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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00245843
• Other study ID #: Vermont
• Status: Active, not recruiting
• Phase: N/A
• First received: October 27, 2005
• Last updated: March 31, 2009
• Start date: January 2005
• Est. completion date: February 2010

Study information

• Verified date: March 2009
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: February 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Weeks and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital (UUS)	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Nurses Association (NSF), Regionsenter for barn og unges psykiske helse, The Royal Norwegian Ministry of Health, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social interaction and joint attention skills between parents and moderate/late preterm infants within first year of life		1, 4, 6, 9 and 12 months	No
Primary	Child outcome: child's quality and social capacity for joint attention/social interaction		1,4, 9 and 12 months	No
Primary	Parenting outcome: parents' sensitivity/responsitivity to children's behaviour/signals, parental stress		1, 4, 6, 9 and 12 months	No
Secondary	Child outcomes: child development, child temperament, growth		1, 4, 6, 9 and 12 months	No
Secondary	Parenting outcome: depression, stress, maternal confidence		1, 6 and 12 months	No