Clinical trial NCT02379130: Early Behavioral Intervention for Preterm Infants
Official title: FNI Between Mothers and Preschool Age Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Keywords: Premature
Family Nurture Intervention
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4.5 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems and behavioral problems.

Detailed description: Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems (Hofer, 1987). For the developing infant, one of the most critical sources of regulatory input is through contact with the mother and her nurturing behavior. The infant's responses to the mother provide feedback that shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains (Als, 1999). A necessary but detrimental separation between mother and infant is created at a critical period when mother-infant co-regulation should be developing. Regardless of NICU or well-baby nursery care, the physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions are key factors underlying the risks of early and late preterm infants for a broad range of early and midlife disorders (DeBoer, et al., 1984 if this does not include late preterm, find another reference). This study compares common early interventions such as occupational, physical, and speech therapy with a Family Nurture Intervention (FNI), instituted at age 3 to 4 for preschool aged children with developmental delays. This is a developmental time point at which delays including deficits in emotion regulation, language, cognition, and attention are identifiable. The investigators hypothesize that the Family Nurture Intervention will alter a wide range of physiological regulatory capacities and will result in improved indices of mother psychological and child neurobehavioral outcomes.

Eligibility criteria: Inclusion Criteria:

* Infant is a singleton (matched between groups)
* Mother is 18 years of age or older
* Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent)
* Child demonstrates developmental deficit (language, cognition, motor, emotion)

Exclusion Criteria:

* The child has severe congenital anomalies including chromosomal anomalies
* The child has severe motor or physical disability
* Mother currently presents with psychosis or is currently taking antipsychotic medication
* Status of enrolled subject changes and subject no longer falls in inclusion criteria
* Mother and/or infant has a medical condition that precludes intervention components
* Mother and/or infant has a contagion that endangers other participants in the study

Primary outcomes:
measure: Child Behavior Checklist (CBCL) Scale
timeFrame: Baseline, 5 weeks, 6 months, 12 months
Secondary outcomes:
measure: Salivary Cortisol Level
timeFrame: Up to 3 years
measure: Oxytocin (OT) Level
timeFrame: Up to 3 years
measure: Variance in Vagal Tone (High Frequency Heart Period Variability)
timeFrame: Up to 3 years
measure: Strengths and Difficulties Questionnaire (SDQ) Score
timeFrame: Up to 3 years
measure: Sleep Habits Questionnaire (SHQ) Score
timeFrame: Up to 3 years
measure: State-Trait Anxiety Inventory (STAI) Scale
timeFrame: Up to 3 years
measure: Parenting Stress Index (PSI) Scale
timeFrame: Up to 3 years
measure: Center for Epidemiologic Studies Depression (CES-D) Score
timeFrame: Up to 3 years
measure: Maternal Self Efficacy Scale
timeFrame: Up to 3 years
measure: Norbeck Social Support Questionnaire (NSSQ) Score
timeFrame: Up to 3 years
measure: Mom's Support Circle Scale
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: New York City
country: United States
facility: Columbia University Medical Center - Nuture Science Center
state: New York
Study officials:
affiliation: Lab Manager, Nurture Science Progam, Columbia University Medical Center
name: Robert J Ludwig, BA
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
References: