AzTrials
AzTrials

FamilyMTBNCT03495895

The Effectiveness of MInding the Baby in a Danish Community Sample

A study testing Minding the Baby in people with Family and Pregnancy, High Risk, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Read more about this study

Who is it for?
Ages 15 years and older, women only
Conditions the study is for
Family, Pregnancy, High Risk
What is being tested?
Minding the Baby
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteDenmark
Study dates
10 Jun 2018to 1 Aug 2024
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 15 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant vulnerable women

Who cannot join

  • Current severe substance abuse
  • Severe psychotic illness
  • Profound or severe learning disabilities
  • Life-threatening illness in parent or child
  • Non-Danish speaking

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • VIVE - The Danish Centre of Applied Social Science

    Copenhagen, 1052

Other trials in Denmark

About this study

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.

Read the detailed description

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old.

The effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark.

Being tested
Minding the Baby, Usual Care
Keywords
Disadvantaged families, Pregnancy, Intervention, Minding the Baby

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minding the BabyBehavioural

    Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.

  • Usual CareBehavioural

    Usual care condition

Study groups in NCT03495895
Study groupRoleWhat they receive
Minding the BabyExperimentalFamilies are visited weekly beginning in the mother's third trimester of pregnancy up through the child's first birthday, at which point visits take place biweekly up through the child's second birthday.
Receives: Behavioral: Minding the Baby
ControlOtherUsual care control condition. Families in the control Group receive the usual care that is offered to families in the target group
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Maternal sensitivity

    Measured: at child age 24 months

Secondary outcomes (17)

  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Maternal sensitivity

    Measured: Child age 12 months

  2. Coding interactive bahavior (CIB)

    Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states

    Measured: child age 12 and 24 months

  3. Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)

    Child social-emotional Development Total score range 0-150 ( 3 months 15 items), 0-260 (12 months 26 items), 0-300 (24 months 30 items). Low score is better.

    Measured: 3, 12 and 24 months

  4. Edinburgh Postnatal depression Scale (EPDS)

    Depression Total score range 0-30. Low score is better

    Measured: 3, 12 , 24 months

  5. Warwick-Edinburgh Mental Well-being Scale

    Maternal mental Health 7 items. A total score i calculated by summing the 7 items and converting the raw score according to a published conversion table. Raw score range 7- 35. Converted score range 7-35. High is better outcome.

    Measured: Baseline, 3, 12 , 24 months

  6. 2-5

    The name of the measure is 2-5 and measures child Development. Subscales included: Perception (7 items) low score is better, Language (10 items) low score is better

    Measured: 24 months

  7. Prenatal Parental reflective functioning questionnaire (P-PRFQ)

    Parental reflective functioning for pregnant women. Total score range 14-98. Higher score is better. Three subscales: Opacity of mental states (4 items), reflecting on the fetus-baby (3 items) and Dynamic of mental states (5 items)

    Measured: Baseline

  8. Parental reflective functioning questionnaire (PRFQ-1)

    Parental reflective functioning Three subscales score range 6-42: Pre-Mentalizing Modes (PRFQ-PM) 6 items. low score is better. Certainty about Mental States (PRFQ-CMS) 6 items high score is better. Interest and curiosity in mental states PRFQ-IC 6 items high score is better.

    Measured: 12 and 24 months

  9. Parental Stress Scale (PSS)

    Parental stress Total score range 18-90 low score is better

    Measured: 12 ,24 months

  10. Ages and Stages Questionnaire 3 (ASQ:3)

    Child development

    Measured: 3 months

  11. Acitvities with child

    Singing and reading Total score range 0-70. High score is better.

    Measured: 12 and 24 months

  12. SEAM Family profile

    Family profile

    Measured: 12 months

  13. Parent behavior Inventory (PBI)

    Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.

    Measured: 12 and 24 months

  14. Being a Mother (BAM-13)

    Maternal confidence. Total score range 0-39. Low score is better

    Measured: 3 months

  15. Hospital Anxiety and Depression Scale (HADS)

    Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)

    Measured: Baseline, 3, 12,24 months

  16. PTSD-8

    A Short PTSD Inventory. Total score range 8-32, low score is better

    Measured: Baseline, 12 and 24 months

  17. Experiences in Close Relationship Scale-Short Form (ECR-S)

    Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)

    Measured: Baseline, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start10 Jun 2018
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495895
Sponsor's protocol ID
VIVE
Acronym
MTB
Status last verified
Nov 2024
First submitted
30 Jan 2018
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There will be few participants from each local authority and data can therefore not be made publicly available due to protect participant privacy

Publications

  • Pontoppidan M, Hirani JC, Friis-Hansen M. Minding the Baby versus usual care: effects on parental sensitivity and parent-child interaction in a cluster quasi-randomized trial. Attach Hum Dev. 2025 Aug;27(4):567-590. doi: 10.1080/14616734.2025.2534608. Epub 2025 Jul 28.

    PubMed 40717494

  • Pontoppidan M, Thorsager M, Friis-Hansen M, Slade A, Sadler LS. Minding the Baby versus usual care: study protocol for a quasi-cluster-randomized controlled study in Denmark of an early interdisciplinary home-visiting intervention for families at increased risk for adversity. Trials. 2022 Jun 24;23(1):529. doi: 10.1186/s13063-022-06434-2.

    PubMed 35751089

Questions about this trial

What is this clinical trial studying?

A study testing Minding the Baby in people with Family and Pregnancy, High Risk, run by VIVE - The Danish Center for Social Science Research 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 1 inclusion and 5 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 13 Nov 2024. 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?

Maternal sensitivity measured by the CIB (Coding Interactive Behavior) (time frame: at child age 24 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 NCT03495895, which also lists 2 linked publications.

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 13 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in