Play2Sleep: Using Play to Improve Infant Sleep
Condition: Disturbances in Initiating and Maintaining Sleep; Parent-Child Relations
Study type: Interventional

Summary: 
      The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on
      families of infants with infant sleep disturbances.
    

Detailed description: 
      RESEARCH OBJECTIVE AND QUESTIONS:

      The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on
      families of infants with infant sleep disturbances.

      The quantitative research question is: Does one dose of Play2Sleep delivered during home
      visits with mothers and fathers of 5-month-old infants with infant sleep disturbances reduce
      the number of night wakings at age 7 months? The qualitative phase will focus on explaining
      the quantitative findings by asking: What are parental perceptions of family experiences,
      processes, and contexts related to Play2Sleep and infant sleep? The overarching mixed methods
      research question is: How do parental perceptions of family experiences, processes, and
      contexts related to infant sleep explain the effectiveness of Play2Sleep?

      METHODS:

      An explanatory sequential mixed methods design will be used. The quantitative phase will be a
      pilot randomized controlled trial and the subsequent qualitative phase will employ Thematic
      Analysis of parental interviews to understand their perspectives on the effectiveness and
      acceptability of Play2Sleep.

      Public health nurses will introduce potential participants to the study during 4-month
      well-baby clinic visits. Inclusion criteria will be English-speaking mothers and fathers of
      healthy infants who perceive that their child has sleep problems. A total of 60
      mother-father-infant triads with complete data will be obtained: 30 intervention; 30
      comparison.

      The experimental intervention, Play2Sleep, will occur during a home visit when the infant is
      5 months old and will consist of video-recording each parent engaging in a structured play
      session with their infant. Immediately following the interaction sequence, the
      video-recording will be reviewed with the parent. Positive feedback on parental behaviors
      that promote interaction and child development will be provided during the video review. This
      will include the identification of the infant's social and sleep related cues. In addition to
      the standard public health handout on infant sleep, a handout on parent-infant behaviours
      will be given to encourage one or two areas that parents can continue to develop. During the
      video-recording and review, the other parent will not be present. The structured play
      sequence will follow established protocols in the Parent-Child Interaction Teaching Scale
      manual. The comparison group will receive only the standard public health handout.

      Based on maximum and minimum changes in infant sleep, 20 families (10 intervention families
      and 10 comparison families) will be invited to participate in evaluative qualitative
      interviews upon completing the second home visit. Semi-structured family interviews will
      elicit descriptions about parental experiences that explain the quantitative findings.
      Interview will be transcribed and transcripts will be analyzed using Thematic Analysis.
      Preliminary results of the thematic analysis will be submitted to the qualitative
      participants for review and opportunities for clarification or further explication will be
      provided.

      The quantitative and qualitative results will then be integrated together to draw overarching
      conclusions about the effectiveness of Play2Sleep. Specifically, the results from the
      qualitative interviews will be used to explain and contextualize the quantitative results.
    

Intervention name(s): Play2Sleep; Comparison
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral: Video self-modelling; Behavioral: Information only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Family Research