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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00903149
First received: May 6, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition
Premature Births

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Long-term Effect of The Mother Infant Transaction Program (MITP)

Further study details as provided by Oslo University Hospital:

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
MITP exposure or not
Mothers of children born preterm and term.

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

  Eligibility

Ages Eligible for Study:   35 Months to 37 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Nina M. Kyno, PhD student, OSLO University Hospital Ullevaal
ClinicalTrials.gov Identifier: NCT00903149     History of Changes
Other Study ID Numbers: 977468299
Study First Received: May 6, 2009
Last Updated: July 20, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Premature babies
Social interaction
Psychoeducative intervention
Mother Infant Transaction Program
Three years follow-up
Late preterm
Cognitive development
Social development
Emotional development
Motor development
Children born preterm and their parents

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 21, 2014