Early Intervention With the Marte Meo Method

Health Behavior Clinical Trial

— TiMM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799447
• Other study ID #: TiMM, AU, NN, FiM
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: May 3, 2017
• Start date: May 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Weeks to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior
• Mother-Child Relations

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus university	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Novo Nordisk A/S, Region MidtJylland Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant CARE-Index	Infant care index coding of videorecordings of mother and infant	6 months after delivery
Primary	Child ASQ:SE	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	Maternal stress (PSS) and confidence (KPCS)	Validated PSS and KPCS	3 months after delivery and 6 months after delivery