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Trial record 1 of 1 for:    01799447
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Early Intervention With the Marte Meo Method (TiMM)

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ClinicalTrials.gov Identifier: NCT01799447
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Novo Nordisk A/S
Region MidtJylland Denmark
Information provided by (Responsible Party):
University of Aarhus

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)


Condition or disease Intervention/treatment Phase
Health Behavior Mother-Child Relations Behavioral: Early intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Early intervention
Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group.
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.
Other Names:
  • Video gudiance with the Marte Meo method
  • Relations between infants and vulnerable first times mothers




Primary Outcome Measures :
  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 Outcome Measures :
  1. Maternal stress (PSS) and confidence (KPCS) [ Time Frame: 3 months after delivery and 6 months after delivery ]
    Validated PSS and KPCS


Other Outcome Measures:
  1. Infant CARE-Index [ Time Frame: 6 months after delivery ]
    Infant care index coding of videorecordings of mother and infant



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Ages Eligible for Study:   7 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799447


Locations
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Denmark
Aarhus university
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
Region MidtJylland Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01799447     History of Changes
Other Study ID Numbers: TiMM, AU, NN, FiM
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Aarhus:
Early intervention
Intervention study
Infant mother relations
First time mothers
Parental program
Marte Meo method
Video guidances