Long-term Effect of The Mother Infant Transaction Program (MITP)

Completed

• Conditions: Premature Births

• Registration Number: NCT00903149
• Lead Sponsor: Ullevaal 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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Primary Completion: 2010-02
• Study Completion: 2012-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Child development	36 months
Parenting stress	Child age 36 months