Children's Learning Centers Group FNI

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03908268
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	N/A
Start date	January 29, 2019
Completion date	June 11, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04725721` - Testing FIRST in Youth Outpatient Psychotherapy	N/A
Completed	`NCT03687879` - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Completed	`NCT03599648` - The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay	N/A
Active, not recruiting	`NCT03641664` - FCT Study: Reducing the Need for Out-of-Home Placements	N/A
Recruiting	`NCT06228950` - Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment	N/A
Recruiting	`NCT05581914` - Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems	N/A
Not yet recruiting	`NCT03260296` - Smartphones Addiction in Assiut University Students	N/A
Completed	`NCT02970565` - Family Nurture Intervention, A Group Model in Connecticut	N/A
Recruiting	`NCT05280613` - The Family Check-Up in Autism Services	N/A
Recruiting	`NCT05603000` - Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties	N/A
Completed	`NCT04547192` - Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form	N/A
Completed	`NCT05008354` - Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam	Phase 4
Completed	`NCT03298724` - Teachers and Parents as Partners During Middle School	N/A
Completed	`NCT03709472` - Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth	N/A
Enrolling by invitation	`NCT04001140` - Enhancement of Emotion Regulation Skills in Adolescents	N/A
Active, not recruiting	`NCT05856435` - Tailoring CPP for the Foster Care Setting	N/A
Completed	`NCT03694314` - Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)	N/A
Recruiting	`NCT04298437` - Addressing Depression and Positive Parenting Techniques (ADAPT)	N/A
Recruiting	`NCT05667675` - Targeting Child Mental Health and Household Poverty	N/A
Recruiting	`NCT05273320` - Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.