Health BehaviorTiMMNCT01799447
Early Intervention With the Marte Meo Method
A study testing Early intervention in people with Health Behavior and Mother-Child Relations, run by University of Aarhus at 1 site in Denmark.
Trial 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) Read more about this study
- Who is it for?
- Ages 7 weeks to 6 months
- Conditions the study is for
- Health Behavior, Mother-Child Relations
- What is being tested?
- Early intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Mothers severe at risk, if they has been refereed to other departments than health nurses for treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- Health Behavior, Mother-Child Relations
- Being tested
- Early intervention
- Keywords
- Early intervention, Intervention study, Infant mother relations, First time mothers, Parental program, Marte Meo method, Video guidances
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early interventionBehavioural
Also called Video gudiance with the Marte Meo method, Relations between infants and vulnerable first times mothers
Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Other | Early intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group. Receives: Behavioral: Early intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child ASQ:SE
Maternal self reported questionnaire when the child is 3 months old and when the child is 6 months old.
Measured: 3 month and 6 months
Secondary outcomes (1)
Maternal stress (PSS) and confidence (KPCS)
Validated PSS and KPCS
Measured: 3 months after delivery and 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Region MidtJylland Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799447
- Sponsor's protocol ID
- TiMM, AU, NN, FiM
- Acronym
- TiMM
- Status last verified
- May 2017
- First submitted
- 6 Feb 2013
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29141587
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01799447
- Acronym / sponsor ID
- TiMM / TiMM, AU, NN, FiM
- Conditions
- Health Behavior, Mother-Child Relations
- Keywords
- Early intervention, Intervention study, Infant mother relations, First time mothers, Parental program, Marte Meo method, Video guidances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Region MidtJylland Denmark
- Study start
- May 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Other | Behavioral: Early interventionEarly intervention. Quasiexperimental study. Inclusion of 150 first times families in intervention and matched with 150 families from control group. |
Who may qualify
- Ages
- 7 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Mothers severe at risk, if they has been refereed to other departments than health nurses for treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early interventionAlso: Video gudiance with the Marte Meo method, Relations between infants and vulnerable first times mothersInterventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants. | Behavioural | Early intervention |
Primary outcome
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.
1 secondary outcome
Maternal stress (PSS) and confidence (KPCS)
Time frame: 3 months after delivery and 6 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Derived from this study: PubMed 29141587Kristensen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Health Behavior
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruiting
Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren
Physical Fitness, Health
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention in people with Health Behavior and Mother-Child Relations, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child ASQ:SE (time frame: 3 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.