First-time Mothers and Their PartnersNCT03991416
Understanding Your Baby: A Parallel Group Study of a Universal Parenting Support Program
A study testing Understanding Your Baby and Postnatal care as usual in people with First-time Mothers and Their Partners, run by University of Copenhagen at 1 site in Denmark.
Trial summary
In Understanding Your Baby first-time parents receive research-based knowledge on how to interpret their infants' socioemotional needs based on their behavior, and how to meet their infants' socioemotional needs in accordance with their developmental stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First-time Mothers and Their Partners
- What is being tested?
- Understanding Your Baby and Postnatal care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,737 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2019to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time mother or father/partner
- Singleton pregnancy
- Mother living together with the baby
- Mother living in the Danish municipalities of Køge, Hvidovre, Høje-Taastrup, Frederiksberg, Lolland, Holbæk, Næstved, Middelfart, Nyborg or Aalborg.
- Understands Danish or English
Who cannot join
- Under the age of 18 when the child is born
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Copenhagen, 1353
About this study
Official title: Understanding Your Baby: A Universal Parenting Support Program Aiming at Increasing Danish First Time Parents' Abilities for Understanding and Meeting Their Infants' Needs
In Understanding Your Baby first-time parents receive research-based knowledge on how to interpret their infants' socioemotional needs based on their behavior, and how to meet their infants' socioemotional needs in accordance with their developmental stage. This information is delivered to parents at routine home visits by public health nurses, who are trained in the research base behind the program, and using cue cards and short video clips, which concretely exemplify how infants signal their socioemotional needs and inspire to positive activities between parents and their infants.
The aim of Understanding Your Baby is to support infant socioemotional development by increasing parents' abilities at perceiving, understanding, and responding to their infant's socioemotional signals. Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual and Understanding Your Baby. The primary outcome is parental sense of competence and secondary outcomes are parental stress and child socioemotional development.
- Conditions
- First-time Mothers and Their Partners
- Being tested
- Understanding Your Baby, Postnatal care as usual
- Keywords
- Universal, Prevention, Parental competence, Socioemotional, Public health nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understanding Your BabyBehavioural
Also called Forstaa din baby
Research-based knowledge on the understanding and meeting of the baby's socioemotional needs is delivered to the parents systematically by public health visitors based on a manual, cue cards, and video clips at four time points from 1 to 10 months postpartum.
Postnatal care as usualBehavioural
In accordance with Danish national guidelines, health visitors visit families during the infants first year of life, where they weigh and measure the infant. Further, they offer individual guidance and support regarding for instance feeding, sleeping, how to stimulate the infant, and the developmental stages that the infant goes through.
| Study group | Role | What they receive |
|---|---|---|
| Understanding Your Baby | Experimental | Understanding Your Baby plus postnatal care as usual Receives: Behavioral: Understanding Your Baby |
| Care As Usual | Active comparator | Postnatal care as usual Receives: Behavioral: Postnatal care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Parenting Competence
Maternal Parenting Competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
Measured: T4 (infant age 11-11.5 months)
Secondary outcomes (6)
Maternal and Paternal Parenting Competence
Maternal and paternal parenting competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
Measured: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)
Maternal and Paternal Parenting Stress
Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).
Measured: T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
Maternal and Paternal Parental Mentalizing
Maternal and paternal parental mentalizing is assessed via self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, \& Fonagy, 2017).
Measured: T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Maternal and Paternal Mind-Mindedness
Maternal and paternal mind-mindedness are assessed using a written response to the first question from the "Describe you child" interview (Meins et al., 1998). Mind-mindedness is coded according to the criteria specified in the mind-mindedness coding manual (Meins \& Fernyhough, 2015).
Measured: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Maternal, paternal and child screen use
Maternal, paternal and child screen use is measured using a questionnaire developed specifically for this research project.
Measured: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Infant socio-emotional development
Infant socio-emotional development is assessed via parental report using the Ages \& Stages Questionnaires®: Social-Emotional, Second Edition (ASQ:SE-2; Squires, Bricker, \& Twombly, 2015).
