The Playful Learning in Infancy Program

Parent-Child Relations Clinical Trial

— PLIP  

Official title:

The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352229
• Other study ID #: 514-0335/23-2000
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: University of Copenhagen
• Contact: Mette S. Væver, PhD
• Phone: +45 35324906
• Email: mette.vaever[@]psy.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2327
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• Parent-Child Relations

Intervention

Behavioral:
• Playful Learning in Infancy Program
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 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.

Locations

Country	Name	City	State
Denmark	Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	LEGO Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Secondary	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).	T3 (infant age 7-7.5 months)
Secondary	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).	T5 (infant age 11-11.5 months)
Secondary	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).	T4 (infant age 10-10.5 months)
Secondary	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).	T5 (infant age 11-11.5 months)
Secondary	Parental Attachment Style	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)
Secondary	Parental Mental Well-Being	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)
Secondary	Infant Screen Time	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)
Secondary	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.	T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Secondary	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.	T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Secondary	Parental Experience of the PLIP	Qualitative interviews with a subsample of parents.	Immediately after the intervention
Secondary	Health Visitors' Experience of the PLIP	Qualitative interviews with a subsample of health visitors.	Immediately after the intervention