Parent-Child Relations Clinical Trial
Official title:
Play2Sleep: A Sequential Explanatory Mixed Methods Study of Using Infant Play to Improve Infant Sleep in Families Experiencing Infant Sleep Disturbance
The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on families of infants with infant sleep disturbances.
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.
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