Clinical trial NCT02970565: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 106
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 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

Primary outcomes:
measure: Change in Childhood Behavior Checklist (CBCL) Score
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Co-regulation of Vagal Tone
timeFrame: Up to 12 months
measure: Change in Maternal Anxiety and Depressive Symptoms
timeFrame: Up to 12 months
measure: Changes in Welch Emotional Connection Scale
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Cos Cob
country: United States
facility: Norwalk Housing Authority
state: Connecticut
Study officials:
affiliation: Columbia University
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: