Children's Learning Centers Group FNI

NCT03908268 | Completed DMC

• 1 other identifier: AAAS1630
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Respiration

  Baseline, after 8 sessions/weeks and at 6-months post-accrual

• ECG

  Baseline, after 8 sessions/weeks and at 6-months post-accrual

• Change in Maternal Symptoms of Anxiety and Depression

  Baseline, after 8 sessions/weeks and at 6-months post-accrual

• Change in Maternal Symptoms of Anxiety and Depression

  Baseline, after 8 sessions/weeks and at 6-months post-accrual

Study Arms (2)

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.

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.

Behavioral: Family Nurture Intervention (FNI)

Interventions

Family Nurture Intervention (FNI) BEHAVIORAL

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.

Also known as: FNI

FNI plus CLC Program

Standard Children's Learning Center (CLC) Program BEHAVIORAL

Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.

Also known as: CLC

CLC Program

Eligibility Criteria

• Age: 24 Months - 57 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• Children's Learning Centers of Fairfield County: collaborator

Study Sites (1)

Children's Learning Centers of Fairfield County

Cos Cob, Connecticut, 06807, United States

Location

Related Publications (4)

• 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.

  PMID: 24140072 BACKGROUND

• 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.

  PMID: 25763525 BACKGROUND

• 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.

  PMID: 25772627 BACKGROUND

• Markowitz 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.

  PMID: 37653536 DERIVED

MeSH Terms

Conditions

Affective Symptoms; Mental Disorders; Learning Disabilities

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Study Officials

• Martha Welch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: April 9, 2019
• Study Start: January 29, 2019
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)