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Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Cohort


Related Conditions & MeSH terms


NCT number NCT00903149
Study type Observational
Source Oslo University Hospital
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date January 2012