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

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.

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Key information

Conditions

Premature Births Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

35 month–37 month

Sex eligibility

All sexes

Study type

Observational

About this study

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:

Can a psychoeducative program like the MITP influence the childrens' development in various aspects?
How did the MITP influence the parents experience of concern and stress three years later?
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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Child development

Time frame: 36 months
Parenting stress

Time frame: Child age 36 months

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

Norwegian Foundation for Health and Rehabilitation

Registry information

Acronym: 2007/2/0150

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2012
First posted: May 18, 2009
Registry last updated: Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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