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Clinical Trials/NCT06352229
NCT06352229
Recruiting
N/A

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

University of Copenhagen1 site in 1 country2,327 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parent-Child Relations
Sponsor
University of Copenhagen
Enrollment
2327
Locations
1
Primary Endpoint
Parental Playful interactions
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
November 30, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mette Væver

PhD, Professor

University of Copenhagen

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Infant Socio-emotional Development(T5 (infant age 11-11.5 months))
  • Parental Attachment Style(T1/Enrollment (4 weeks - 8 months))
  • Infant Screen Time(T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months))
  • Infant Level of Play(T4 (infant age 10-10.5 months))
  • Questions developed for the study regarding Parental 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 Mind-Mindedness(T5 (infant age 11-11.5 months))
  • Parental Experience of the PLIP(Immediately after the intervention)
  • Parental Stress(T3 (infant age 7-7.5 months))
  • Parental Mental Well-Being(T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months))
  • Health Visitors' Experience of the PLIP(Immediately after the intervention)
  • Questions developed for the study regarding Parental Involvement(T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months))

Study Sites (1)

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