- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352229
The Playful Learning in Infancy Program (PLIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mette S. Væver, PhD
- Phone Number: +45 35324906
- Email: mette.vaever@psy.ku.dk
Study Contact Backup
- Name: Maja Nyström-Hansen, PhD
- Phone Number: +45 35336499
- Email: mnh@psy.ku.dk
Study Locations
-
-
-
Copenhagen, Denmark, 1353
- Recruiting
- Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
-
Contact:
- Mette S. Væver, PhD
- Phone Number: +45 35324906
- Email: mette.vaever@psy.ku.dk
-
Contact:
- Maja Nyström-Hansen, PhD
- Phone Number: +4535336499
- Email: mnh@psy.ku.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Parental age under the age of 18 when the child is born
- Multiple pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Care As Usual
Postnatal care as usual
|
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.
|
|
Experimental: Playful Learning in Infancy Program
Playful Learning in Infancy Program plus postnatal care as usual
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Stress
Time Frame: T3 (infant age 7-7.5 months)
|
Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).
|
T3 (infant age 7-7.5 months)
|
|
Infant Socio-emotional Development
Time Frame: T5 (infant age 11-11.5 months)
|
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).
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T5 (infant age 11-11.5 months)
|
|
Infant Level of Play
Time Frame: T4 (infant age 10-10.5 months)
|
We have developed questions for the parents to report on the child's level of play, based on Belsky, J., & Most, R. K. (1981).
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T4 (infant age 10-10.5 months)
|
|
Parental Mind-Mindedness
Time Frame: T5 (infant age 11-11.5 months)
|
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).
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T5 (infant age 11-11.5 months)
|
|
Parental Attachment Style
Time Frame: T1/Enrollment (4 weeks - 8 months)
|
Parents' attachment style is assessed using the Experience in Close Relationships-Revised-Short Form (ECR-RS) questionnaire (Fraley et al., 2000).
|
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)
|
Parental mental well-being is assessed using the Warwick-Edinburgh Mental Well-being Scale - (S)WEMWBS (Tennant et al., 2007).
|
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)
|
The infant's screen time is assessed using quantitative questions developed for the project and administered to parents.
|
T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
|
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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)
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Questions developed for the study regarding the parent's involvement in the child's life and daily activities.
|
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)
|
Questions developed for the study for parents in the intervention group regarding knowledge of play.
|
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
|
Qualitative interviews with a subsample of parents.
|
Immediately after the intervention
|
|
Health Visitors' Experience of the PLIP
Time Frame: Immediately after the intervention
|
Qualitative interviews with a subsample of health visitors.
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mette S. Væver, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 514-0335/23-2000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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