oct 2022. 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 was stopped early (reason given: The COVID-19 pandemic lead to halted protocols containing human subjects and in person interactions). Results are not available in the source record.
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?
Change in Welch Emotional Connection Score (time frame: Baseline and 15-months of age). The study lists 5 primary outcomes in all. 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 NCT04233489, which also lists 6 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 13 Oct 2022.