Measured: T4 (infant age 11-11.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start15 May 2019
- Primary completion30 Sep 2022
- Study completion31 Dec 2025
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 First-time Mothers and Their PartnersStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,737 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Nordea-fonden
- Responsible party
- Principal investigator, Mette Væver, University of Copenhagen
- Investigators
- Mette S. Væver, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991416
- Sponsor's protocol ID
- UCPH 2019-02
- Status last verified
- May 2026
- First submitted
- 28 Feb 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaever MS, Krogh MT, Stuart AC, Madsen EB, Haase TW, Egmose I. Understanding Your Baby: protocol for a controlled parallel group study of a universal home-based educational program for first time parents. BMC Psychol. 2022 Sep 22;10(1):223. doi: 10.1186/s40359-022-00924-3.
PubMed 36138482
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Your Baby: A Universal Parenting Support Program Aiming at Increasing Danish First Time Parents' Abilities for Understanding and Meeting Their Infants' Needs
- ClinicalTrials.gov ID
- NCT03991416
- Acronym / sponsor ID
- UCPH 2019-02
- Conditions
- First-time Mothers and Their Partners
- Keywords
- Universal, Prevention, Parental competence, Socioemotional, Public health nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,737 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Nordea-fonden
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Jun 2019 (actual)
- 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.
In Understanding Your Baby first-time parents receive research-based knowledge on how to interpret their infants' socioemotional needs based on their behavior, and how to meet their infants' socioemotional needs in accordance with their developmental stage. This information is delivered to parents at routine home visits by public health nurses, who are trained in the research base behind the program, and using cue cards and short video clips, which concretely exemplify how infants signal their socioemotional needs and inspire to positive activities between parents and their infants.
The aim of Understanding Your Baby is to support infant socioemotional development by increasing parents' abilities at perceiving, understanding, and responding to their infant's socioemotional signals. Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual and Understanding Your Baby. The primary outcome is parental sense of competence and secondary outcomes are parental stress and child socioemotional development.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Understanding Your Baby | Experimental | Behavioral: Understanding Your BabyUnderstanding Your Baby plus postnatal care as usual |
| Care As Usual | Active comparator | Behavioral: Postnatal care as usualPostnatal care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time mother or father/partner
- Singleton pregnancy
- Mother living together with the baby
- Mother living in the Danish municipalities of Køge, Hvidovre, Høje-Taastrup, Frederiksberg, Lolland, Holbæk, Næstved, Middelfart, Nyborg or Aalborg.
- Understands Danish or English
Key exclusion criteria (1 listed)
- Under the age of 18 when the child is born
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 |
|---|---|---|
| Understanding Your BabyAlso: Forstaa din babyResearch-based knowledge on the understanding and meeting of the baby's socioemotional needs is delivered to the parents systematically by public health visitors based on a manual, cue cards, and video clips at four time points from 1 to 10 months postpartum. | Behavioural | Understanding Your Baby |
| Postnatal care as usualIn accordance with Danish national guidelines, health visitors visit families during the infants first year of life, where they weigh and measure the infant. Further, they offer individual guidance and support regarding for instance feeding, sleeping, how to stimulate the infant, and the developmental stages that the infant goes through. | Behavioural | Care As Usual |
Primary outcome
Maternal Parenting Competence
Time frame: T4 (infant age 11-11.5 months)
Maternal Parenting Competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
6 secondary outcomes
Maternal and Paternal Parenting Competence
Time frame: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)
Maternal and Paternal Parenting Stress
Time frame: T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
Maternal and Paternal Parental Mentalizing
Time frame: T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Maternal and Paternal Mind-Mindedness
Time frame: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Maternal, paternal and child screen use
Time frame: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Infant socio-emotional development
Time frame: T4 (infant age 11-11.5 months)
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 26 May 2026.
- Derived from this study: PubMed 36138482Vaever MS, Krogh MT, Stuart AC, Madsen EB, Haase TW, Egmose I. Understanding Your Baby: protocol for a controlled parallel group study of a universal home-based educational program for first time parents. BMC Psychol. 2022 Sep 22;10(1):223. doi: 10.1186/s40359-022-00924-3.
- Individual participant dataSharing planned: No
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.
Mette S. Væver principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understanding Your Baby and Postnatal care as usual in people with First-time Mothers and Their Partners, run by University of Copenhagen 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 5 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 26 May 2026. 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 Parenting Competence (time frame: T4 (infant age 11-11.5 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 NCT03991416, 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 26 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.