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

NCT ID: NCT00903149

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-01-31

Brief 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.

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

Conditions

Premature Births

Study Design

• Observational Model Type: COHORT

Study Groups

MITP exposure or not

Mothers of children born preterm and term.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 35 Months
• Maximum Eligible Age: 37 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nina Margrethe Kynø

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

977468299

Identifier Type: -

Identifier Source: org_study_id