Clinical trial NCT03442439: Stamford Group Family Nurture Intervention
Official title: Stamford Group Family Nurture Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Developmental Delay
Emotional Disturbances
Family Conflict
Keywords: Family Nurture Intervention
Martha G. Welch MD
Randomized Controlled Trial
Preschool Intervention
Pre-school Intervention
Multiple Family Group Intervention
Emotional Connection
Co-regulation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 24
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Child is a singleton
* Mother can speak, read and write in English or Spanish
* Child is between the ages of 2-4 1/2 years at date of enrollment
* Mother is 18 years of age or older at the time of consent
* Child resides with mother
* Child demonstrates developmental deficit as measured by the Strengths and Difficulties Questionnaire (13 or higher on behavioral questions or 4 or less on prosocial questions)
* Mother and child deemed "emotionally unconnected" using the Welch Emotional Connection Scale (WECS) to score their five minute Welch Lap Test video
* Mother is able to commit to study schedule

Exclusion Criteria:

* The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral palsy
* Child has a motor disability
* Mother sees or hears things that other people do not seem to see or hear
* Mother has trouble distinguishing whether something is real or part of imagination or dreams
* Mother is currently taking antipsychotic medications
* Mother or child have any medical conditions that might prevent them from participating in block play, mother holding child, or child sitting on mother's lap
* Mother has any current drug and/or alcohol abuse
* Mother is more than 4 months pregnant
* Mother is currently involved with Department of Children and Families
* The child has a diagnosis of Autism

Primary outcomes:
measure: Welch Emotional Connection Scale (WECS) Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Childrens Learning Center
state: Connecticut
Study officials:
affiliation: Columbia University
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: