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

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Nina Margrethe Kynø, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00903149
First received: May 6, 2009
Last updated: March 29, 2016
Last verified: March 2016
  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:

Primary Outcome Measures:
  • Child development [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Parenting stress [ Time Frame: Child age 36 months ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: January 2007
Study Completion Date: January 2012
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

Responsible Party: Nina Margrethe Kynø, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00903149     History of Changes
Other Study ID Numbers: 977468299 
Study First Received: May 6, 2009
Last Updated: March 29, 2016
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 Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on May 04, 2016