- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799447
Early Intervention With the Marte Meo Method (TiMM)
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aarhus, Denmark, 8000
- Aarhus University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child ASQ:SE
Time Frame: 3 month and 6 months
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Maternal self reported questionnaire when the child is 3 months old and when the child is 6 months old.
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3 month and 6 months
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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
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Validated PSS and KPCS
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3 months after delivery and 6 months after delivery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant CARE-Index
Time Frame: 6 months after delivery
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Infant care index coding of videorecordings of mother and infant
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6 months after delivery
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TiMM, AU, NN, FiM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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