Expired Study
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New York City, New York 10032


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

AAAO2957


NCT ID:

NCT02379130


Secondary ID:


Study Acronym:

EBI


Brief Title:

Early Behavioral Intervention for Preterm Infants


Official Title:

FNI Between Mothers and Preschool Age Children


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

30 Months


Maximum Age:

40 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Insufficient enrollment/retention


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert J Ludwig, BA
Study Director
Lab Manager, Nurture Science Progam, Columbia University Medical Center

Study Dates

Start Date:February 2015
Completion Date:May 2016
Completion Type:Actual
Primary Completion Date:May 2016
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 26, 2016
First Received Date:February 25, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mom's Support Circle Scale
Time Frame:Up to 3 years
Safety Issues:False
Description: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, frien
Outcome Type:Secondary Outcome
Measure:Norbeck Social Support Questionnaire (NSSQ) Score
Time Frame:Up to 3 years
Safety Issues:False
Description: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 des
Outcome Type:Secondary Outcome
Measure:Maternal Self Efficacy Scale
Time Frame:Up to 3 years
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Center for Epidemiologic Studies Depression (CES-D) Score
Time Frame:Up to 3 years
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Parenting Stress Index (PSI) Scale
Time Frame:Up to 3 years
Safety Issues:False
Description: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/Hyp
Outcome Type:Secondary Outcome
Measure:State-Trait Anxiety Inventory (STAI) Scale
Time Frame:Up to 3 years
Safety Issues:False
Description: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 sensi
Outcome Type:Secondary Outcome
Measure:Sleep Habits Questionnaire (SHQ) Score
Time Frame:Up to 3 years
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Strengths and Difficulties Questionnaire (SDQ) Score
Time Frame:Up to 3 years
Safety Issues:False
Description: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 beha
Outcome Type:Secondary Outcome
Measure:Variance in Vagal Tone (High Frequency Heart Period Variability)
Time Frame:Up to 3 years
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure:Oxytocin (OT) Level
Time Frame:Up to 3 years
Safety Issues:False
Description: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 e
Outcome Type:Secondary Outcome
Measure:Salivary Cortisol Level
Time Frame:Up to 3 years
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Child Behavior Checklist (CBCL) Scale
Time Frame:Baseline, 5 weeks, 6 months, 12 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Behavioral
Name:Family Nurture Intervention
Description: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
Arm Name:Family Nurture Intervention Group
Other Name:FNI
Intervention Type:Behavioral
Name:Play and Nutrition Intervention
Description: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.
Arm Name:Play and Nutrition Intervention Group
Other Name:PNI

Study Arms

Study Arm Type:Active Comparator
Arm Name:Play and Nutrition Intervention 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
Study Arm Type:Experimental
Arm Name:Family Nurture Intervention 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 famil

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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