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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MITP exposure or not; Mothers of children born preterm and term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child development	36 months
Parenting stress	Child age 36 months

Collaborators and Investigators

• Sponsor: Ullevaal University Hospital
• Collaborators: Norwegian Foundation for Health and Rehabilitation

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 6, 2009
• First Submitted That Met QC Criteria: May 14, 2009
• First Posted (Estimate): May 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Cognitive development; Motor development; Social interaction; Premature babies; Psychoeducative intervention; Mother Infant Transaction Program; Three years follow-up; Late preterm; Social development; Emotional development; Children born preterm and their parents
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 977468299