Clinical trial NCT04048720: Norwalk Feasibility Study
Official title: Norwalk Drop-In Family Nurture Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Development Delay
Emotional Disturbances
Family Conflict
Relation, Mother-Child
Keywords: Family Nurture Intervention
Martha G. Welch MD
Feasibility Study
Preschool intervention
Co-regulation
Emotional Connection
Multiple Family Group Intervention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Norwalk Housing Authority (NHA)
First posted: 2019-08-07
Enrollment: 38
Sex: ALL
Minimum age (years): 24
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Feasibility of the Program will be measured through costs, staffing, space availability, and uptake. Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize that the Family Nurture Intervention will show feasibility through attendance and positive response to the Drop-In format. The investigators also expect the Family Nurture Intervention to improve mother's perceived well-being and mother-child emotional connection.

Detailed description: Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child.

This study aims to investigate the feasibility and short term effects of participation in the Family Nurture Intervention for preschool aged children with developmental and behavior problems. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. Intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.

Eligibility criteria: Inclusion Criteria:

* Mother is fluent in English or Spanish
* Mother is 18 years of age or older at the time of consent
* Mother-child pair does not demonstrate emotional connection as measured by the WECS
* Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
* 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

Primary outcomes:
measure: Mother-child session interest
timeFrame: 8 weeks
measure: Change in videotaped Welch Lap Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Norwalk Housing Authority
state: Connecticut
Study officials:
affiliation: Columbia University
name: Martha Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: