Play2Sleep: Using Play to Improve Infant Sleep

Not Applicable

Completed

• Conditions: Disturbances in Initiating and Maintaining Sleep; Parent-Child Relations
• Interventions: Behavioral: Play2Sleep; Behavioral: Comparison

• Registration Number: NCT02742155
• Lead Sponsor: University of Calgary

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Study Start: 2016-12
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• co-habiting mothers and fathers of full-term, healthy, singleton, 4-month old infants
• first-time parents
• able to read, write, and speak English
• perceive that their infant has sleep disturbances
• whose infant experiences one of the following: (a) greater than 3 night wakings per night; (b) awake greater than 60 minutes during the night; or (c) less than 9 hours total day and night time sleep.

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Exclusion Criteria

• a known or suspected medical or physiological cause of sleep problems in either parent or infant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Play2Sleep	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.
Comparison	Comparison	In the comparison group, only standard public health handouts on infant sleep will be reviewed with parents.

Primary Outcome Measures

Name	Time	Method
Infant night wakings using the Brief Infant Sleep Questionnaire	2 months	As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire

Secondary Outcome Measures

Name	Time	Method
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire	2 months	As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire.
Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)	2 months
Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale	2 months
Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)	2 months
Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)	2 months
Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)	2 months	The PCITS is a 73-item coding scheme of a structured parent-child play session that measure the quality of parent-child interactions. Play sessions follow established protocols in the Parent-child interaction teaching scale manual and are video recorded for later coded according to the PCITS items. The PCITS includes 4 parent sub-scales (sensitivity, response to child's distress, social-emotional growth fostering, and cognitive growth fostering) and 2 child sub-scales (clarity of cues and responsiveness to caregiver).

Trial Locations

Locations (9)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Shaganappi Community Health Centre; 🇨🇦 Calgary, Alberta, Canada

Thornhill Community Health Centre; 🇨🇦 Calgary, Alberta, Canada

South Calgary Health Centre; 🇨🇦 Calgary, Alberta, Canada

Northwest Community Health Centre; 🇨🇦 Calgary, Alberta, Canada

Acadia Community Health Centre; 🇨🇦 Calgary, Alberta, Canada

Village Square Community Health Centre; 🇨🇦 Calgary, Alberta, Canada

East Calgary Health Centre; 🇨🇦 Calgary, Alberta, Canada

Sheldon M. Chumir Health Centre; 🇨🇦 Calgary, Alberta, Canada