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Norwalk Feasibility Study

Primary Purpose

Behavior Problem, Development Delay, Emotional Disturbances

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Nurture Intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Behavior Problem focused on measuring Family Nurture Intervention, Martha G. Welch MD, Feasibility Study, Preschool intervention, Co-regulation, Emotional Connection, Multiple Family Group Intervention

Eligibility Criteria

24 Months - 78 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Norwalk Housing Authority

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Family Nurture Intervention (FNI)

Arm Description

FNI sessions will be held once a week in the afternoon for eight weeks. Participants will take part in FNI group therapy with their child alongside other mother-child pairs. One to two staff members will lead FNI sessions.

Outcomes

Primary Outcome Measures

Mother-child session interest
Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
Change in videotaped Welch Lap Test
Mother-child 5-minute videotaped interactions, recorded weekly after each session, 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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2019
Last Updated
November 6, 2020
Sponsor
Columbia University
Collaborators
Norwalk Housing Authority (NHA)
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1. Study Identification

Unique Protocol Identification Number
NCT04048720
Brief Title
Norwalk Feasibility Study
Official Title
Norwalk Drop-In Family Nurture Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Norwalk Housing Authority (NHA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Nurture Intervention (FNI)
Arm Type
Experimental
Arm Description
FNI sessions will be held once a week in the afternoon for eight weeks. Participants will take part in FNI group therapy with their child alongside other mother-child pairs. One to two staff members will lead FNI sessions.
Intervention Type
Behavioral
Intervention Name(s)
Family Nurture Intervention
Other Intervention Name(s)
FNI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mother-child session interest
Description
Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
Time Frame
8 weeks
Title
Change in videotaped Welch Lap Test
Description
Mother-child 5-minute videotaped interactions, recorded weekly after each session, 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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
78 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Welch, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwalk Housing Authority
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06854
Country
United States

12. IPD Sharing Statement

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Norwalk Feasibility Study

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