Clinical trial NCT06352229: The Playful Learning in Infancy Program
Official title: The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Infant Development
Keywords: Universal intervention
Playful Learning
Infant
Parental competence
Socioemotional
Public health visitors
Prevention
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: LEGO Foundation
First posted: 2024-04-08
Enrollment: 2327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Parental Playful interactions
timeFrame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
Secondary outcomes:
measure: Parental Stress
timeFrame: T3 (infant age 7-7.5 months)
measure: Infant Socio-emotional Development
timeFrame: T5 (infant age 11-11.5 months)
measure: Infant Level of Play
timeFrame: T4 (infant age 10-10.5 months)
measure: Parental Mind-Mindedness
timeFrame: T5 (infant age 11-11.5 months)
measure: Parental Attachment Style
timeFrame: T1/Enrollment (4 weeks - 8 months)
measure: Parental Mental Well-Being
timeFrame: T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months)
measure: Infant Screen Time
timeFrame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
measure: Questions developed for the study regarding Parental Involvement
timeFrame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
measure: Questions developed for the study regarding Parental Knowledge of Play
timeFrame: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)
measure: Parental Experience of the PLIP
timeFrame: Immediately after the intervention
measure: Health Visitors' Experience of the PLIP
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Study officials:
affiliation: Department of psychology, University of Copenhagen
name: Mette S. Væver
role: PRINCIPAL_INVESTIGATOR
References: