Long-term Effect of The Mother Infant Transaction Program (MITP) (2007/2/0150)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00903149
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : March 30, 2016
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Nina Margrethe Kynø, Oslo University Hospital

Brief Summary:

The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age.

Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment.

Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.

Condition or disease
Premature Births

Detailed Description:

A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year.

This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age.

The research questions are:

  1. Can a psychoeducative program like the MITP influence the childrens` development in various aspects?
  2. How did the MITP influence the parents experience of concern and stress three years later?
  3. Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group

The questionnaires to be used in this observational study are:

Ages and Stages

Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Official Title: Long-term Effect of The Mother Infant Transaction Program (MITP)
Study Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : January 2012

MITP exposure or not
Mothers of children born preterm and term.

Primary Outcome Measures :
  1. Child development [ Time Frame: 36 months ]
  2. Parenting stress [ Time Frame: Child age 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Months to 37 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in control groups.

Inclusion Criteria:

  • All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.

Responsible Party: Nina Margrethe Kynø, PhD, Oslo University Hospital Identifier: NCT00903149     History of Changes
Other Study ID Numbers: 977468299
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Nina Margrethe Kynø, Oslo University Hospital:
Premature babies
Social interaction
Psychoeducative intervention
Mother Infant Transaction Program
Three years follow-up
Late preterm
Cognitive development
Social development
Emotional development
Motor development
Children born preterm and their parents

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