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

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ClinicalTrials.gov Identifier: NCT00245843
Recruitment Status : Unknown
Verified March 2009 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2005
Last Update Posted : April 1, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Premature Birth Behavioral: Mother Infant Transaction Program (MITP)

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants Int the First Year of Life
Study Start Date : January 2005
Primary Completion Date : February 2008
Estimated Study Completion Date : February 2010
Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Child outcome: child's quality and social capacity for joint attention/social interaction [ Time Frame: 1,4, 9 and 12 months ]
  3. Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress [ Time Frame: 1, 4, 6, 9 and 12 months ]

Secondary Outcome Measures :
  1. Child outcomes: child development, child temperament, growth [ Time Frame: 1, 4, 6, 9 and 12 months ]
  2. Parenting outcome: depression, stress, maternal confidence [ Time Frame: 1, 6 and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Weeks and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245843

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
Study Director: Rolf Lindemann, MD, PhD Ullevål University Hospital (UUS)
More Information

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
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

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

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