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NCT Number: NCT06352229

The Playful Learning in Infancy Program

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.

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Key information

Conditions

Parent-Child Relations Infant Development

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen

Copenhagen, 1353, Denmark

Location status: Recruiting

Location contact

Maja Nyström-Hansen, PhD

CONTACT

[email protected]

+4535336499

Mette S. Væver, PhD

CONTACT

[email protected]

+45 35324906

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Playful Learning in Infancy Program

Behavioral

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.

Other names: Leg og samspil, Playful Interactions

Postnatal care as usual

Behavioral

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 outcomes

  1. 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

  1. Parental Stress

    Time frame: T3 (infant age 7-7.5 months)

    Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).

  2. Infant Socio-emotional Development

    Time frame: T5 (infant age 11-11.5 months)

    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).

  3. Infant Level of Play

    Time frame: T4 (infant age 10-10.5 months)

    We have developed questions for the parents to report on the child's level of play, based on Belsky, J., & Most, R. K. (1981).

  4. Parental Mind-Mindedness

    Time frame: T5 (infant age 11-11.5 months)

    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).

  5. Parental Attachment Style

    Time frame: T1/Enrollment (4 weeks - 8 months)

    Parents' attachment style is assessed using the Experience in Close Relationships-Revised-Short Form (ECR-RS) questionnaire (Fraley et al., 2000).

  6. Parental Mental Well-Being

    Time frame: T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months)

    Parental mental well-being is assessed using the Warwick-Edinburgh Mental Well-being Scale - (S)WEMWBS (Tennant et al., 2007).

  7. 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)

    The infant's screen time is assessed using quantitative questions developed for the project and administered to parents.

  8. 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 the parent's involvement in the child's life and daily activities.

  9. 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)

    Questions developed for the study for parents in the intervention group regarding knowledge of play.

  10. Parental Experience of the PLIP

    Time frame: Immediately after the intervention

    Qualitative interviews with a subsample of parents.

  11. Health Visitors' Experience of the PLIP

    Time frame: Immediately after the intervention

    Qualitative interviews with a subsample of health visitors.

Study contacts

Contact information is provided by the study sponsor or research team.

Maja Nyström-Hansen, PhD

CONTACT

[email protected]

+45 35336499

Mette S. Væver, PhD

CONTACT

[email protected]

+45 35324906

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • LEGO Foundation

Registry information

Official study title

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

Acronym: PLIP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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