Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants in the First Year of Life

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Royal Norwegian Ministry of Health
Regionsenter for barn og unges psykiske helse
Norwegian Nurses Association (NSF)
University of Oslo
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00245843
First received: October 27, 2005
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to investigate if the effects of the Vermont intervention, implemented by nurses in a Neonatal Intensive Care Unit (NICU), can influence social interaction and joint attention skills between parents and preterm babies in the second half of the first year of life.


Condition Intervention
Premature Birth
Behavioral: Mother Infant Transaction Program (MITP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants Int the First Year of Life

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life [ Time Frame: 1, 4, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Child outcome: child's quality and social capacity for joint attention/social interaction [ Time Frame: 1,4, 9 and 12 months ] [ Designated as safety issue: No ]
  • Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress [ Time Frame: 1, 4, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child outcomes: child development, child temperament, growth [ Time Frame: 1, 4, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Parenting outcome: depression, stress, maternal confidence [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: January 2005
Estimated Study Completion Date: February 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mother Infant Transaction Program (MITP)
    Psychosocial intervention. 11-session one hour standardized intervention program. The aim of the MITP is to help parents to appreciate their infant's unique characteristics,temperament and developmental potential.
Detailed Description:

The bases of parental sensitivity and infants' joint attention skills are probably established during the child's first year of life. Research suggests that the quality of early social interaction is related to children's later development and mental health. Preterm infants are at risk for developing interaction disturbances in the first year of life, and such aberrancies often lay the foundation for later problems of adaptation. Following preterm birth the infant is exposed to an atypical extra uterine environment. In such an environment it is hard for an immature brain to modulate the infant's behaviour properly.

Under such circumstances there are several factors to consider. The disturbances that may be seen later may be mediated and moderated by the infant's state, parental circumstances and conditions in the hospital environment. Parents of preterm infants experience interruption of normal pregnancy and may be in a difficult emotional state after preterm birth, and often they are not prepared for their role as parents. They are also vulnerable to stress and worries concerning survival of their baby. These conditions are assumed to have a negative influence on the social interaction between preterm infant and parents, and can make it difficult for the caretakers to adapt to their low birth weight infant and to engage in social interaction with their baby.

The purpose of this study is to evaluate the effects of a neonatal intervention program (Vermont-intervention) on parental sensitivity and the interaction skills between parents and preterm babies in the first year of life. The intervention is based on a transactional model of development, which emphasizes the mutual regulation and interaction going on between a child and its caretakers over time.

The study is a randomized controlled trial in a NICU environment. 100 preterm children born between 30 and 36 weeks of gestation are randomly assigned to a control group and an experimental group. The intervention is the Mother Infant Transaction Program (MITP) called the Vermont intervention. In addition, 50 full term normal-weight infants are recruited into a full term control group. The work of recruitment and randomizing of the 150 families to the three groups is carried out by a paediatric research assistant who will also be responsible for the organization and implementation of the interventions at hospital and at home after discharge from hospital. To the extent it is possible, the nurse researcher is not supposed to recognize the group identity of the participants in the three groups when administering questionnaires and scoring video recordings of social interaction and joint attention between mother and child at ages 6, 9 and 12 months.

  Eligibility

Ages Eligible for Study:   30 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Preterm newborns with gestational age > 29.6 and < 36.0 weeks at birth.
  • Full term newborns with gestational age > 36.9 weeks at birth and birth weight equal to or more than 2500 grams
  • Admitted to Ullevål University Hospital
  • Families are recruited to the study before infants are discharged from the hospital

Exclusion Criteria:

  • Congenital or chromosomal abnormality, and/or severe neonatal diseases
  • History of maternal substance or psychiatric disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245843

Locations
Norway
Ullevaal University Hospital (UUS)
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Royal Norwegian Ministry of Health
Regionsenter for barn og unges psykiske helse
Norwegian Nurses Association (NSF)
University of Oslo
Investigators
Study Director: Rolf Lindemann, MD, PhD Ullevål University Hospital (UUS)
  More Information

No publications provided by Ullevaal University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: South-Eastern Norway Regional Health Authority, South-Eastern Norway Regional Health authority
ClinicalTrials.gov Identifier: NCT00245843     History of Changes
Other Study ID Numbers: Vermont
Study First Received: October 27, 2005
Last Updated: March 31, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Premature birth
moderate preterm
late preterm
Joint attention
Social interaction
Child development
Parent
infant

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 19, 2014