Early Behavioral Intervention for Preterm Infants (EBI)

Columbia University

Status: Terminated

Conditions: Premature Birth

Treatments: Behavioral: Play and Nutrition Intervention; Behavioral: Family Nurture Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02379130

AAAO2957

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 30 to 40 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

Family Nurture Intervention Group

Experimental group

Description:

Children in the FNI group will continue to attend any intervention programs that they are already enrolled in. In addition, they will be asked to attend 1 clinic visit per week for 6 weeks over the course of 12 weeks. During each visit, the mother-child will meet with trained Nurture Specialists. The Nurture Specialists will facilitate and encourage the mother and child to engage in nurturing and calming activities, including sustained touch, vocal soothing, and an odor cloth exchange. FNI families will be asked to participate in a 6 month post-enrollment follow-up visit and a 12 month post-enrollment follow-up visit.

Treatment:

Behavioral: Family Nurture Intervention

Play and Nutrition Intervention Group

Active Comparator group

Description:

Children in the PNI group will continue to attend any intervention programs that they are already enrolled in. They will be asked to attend 1 clinic visit per week for 6 weeks over the course of 12 weeks to meet with clinical personnel who will collect measures regarding the child's behavior and development. At each visit, study staff will meet with mothers to facilitate a lesson plan on appropriate play and nutrition. NPI families will be asked to participate in a 6 month post-enrollment follow-up visit and a 12 month post-enrollment follow-up visit.

Treatment:

Behavioral: Play and Nutrition Intervention