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Recruiting NCT06352229

The Playful Learning in Infancy Program

No phase Interventional Parent-Child Relations Infant Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Playful Learning in Infancy Program, Postnatal care as usual.
Who it may be relevant to
Registry conditions: Parent-Child Relations, Infant Development. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • Behavioral 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (11)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Center for Early Interventions and Family Studies, Department of Psychology, University of — Copenhagen

Identifiers

NCT: NCT06352229 · 514-0335/23-2000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