NCT01799447

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4.5 years

First QC Date

February 6, 2013

Last Update Submit

May 3, 2017

Conditions

Keywords

Early interventionIntervention studyInfant mother relationsFirst time mothersParental programMarte Meo methodVideo guidances

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maternal stress (PSS) and confidence (KPCS)

    3 months after delivery and 6 months after delivery

Other Outcomes (1)

  • Infant CARE-Index

    6 months after delivery

Study Arms (1)

Early intervention

OTHER

Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group.

Behavioral: Early intervention

Interventions

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

Also known as: Video gudiance with the Marte Meo method, Relations between infants and vulnerable first times mothers
Early intervention

Eligibility Criteria

Age7 Weeks - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Mothers severe at risk, if they has been refereed to other departments than health nurses for treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus university

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Health Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 26, 2013

Study Start

May 1, 2012

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations