Relation, Mother-ChildNCT03908268
Children's Learning Centers Group FNI
A study testing Family Nurture Intervention (FNI) and Standard Children's Learning Center (CLC) Program in people with Relation, Mother-Child and Family Conflict, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). Read more about this study
- Who is it for?
- Ages 24 to 57 monthsHealthy volunteers can take part
- Conditions the study is for
- Relation, Mother-Child, Family Conflict, Emotional Disturbances
- What is being tested?
- Family Nurture Intervention (FNI) and Standard Children's Learning Center (CLC) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 11 Jun 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 24 to 57 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother is able to consent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Child is between the ages of 2 to 4 years and 9 months at date of enrollment
- Child resides with mother
Who cannot join
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
- Mother is more than four months pregnant
Show all 9Show fewer
- Mother and/or infant has a medical condition or contagion that precludes intervention components
- Mother is unable to commit to study schedule
- Mother is currently involved with the Department of Children and Families (DCF)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Learning Centers of Fairfield County
Cos Cob, Connecticut, 06807
About this study
Official title: Group Family Nurture Intervention: Short and Long Term Effects on Preschool Aged Children and Their Mothers at Children's Learning Centers
The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.
Read the detailed description
This study tests a group model of Family Nurture Intervention (FNI), a novel family-based intervention that facilitates mother-child emotional connectedness and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, according to the investigators' Calming Cycle Theory, the ability of the mother-child dyad to promote optimal development is dependent on the dyad's ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both. This study aims to investigate the short and long term effects of FNI in a multiple family group setting for preschool aged children to prevent and/or treat developmental/behavioral problems.
Previously, FNI implemented in the Neonatal Intensive Care Unit (NICU) for premature infants and their mothers at Columbia University Medical Center demonstrated that FNI positively alters neurodevelopment of premature infants. Infants who received FNI in the NICU demonstrated increased brain activity in the prefrontal cortex at term age, improved cognitive and language development at 18 months as measured by the Bayley Scales of Infant Development, improved behavior on the Child Behavior Checklist (CBCL) and reduced risk for autism as indicated by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months. The pilot study of FNI with preschool aged children and their mothers shows a 40% reduction in behavioral problems on the CBCL. Accordingly, the investigators hypothesize that the Family Nurture Intervention will alter physiological regulatory capacities and will result in improved indices of mother-child emotional connection and other outcomes in the preschool population similar to the results in the preterm population.
- Conditions
- Relation, Mother-Child, Family Conflict, Emotional Disturbances, Behavior Problem, Development Delay
- Being tested
- Family Nurture Intervention (FNI), Standard Children's Learning Center (CLC) Program
- Keywords
- Co-regulation, Emotional Connection, Family Nurture Intervention, Preschool Intervention, Martha G. Welch MD, Multiple Family Group Intervention, Randomized Controlled Trial
- Medical subject headings
- Affective Symptoms, Mental Disorders, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Nurture Intervention (FNI)Behavioural
Also called FNI
The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will attend eight group FNI sessions within sixteen weeks.
Standard Children's Learning Center (CLC) ProgramBehavioural
Also called CLC
Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.
| Study group | Role | What they receive |
|---|---|---|
| CLC Program | Active comparator | Half of the mother-child dyads who are enrolled in the study will be randomly assigned to the Standard Children's Learning Center Program group. Receives: Behavioral: Standard Children's Learning Center (CLC) Program |
| FNI plus CLC Program | Experimental | Half of the mother-child dyads who are enrolled in the study will be randomly assigned to the Family Nurture Intervention plus Standard CLC Program group. Receives: Behavioral: Family Nurture Intervention (FNI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Videotaped Interrupted Welch Lap Test
Mother-child interactions will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS).
The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.
Measured: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary outcomes (4)
Respiration
Using a Biopac respiration belt, the respiration rate of mother and child will be measured during each assessment and used to compute vagal tone.
