Early Behavioral Intervention for Preterm Infants

Premature Birth Clinical Trial

— EBI  

Official title:

FNI Between Mothers and Preschool Age Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02379130
• Other study ID #: AAAO2957
• Status: Terminated
• Phase: N/A
• First received: February 25, 2015
• Last updated: July 26, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 40 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Family Nurture Intervention
The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period the child will sit on the mother's lap. The pair will be asked to talk and play with each other as they customarily do. If the child becomes restless the mother will be coached by the nurture specialist to further engage the child with soothing and calming; the mother will be helped to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact. The mother will also be helped to verbally express her feelings toward her child and to tolerate her child's full range of feeling.
• Play and Nutrition Intervention
The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period, the child and mother will play nutrition-focused games using the Healthy Habits for Life program designed by Michelle Obama.

Locations

Country	Name	City	State
United States	Columbia University Medical Center - Nuture Science Center	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Behavior Checklist (CBCL) Scale	The Child Behavior Checklist (CBCL) is a device by which parents rate a child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items.	Baseline, 5 weeks, 6 months, 12 months	No
Secondary	Salivary Cortisol Level	Cortisol is the hormone produced at the end of the Hypothalamic-Pituitary-Adrenal (HPA) Axis and is used to measure stress levels. Mothers and children will be asked for a saliva sample for cortisol determination throughout the intervention program.	Up to 3 years	No
Secondary	Oxytocin (OT) Level	In this study OT will be measured in urine and saliva of both mother and child to determine the extent to which OT is different in control and intervention subjects. Release of OT under conditions of isolation/stress may help protect mammals against the effects of stress.	Up to 3 years	No
Secondary	Variance in Vagal Tone (High Frequency Heart Period Variability)	Using data obtained during each follow-up visit, we will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate.Heart rate and respiration will be digitized at 2000 samples/sec, and undergo further mean and interval calculations.	Up to 3 years	No
Secondary	Strengths and Difficulties Questionnaire (SDQ) Score	SDQ is a brief parent-report behavioral screening questionnaire for 3-16 year olds. It consists of 25 items that are divided into 5 categories: emotional problems, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.	Up to 3 years	No
Secondary	Sleep Habits Questionnaire (SHQ) Score	SHQ is a 64-item parent report instrument about their child's sleep across the first 5 years of life, beginning at age 6 months.	Up to 3 years	No
Secondary	State-Trait Anxiety Inventory (STAI) Scale	STAI is the definitive instrument for measuring anxiety. It comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety (Spanish version also available). The S-Anxiety Scale (measuring state), has been found to be a sensitive indicator of changes in transitory anxiety. The T-Anxiety scale has proven useful for identifying persons who differ in motivation or drive level. The STAI has been used in studies examining parents of hospitalized children, the transition to a maternal role, and perception of illness severity in infants.	Up to 3 years	No
Secondary	Parenting Stress Index (PSI) Scale	We will be using the short form of 36 items, which only requires 10 mins to complete. This form of the PSI (1983) is from a 101 item questionnaire that includes the following 13 scales: Adaptability, Acceptability, Demandingness, Mood, Distractibility/Hyperactivity, Reinforces Parent, Depression, Attachment, Restriction of Role, Sense of Competence, Social Isolation, Relationship with Spouse, and Parent Health.	Up to 3 years	No
Secondary	Center for Epidemiologic Studies Depression (CES-D) Score	The CES-D is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression. Criteria are based on DSM-IV criteria for depressive disorders. A score of 16+ is traditionally used to select a depressed group.	Up to 3 years	No
Secondary	Maternal Self Efficacy Scale	This is a 10 item measure designed to measure feelings of efficacy in mothers of infants aged 3 to 131 months. Mothers rate their perceived efficacy across a variety of childcare activities along a 4-point scale.	Up to 3 years	No
Secondary	Norbeck Social Support Questionnaire (NSSQ) Score	Respondents are asked to list first names or initials for each significant person in their lives who provides personal support to them. Then they indicate the kind of relationship for each person on this network list. Using a 5-point rating scale they describe the amount of support available from each person on their network list for 8 questions.	Up to 3 years	No
Secondary	Mom's Support Circle Scale	This questionnaire was specifically created for the current study. It assesses who will support and who is supporting the mom with her child. It assess how 'available' and 'helpful' each potential support person (e.g., husband, sibling, grandparent, friend) is on a rating scale from rated from 1 (less) to 5 (more).	Up to 3 years	No