Family Nurture Intervention, A Group Model in Connecticut
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFebruary 15, 2023
February 1, 2023
2.6 years
November 18, 2016
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 6 months
Secondary Outcomes (3)
Co-regulation of Vagal Tone
Up to 12 months
Change in Maternal Anxiety and Depressive Symptoms
Up to 12 months
Changes in Welch Emotional Connection Scale
Up to 12 months
Study Arms (2)
Nutrition and Play Intervention
EXPERIMENTALMother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Family Nurture Intervention
EXPERIMENTALMother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Interventions
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.
Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norwalk Housing Authority
Cos Cob, Connecticut, 06807, United States
Related Publications (1)
Welch MG, Ludwig RJ, Hane AA, Austin J, Markowitz ES, Jaffe ME, Myers MM. Preschool-based mother-child emotional preparation program improves emotional connection, behavior regulation in the home and classroom: a randomized controlled trial. Front Child Adolesc Psychiatry. 2023 Oct 20;2:1232515. doi: 10.3389/frcha.2023.1232515. eCollection 2023.
PMID: 39816857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha G Welch, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 22, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share