Children's Learning Centers Group FNI

Behavior Problem Clinical Trial

Official title:

Group Family Nurture Intervention: Short and Long Term Effects on Preschool Aged Children and Their Mothers at Children's Learning Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908268
• Other study ID #: AAAS1630
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: June 11, 2020

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 57 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Affective Symptoms
• Behavior Problem
• Development Delay
• Emotional Disturbances
• Family Conflict
• Problem Behavior
• Relation, Mother-Child

Intervention

Behavioral:
• Family Nurture Intervention (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) Program
Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.

Locations

Country	Name	City	State
United States	Children's Learning Centers of Fairfield County	Cos Cob	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Children's Learning Centers of Fairfield County

Country where clinical trial is conducted

United States, 

References & Publications (3)

Myers 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary	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.	Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary	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.	Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary	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).	Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary	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.	Baseline, after 8 sessions/weeks and at 6-months post-accrual