Early Intervention With the Marte Meo Method

NCT ID: NCT01799447

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-12-31

Brief Summary

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)

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.

Conditions

Health Behavior; Mother-Child Relations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early intervention

Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group.

Group Type: OTHER

Early intervention

Intervention Type: BEHAVIORAL

Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.

Interventions

Early intervention

Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.

Intervention Type: BEHAVIORAL

Other Intervention Names

Video gudiance with the Marte Meo method; Relations between infants and vulnerable first times mothers

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Weeks
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Region MidtJylland Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus university

Aarhus, , Denmark

Countries

Denmark

References

Kristensen IH, Simonsen M, Trillingsgaard T, Kronborg H. Video feedback promotes relations between infants and vulnerable first-time mothers: a quasi-experimental study. BMC Pregnancy Childbirth. 2017 Nov 15;17(1):379. doi: 10.1186/s12884-017-1568-1.

Reference Type: DERIVED

PMID: 29141587 (View on PubMed)

Other Identifiers

TiMM, AU, NN, FiM

Identifier Type: -

Identifier Source: org_study_id