Early Intervention With the Marte Meo Method (TiMM)

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

Tracking Information

• First Submitted Date: February 6, 2013
• First Posted Date: February 26, 2013
• Last Update Posted Date: May 4, 2017
• Actual Study Start Date: May 2012
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Early Intervention With the Marte Meo Method
• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• 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.

Other Names:

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

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2013): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Weeks to 6 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01799447
• Other Study ID Numbers: TiMM, AU, NN, FiM
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: University of Aarhus
• Study Sponsor: University of Aarhus

Collaborators

• Novo Nordisk A/S
• Region MidtJylland Denmark

• Investigators: Not Provided
• PRS Account: University of Aarhus
• Verification Date: May 2017