Play2Sleep: Using Play to Improve Infant Sleep

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Disturbances in Initiating and Maintaining Sleep Parent-Child Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Play2Sleep

For the experimental intervention, Play2Sleep consists of video-recording the mother and father separately while engaged in a structured play session. Immediately following the play session, the home visitor will review the video recording with each parent separately to provide positive feedback on parental behaviors that promotes contingent interaction and identification of infant cues. At the end of the visit, standard public health handouts on infant sleep will be provided to both parents.

Group Type EXPERIMENTAL