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Norwalk Feasibility Study

NCT04048720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-11-09

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Martha Welch, MD · Columbia University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Months
Max Age
78 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04048720 on ClinicalTrials.gov