NCT04048720

Norwalk Feasibility Study

Norwalk Drop-In Family Nurture Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 24 Months – 78 Months
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Family Nurture Intervention	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 be offered eight group FNI sessions.

Timeline

• Start date: 2019-07-05
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-08-07
• Last updated: 2020-11-09

Locations

1 site across 1 country: United States