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

October 27, 2005
March 31, 2009
January 2005
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Social interaction and joint attention skill between parents and preterm babies within first year of life.
  • Child outcomes: Childs quality and social capacity for joint attention/ social interaction.
  • Parenting outcome: Parents sensitivity/ responsitivity to children’s behaviour/signals
Complete list of historical versions of study NCT00245843 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Child outcomes: Child development. Child temperament. Growth.
  • Parenting outcome: Depression. Stress. Maternal confidence.
Not Provided
Not Provided
 
Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants in the First Year of Life
Vermont Intervention: Effect on Joint Attention Skills Between Parents and Moderate/Late Preterm Infants Int the First Year of Life

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Premature Birth
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
February 2010
February 2008   (final data collection date for primary outcome measure)

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.
Both
30 Weeks and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00245843
Vermont
Yes
South-Eastern Norway Regional Health Authority, South-Eastern Norway Regional Health authority
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)
Ullevaal University Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP