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Family Nurture Intervention, A Group Model in Connecticut

Primary Purpose

Behavior Problem, Development Delay, Emotional Disturbance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Nurture Intervention
Nutrition and Play 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, Randomized Control Trial, Pre-school Intervention, Preschool Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation

Eligibility Criteria

24 Months - 54 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child is a singleton
  • Mother can speak in English or Spanish
  • Child is between the ages of 2 to 4 ½ years at date of enrollment
  • Mother is 18 years of age or older at the time of consent
  • Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better)
  • Child must reside 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
  • 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 has any current involvement with Child Protective Services (Department of Children and Families)
  • Mother is pregnant
  • Mother and/or infant has a medical condition or contagion that precludes intervention components

Sites / Locations

  • Norwalk Housing Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nutrition and Play Intervention

Family Nurture Intervention

Arm Description

Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.

Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.

Outcomes

Primary Outcome Measures

Change in Childhood Behavior Checklist (CBCL) Score
The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.

Secondary Outcome Measures

Co-regulation of Vagal Tone
Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.
Change in Maternal Anxiety and Depressive Symptoms
Mothers will complete various questionnaires measuring their mood and state.
Changes in Welch Emotional Connection Scale
This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.

Full Information

First Posted
November 18, 2016
Last Updated
February 13, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT02970565
Brief Title
Family Nurture Intervention, A Group Model in Connecticut
Official Title
Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
Detailed Description
There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Development Delay, Emotional Disturbance, Family Conflict
Keywords
Family Nurture Intervention, Martha G. Welch MD, Randomized Control Trial, Pre-school Intervention, Preschool Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition and Play Intervention
Arm Type
Experimental
Arm Description
Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Arm Title
Family Nurture Intervention
Arm Type
Experimental
Arm Description
Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
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 they customarily do. 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, comfort touch, soothing words, and eye contact.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and Play Intervention
Other Intervention Name(s)
NPI
Intervention Description
Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
Primary Outcome Measure Information:
Title
Change in Childhood Behavior Checklist (CBCL) Score
Description
The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Co-regulation of Vagal Tone
Description
Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.
Time Frame
Up to 12 months
Title
Change in Maternal Anxiety and Depressive Symptoms
Description
Mothers will complete various questionnaires measuring their mood and state.
Time Frame
Up to 12 months
Title
Changes in Welch Emotional Connection Scale
Description
This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child is a singleton Mother can speak in English or Spanish Child is between the ages of 2 to 4 ½ years at date of enrollment Mother is 18 years of age or older at the time of consent Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more on the total score excluding the pro-social questions; OR 4 or less on the pro-social questions, which are reverse scored i.e. higher is better) Child must reside 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 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 has any current involvement with Child Protective Services (Department of Children and Families) Mother is pregnant Mother and/or infant has a medical condition or contagion that precludes intervention components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha G Welch, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwalk Housing Authority
City
Cos Cob
State/Province
Connecticut
ZIP/Postal Code
06807
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Family Nurture Intervention, A Group Model in Connecticut

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