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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

Tracking Information
First Submitted Date  ICMJE February 6, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date May 4, 2017
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
Child ASQ:SE [ Time Frame: 3 month and 6 months ]
Maternal self reported questionnarie when the child is 3 months old and when the child is 6 months old.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
Maternal stress (PSS) and confidence (KPCS) [ Time Frame: 3 months after delivery and 6 months after delivery ]
Validated PSS and KPCS
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
Maternal mood EPDS [ Time Frame: 3 months after delivery and 6 months after delivery ]
EPDS is used as a predictor and as outcome measures
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2015)
Infant CARE-Index [ Time Frame: 6 months after delivery ]
Infant care index coding of videorecordings of mother and infant
Original Other Pre-specified Outcome Measures
 (submitted: February 25, 2013)
Maternal responsiveness Infant care index [ Time Frame: 6 months after delivery ]
Infant care index coding of videorecordings of mother and infant
 
Descriptive Information
Brief Title  ICMJE Early Intervention With the Marte Meo Method
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Health Behavior
  • Mother-Child Relations
Intervention  ICMJE 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
Study Arms  ICMJE Early intervention
Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group.
Intervention: Behavioral: Early intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Weeks to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799447
Other Study ID Numbers  ICMJE TiMM, AU, NN, FiM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Novo Nordisk A/S
  • Region MidtJylland Denmark
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP