Parent-Child RelationsPLIPNCT06352229
The Playful Learning in Infancy Program
A study testing Playful Learning in Infancy Program and Postnatal care as usual in people with Parent-Child Relations and Infant Development, run by University of Copenhagen at 1 site in Denmark.
Trial summary
In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent-Child Relations, Infant Development
- What is being tested?
- Playful Learning in Infancy Program 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
- 2,327 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Residence address in the Danish municipalities of Hvidovre or Billund
- Residence address with child or legal custody of the child
- Child is between 1-7 months old
- Understands Danish or English
Who cannot join
- Parental age under the age of 18 when the child is born
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Copenhagen, 1353
Mette S. Væver, PhD, +45 35324906, mette.vaever@psy.ku.dk
Maja Nyström-Hansen, PhD, +4535336499, mnh@psy.ku.dk
About this study
Official title: The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design
In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.
The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.
Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.
- Conditions
- Parent-Child Relations, Infant Development
- Being tested
- Playful Learning in Infancy Program, Postnatal care as usual
- Keywords
- Universal intervention, Playful Learning, Infant, Parental competence, Socioemotional, Public health visitors, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playful Learning in Infancy ProgramBehavioural
Also called Leg og samspil, Playful Interactions
Research-based knowledge on play with babies delivered to the parents systematically by public health visitors based on a manual, activity cards, and video clips at four time points from 0 to 12 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 |
|---|---|---|
| Playful Learning in Infancy Program | Experimental | Playful Learning in Infancy Program plus postnatal care as usual Receives: Behavioral: Playful Learning in Infancy Program |
| 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.
Parental Playful interactions
Playful interactions are assessed using The Parent Play Questionnaire (PPQ) by Ahmadzadeh et al. (2020), which assesses the frequency of parent-child play and screen use.
Measured: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Secondary outcomes (11)
Parental 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: T3 (infant age 7-7.5 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: T5 (infant age 11-11.5 months)
Infant Level of Play
We have developed questions for the parents to report on the child's level of play, based on Belsky, J., \& Most, R. K. (1981).
Measured: T4 (infant age 10-10.5 months)
Parental Mind-Mindedness
Parental mind-mindedness is assessed using a written response to the first question from the "Describe your 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: T5 (infant age 11-11.5 months)
Parental Attachment Style
Parents' attachment style is assessed using the Experience in Close Relationships-Revised-Short Form (ECR-RS) questionnaire (Fraley et al., 2000).
Measured: T1/Enrollment (4 weeks - 8 months)
Parental Mental Well-Being
Parental mental well-being is assessed using the Warwick-Edinburgh Mental Well-being Scale - (S)WEMWBS (Tennant et al., 2007).
Measured: T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months)
Infant Screen Time
The infant's screen time is assessed using quantitative questions developed for the project and administered to parents.
Measured: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Questions developed for the study regarding Parental Involvement
Questions developed for the study regarding the parent's involvement in the child's life and daily activities.
Measured: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Questions developed for the study regarding Parental Knowledge of Play
Questions developed for the study for parents in the intervention group regarding knowledge of play.
Measured: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Parental Experience of the PLIP
Qualitative interviews with a subsample of parents.
Measured: Immediately after the intervention
Health Visitors' Experience of the PLIP
Qualitative interviews with a subsample of health visitors.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies 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
- Model description
- 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 along with the Playful Learning in Infancy Program.
- Masking
- None (open label)
- Enrolment
- 2,327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- LEGO Foundation
- 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
- NCT06352229
- Sponsor's protocol ID
- 514-0335/23-2000
- Acronym
- PLIP
- Status last verified
- May 2026
- First submitted
- 20 Mar 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design
- ClinicalTrials.gov ID
- NCT06352229
- Acronym / sponsor ID
- PLIP / 514-0335/23-2000
- Conditions
- Parent-Child Relations, Infant Development
- Keywords
- Universal intervention, Playful Learning, Infant, Parental competence, Socioemotional, Public health visitors, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,327 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- LEGO Foundation
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Apr 2024 (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 the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.
The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.
Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 along with the Playful Learning in Infancy Program.
| Arm | Type | Receives |
|---|---|---|
| Playful Learning in Infancy Program | Experimental | Behavioral: Playful Learning in Infancy ProgramPlayful Learning in Infancy Program 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 (4 listed)
- Residence address in the Danish municipalities of Hvidovre or Billund
- Residence address with child or legal custody of the child
- Child is between 1-7 months old
- Understands Danish or English
Key exclusion criteria (2 listed)
- Parental age under the age of 18 when the child is born
- Multiple pregnancy
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 |
|---|---|---|
| Playful Learning in Infancy ProgramAlso: Leg og samspil, Playful InteractionsResearch-based knowledge on play with babies delivered to the parents systematically by public health visitors based on a manual, activity cards, and video clips at four time points from 0 to 12 months postpartum. | Behavioural | Playful Learning in Infancy Program |
| 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
Parental Playful interactions
Time frame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Playful interactions are assessed using The Parent Play Questionnaire (PPQ) by Ahmadzadeh et al. (2020), which assesses the frequency of parent-child play and screen use.
11 secondary outcomes
Parental Stress
Time frame: T3 (infant age 7-7.5 months)
Infant Socio-emotional Development
Time frame: T5 (infant age 11-11.5 months)
Infant Level of Play
Time frame: T4 (infant age 10-10.5 months)
Parental Mind-Mindedness
Time frame: T5 (infant age 11-11.5 months)
Parental Attachment Style
Time frame: T1/Enrollment (4 weeks - 8 months)
Parental Mental Well-Being
Time frame: T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months)
Infant Screen Time
Time frame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Questions developed for the study regarding Parental Involvement
Time frame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Questions developed for the study regarding Parental Knowledge of Play
Time frame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Parental Experience of the PLIP
Time frame: Immediately after the intervention
Health Visitors' Experience of the PLIP
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Playful Learning in Infancy Program and Postnatal care as usual in people with Parent-Child Relations and Infant Development, 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 4 inclusion and 2 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette S. Væver, PhD (+45 35324906, mette.vaever@psy.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Playful interactions (time frame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.