Early Intervention With the Marte Meo Method (TiMM)

May 3, 2017 updated by: University of Aarhus

The Relations Between Infants and Vulnerable First Time Mothers. Does Video Guidances With the Marte Meo Method Promote the Process? Intervention Study in a Community Setting

Early intervention with the Marte Meo method. Aim to study whether the program have effect on:

Maternal confidence, maternal stress, maternal mood (EPDS), dyadic synchrony (Infant care index), and infants social competences (ASQ:SE)

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Relations between infant and vulnerable first time's mothers - Does video guidance with the Marte Meo method promote the process? Intervention study in a community setting

Background Infants develop their mentality, social and psychologically competencies in relations with parents and sensitive and responsive caregiving is important for infant's healthy development. Maternal responsiveness defined as the mother's ability to recognise infant's cues and act on those is a key to promote a secure child. At risk are unsecure/uncertain mothers, postpartum depressed mothers, mothers with preterm children and infants who in the perspective of the mother cries persistent and/or does not sleep well.

Danish public health nurses do home-visiting parents and they have opportunity to support parents in the development of relations to the infants. Some nurse's uses video-guidance with the Marte Meo method to promote the development of a healthy parent-infant relations, but knowledge about the effect of parent's having received video-guidance with the method is lacking.

Study part 1 Aim: To develop a screening tool to help public health nurses to identify unsecure mothers.

Design: Intervention Mapping step 1. Need assessment and development of few questions as a screening tool. Test of questions by face and content validation.

Study part 2 Develop a standardised preventive program step 2-4 in Intervention Mapping. The intervention is done by public health nurses, in home visits to first times mothers in the period from the child 2 to 6 months aged. The intervention includes 2-5 home visits with video-guidance's and has focus on the mother's ability to recognise infant's cues and act on those.

Excluded are families at sever risk who have been referred to treatment by psychiatric, psychological or social apartment.

Study 3 Test the program. Goal: to promote mothers parental self-efficacy, minimise mother's stress and mother's depressive mood. To promote infants social competences and promote mothers responsiveness and interaction with the infant.

Design: Quasi-experimental design. The intervention within 5 municipals with 36 "interventions public health nurses" (having a 1 ½ year educations as a Marte Meo therapist) and 85 "control public health nurses" who works as usually. The intervention group will includes 60 families and they will be matches with 60 families from the control groups.

Test: All first times mothers in the 5 municipals, when the children are 8 weeks old and after the intervention has stopped, when the children are 6 months old.

Test: All public health nurses when the interventions start and when the intervention stops.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First time mothers with children 7,8,9 weeks old.
  • Mothers with EPDS from 8 to 13.
  • Mothers who have delivered moderate to early between 32 and 37 weeks.
  • And mothers with low maternal confidence

Exclusion Criteria:

  • Mothers severe at risk, if they has been refereed to other departments than health nurses for treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early intervention
Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group.
Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.
Other Names:
  • Video gudiance with the Marte Meo method
  • Relations between infants and vulnerable first times mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child ASQ:SE
Time Frame: 3 month and 6 months
Maternal self reported questionnaire when the child is 3 months old and when the child is 6 months old.
3 month and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal stress (PSS) and confidence (KPCS)
Time Frame: 3 months after delivery and 6 months after delivery
Validated PSS and KPCS
3 months after delivery and 6 months after delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant CARE-Index
Time Frame: 6 months after delivery
Infant care index coding of videorecordings of mother and infant
6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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