The Playful Learning in Infancy Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Copenhagen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Parental age under the age of 18 when the child is born
Multiple pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Playful Learning in Infancy Program
BehavioralResearch-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
BehavioralIn 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.
Treatment groups
2,327 Participants
are divided into 2 treatment groupsGroup A: Playful Learning in Infancy ProgramExperimental treatment 1 intervention
Group B: Care As UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
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).
Time frame
T3 (infant age 7-7.5 months)2
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).
Time frame
T5 (infant age 11-11.5 months)3
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).
Time frame
T4 (infant age 10-10.5 months)4
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).
Time frame
T5 (infant age 11-11.5 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
LEGO Foundation
Collaborator
Source ClinicalTrials.gov