Norwalk Feasibility Study

NCT ID: NCT04048720

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2019-10-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Family Nurture Intervention (FNI)

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.

Group Type: EXPERIMENTAL

Family Nurture Intervention

Intervention Type: 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 be offered eight group FNI sessions.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FNI

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 78 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwalk Housing Authority (NHA)

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha Welch, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Norwalk Housing Authority

Norwalk, Connecticut, United States

Countries

United States

Other Identifiers

AAAS0112

Identifier Type: -

Identifier Source: org_study_id