Measured: Baseline, after 8 sessions/weeks and at 6-months post-accrual
ECG
Using a Biopac heart rate monitor and electrodes, the heart rate of mother and child during assessment will be measured. The change in R-R wave interval of mother and child throughout the assessment will be computed and used to compute vagal tone.
Measured: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Change in Maternal Symptoms of Anxiety and Depression
Measured via self-report on the Center for Epidemiologic Studies Depression Scale (CES-D), which measures symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual - Fifth Edition (DSM-V). Mothers are asked to respond to questions such as "I felt hopeful about the future." Responses range from "rarely or none of the time" to "most or all of the time." "Rarely..." earns a 0 while "most..." earns a 3, with the two responses in the middle earning a 1 and a 2. Each item in the CES-D is weighted equally. Scores are summed to equal a total score. A lower total score indicates the individual is minimally depressed (better outcome), whereas a higher total score indicates the individual is more severely depressed (worse outcome).
Measured: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Change in Maternal Symptoms of Anxiety and Depression
Measured via self-report on the Resilience/Stress (R/S) Questionnaire, a metric of the stress and resilience the mother experienced and developed during her childhood. The R/S Questionnaire is presented in a Likert scale format, asking the mother to respond to statements such as "I believe that my mother loved me when I was little." Potential answers range from "definitely true" to "definitely not true," where "definitely true" earns 1 point while "definitely not true" earns 5. Total scores are calculated by summing the points attributed to each response. A lower total score indicates that the mother had a healthy support system and experienced situations benefiting her psychological health. In contrast, multiple statements answered "definitely not true" or "probably not true," indicates a worse outcome, a lack of social support or psychological well-being during the mother's childhood.
Measured: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start29 Jan 2019
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relation, Mother-ChildStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Learning Centers of Fairfield County
- Responsible party
- Principal investigator, Martha G Welch, Columbia University
- Investigators
- Martha Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908268
- Sponsor's protocol ID
- AAAS1630
- Status last verified
- Feb 2023
- First submitted
- 17 Dec 2018
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Welch MG, Myers MM, Grieve PG, Isler JR, Fifer WP, Sahni R, Hofer MA, Austin J, Ludwig RJ, Stark RI; FNI Trial Group. Electroencephalographic activity of preterm infants is increased by Family Nurture Intervention: a randomized controlled trial in the NICU. Clin Neurophysiol. 2014 Apr;125(4):675-684. doi: 10.1016/j.clinph.2013.08.021. Epub 2013 Oct 17.
PubMed 24140072Welch 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 25763525Myers MM, Grieve PG, Stark RI, Isler JR, Hofer MA, Yang J, Ludwig RJ, Welch MG. Family Nurture Intervention in preterm infants alters frontal cortical functional connectivity assessed by EEG coherence. Acta Paediatr. 2015 Jul;104(7):670-7. doi: 10.1111/apa.13007. Epub 2015 Apr 13.
PubMed 25772627Markowitz ES, Maier MC, Ludwig RJ, Austin J, Maybach AM, Jaffe ME, Welch MG. Qualitative insights from a randomized clinical trial of a mother-child emotional preparation program for preschool-aged children. BMC Psychol. 2023 Sep 1;11(1):257. doi: 10.1186/s40359-023-01288-y.
PubMed 37653536
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
- Group Family Nurture Intervention: Short and Long Term Effects on Preschool Aged Children and Their Mothers at Children's Learning Centers
- ClinicalTrials.gov ID
- NCT03908268
- Acronym / sponsor ID
- AAAS1630
- Conditions
- Relation, Mother-Child, Family Conflict, Emotional Disturbances, Behavior Problem, Development Delay
- Keywords
- Co-regulation, Emotional Connection, Family Nurture Intervention, Preschool Intervention, Martha G. Welch MD, Multiple Family Group Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Children's Learning Centers of Fairfield County
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 9 Apr 2019 (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 compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.
