The Playful Learning in Infancy Program

NCT06352229 | Recruiting

• 1 other identifier: 514-0335/23-2000
• Study Type: interventional
• Target: 2,327
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Infant Development

Keywords

Universal intervention; Playful Learning; Infant; Parental competence; Socioemotional; Public health visitors; Prevention

Outcome Measures

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.

  T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)

Secondary Outcomes (11)

• Parental Stress

  T3 (infant age 7-7.5 months)

• Infant Socio-emotional Development

  T5 (infant age 11-11.5 months)

• Infant Level of Play

  T4 (infant age 10-10.5 months)

• Parental Mind-Mindedness

  T5 (infant age 11-11.5 months)

• Parental Attachment Style

  T1/Enrollment (4 weeks - 8 months)

Study Arms (2)

Playful Learning in Infancy Program

EXPERIMENTAL

Playful Learning in Infancy Program plus postnatal care as usual

Behavioral: Playful Learning in Infancy Program

Care As Usual

ACTIVE COMPARATOR

Postnatal care as usual

Behavioral: Postnatal care as usual

Interventions

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.

Also known as: Leg og samspil, Playful Interactions

Playful Learning in Infancy Program

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.

Care As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parental age under the age of 18 when the child is born
• Multiple pregnancy

Sponsors & Collaborators

• University of Copenhagen: lead
• LEGO Foundation: collaborator

Study Sites (1)

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

Copenhagen, 1353, Denmark

RECRUITING

MeSH Terms

Interventions

Postnatal Care

Intervention Hierarchy (Ancestors)

Perinatal Care; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mette S. Væver

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette S. Væver, PhD

CONTACT

+45 35324906; mette.vaever@psy.ku.dk

Maja Nyström-Hansen, PhD

CONTACT

+45 35336499; mnh@psy.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)