Skip to main content
OpenTrials
Completed

NCT Number: NCT01799447

Early Intervention With the Marte Meo Method

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)

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus university

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maternal stress (PSS) and confidence (KPCS)

    Time frame: 3 months after delivery and 6 months after delivery

    Validated PSS and KPCS

Other outcomes

  1. Infant CARE-Index

    Time frame: 6 months after delivery

    Infant care index coding of videorecordings of mother and infant

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Novo Nordisk A/S
  • Region MidtJylland Denmark

Registry information

Official study title

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

Acronym: TiMM

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2013
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.