Early Behavioral Intervention for Preterm Infants (EBI)

July 26, 2016 updated by: Martha G. Welch, MD, Columbia University

FNI Between Mothers and Preschool Age Children

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10032
        • Columbia University Medical Center - Nuture Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family Nurture Intervention Group
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.
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.
Other Names:
  • FNI
Active Comparator: Play and Nutrition Intervention Group
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.
Behavioral: 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.
Other Names:
  • PNI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Behavior Checklist (CBCL) Scale
Time Frame: Baseline, 5 weeks, 6 months, 12 months
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary Cortisol Level
Time Frame: Up to 3 years
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
Oxytocin (OT) Level
Time Frame: Up to 3 years
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
Variance in Vagal Tone (High Frequency Heart Period Variability)
Time Frame: Up to 3 years
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
Strengths and Difficulties Questionnaire (SDQ) Score
Time Frame: Up to 3 years
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
Sleep Habits Questionnaire (SHQ) Score
Time Frame: Up to 3 years
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
State-Trait Anxiety Inventory (STAI) Scale
Time Frame: Up to 3 years
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
Parenting Stress Index (PSI) Scale
Time Frame: Up to 3 years
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
Center for Epidemiologic Studies Depression (CES-D) Score
Time Frame: Up to 3 years
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
Maternal Self Efficacy Scale
Time Frame: Up to 3 years
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
Norbeck Social Support Questionnaire (NSSQ) Score
Time Frame: Up to 3 years
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
Mom's Support Circle Scale
Time Frame: Up to 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert J Ludwig, BA, Lab Manager, Nurture Science Progam, Columbia University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAO2957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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