Detailed description
This study tests a group model of Family Nurture Intervention (FNI), a novel family-based intervention that facilitates mother-child emotional connectedness and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, according to the investigators' Calming Cycle Theory, the ability of the mother-child dyad to promote optimal development is dependent on the dyad's ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both. This study aims to investigate the short and long term effects of FNI in a multiple family group setting for preschool aged children to prevent and/or treat developmental/behavioral problems.
Previously, FNI implemented in the Neonatal Intensive Care Unit (NICU) for premature infants and their mothers at Columbia University Medical Center demonstrated that FNI positively alters neurodevelopment of premature infants. Infants who received FNI in the NICU demonstrated increased brain activity in the prefrontal cortex at term age, improved cognitive and language development at 18 months as measured by the Bayley Scales of Infant Development, improved behavior on the Child Behavior Checklist (CBCL) and reduced risk for autism as indicated by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months. The pilot study of FNI with preschool aged children and their mothers shows a 40% reduction in behavioral problems on the CBCL. Accordingly, the investigators hypothesize that the Family Nurture Intervention will alter physiological regulatory capacities and will result in improved indices of mother-child emotional connection and other outcomes in the preschool population similar to the results in the preterm population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLC Program | Active comparator | Behavioral: Standard Children's Learning Center (CLC) ProgramHalf of the mother-child dyads who are enrolled in the study will be randomly assigned to the Standard Children's Learning Center Program group. |
| FNI plus CLC Program | Experimental | Behavioral: Family Nurture Intervention (FNI)Half of the mother-child dyads who are enrolled in the study will be randomly assigned to the Family Nurture Intervention plus Standard CLC Program group. |
Who may qualify
- Ages
- 24 to 57 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mother is able to consent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Child is between the ages of 2 to 4 years and 9 months at date of enrollment
- Child resides with mother
Key exclusion criteria (9 listed)
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
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)Also: FNIThe mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will attend eight group FNI sessions within sixteen weeks. | Behavioural | FNI plus CLC Program |
| Standard Children's Learning Center (CLC) ProgramAlso: CLCTypical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions. | Behavioural | CLC Program |
Primary outcome
Change in Videotaped Interrupted Welch Lap Test
Time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Mother-child interactions will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS). The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.
4 secondary outcomes
Respiration
Time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
ECG
Time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Change in Maternal Symptoms of Anxiety and Depression
Time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Change in Maternal Symptoms of Anxiety and Depression
Time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
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 24140072Welch MG, Myers MM, Grieve PG, Isler JR, Fifer WP, Sahni R, Hofer MA, Austin J, Ludwig RJ, Stark RI; FNI Trial Group. Electroencephalographic activity of preterm infants is increased by Family Nurture Intervention: a randomized controlled trial in the NICU. Clin Neurophysiol. 2014 Apr;125(4):675-684. doi: 10.1016/j.clinph.2013.08.021. Epub 2013 Oct 17.
- 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 25772627Myers MM, Grieve PG, Stark RI, Isler JR, Hofer MA, Yang J, Ludwig RJ, Welch MG. Family Nurture Intervention in preterm infants alters frontal cortical functional connectivity assessed by EEG coherence. Acta Paediatr. 2015 Jul;104(7):670-7. doi: 10.1111/apa.13007. Epub 2015 Apr 13.
- Derived from this study: PubMed 37653536Markowitz ES, Maier MC, Ludwig RJ, Austin J, Maybach AM, Jaffe ME, Welch MG. Qualitative insights from a randomized clinical trial of a mother-child emotional preparation program for preschool-aged children. BMC Psychol. 2023 Sep 1;11(1):257. doi: 10.1186/s40359-023-01288-y.
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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?
A study testing Family Nurture Intervention (FNI) and Standard Children's Learning Center (CLC) Program in people with Relation, Mother-Child and Family Conflict, 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 4 inclusion and 9 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?
Change in Videotaped Interrupted Welch Lap Test (time frame: Baseline, after 8 sessions/weeks and at 6-months post-accrual). 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 NCT03908268, which also lists 4 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.