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

Premature Births Clinical Trial

— 2007/2/0150  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903149
• Other study ID #: 977468299
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: March 29, 2016
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: March 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Months to 37 Months

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Premature Birth
• Premature Births

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Foundation for Health and Rehabilitation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child development		36 months	No
Primary	Parenting stress		Child age 36 months	No