Play2Sleep: Using Play to Improve Infant Sleep

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.

Study Overview

• Status: Completed
• Conditions: Parent-Child Relations; Disturbances in Initiating and Maintaining Sleep
• Intervention / Treatment: Behavioral: Play2Sleep; Behavioral: Comparison

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N1
      • University of Calgary
    • Calgary, Alberta, Canada, T2X 3W5
      • South Calgary Health Centre
    • Calgary, Alberta, Canada, T2R 0X7
      • Sheldon M. Chumir Health Centre
    • Calgary, Alberta, Canada, T1Y 6E7
      • Village Square Community Health Centre
    • Calgary, Alberta, Canada, T2A 3N4
      • East Calgary Health Centre
    • Calgary, Alberta, Canada, T2H 3A5
      • Acadia Community Health Centre
    • Calgary, Alberta, Canada, T2K 4Y5
      • Thornhill Community Health Centre
    • Calgary, Alberta, Canada, T3C 0E8
      • Shaganappi Community Health Centre
    • Calgary, Alberta, Canada, T3G 2A7
      • Northwest Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 5 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Play2Sleep; Behavioral: Video self-modelling
Active Comparator: Comparison; In the comparison group, only standard public health handouts on infant sleep will be reviewed with parents.	Behavioral: Comparison; Behavioral: Information only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant night wakings using the Brief Infant Sleep Questionnaire	As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire	As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire.	2 months
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
Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)	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).	2 months
Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)		2 months

Collaborators and Investigators

• Sponsor: University of Calgary

Publications and helpful links

General Publications

• Keys EM, Benzies KM, Kirk VG, Duffett-Leger L. Effect of Play2Sleep on mother-reported and father-reported infant sleep: a sequential explanatory mixed-methods study of a randomized controlled trial. J Clin Sleep Med. 2022 Feb 1;18(2):439-452. doi: 10.5664/jcsm.9618.
• Keys E, Benzies KM, Kirk V, Duffett-Leger L. Using Play to Improve Infant Sleep: A Mixed Methods Protocol to Evaluate the Effectiveness of the Play2Sleep Intervention. Front Psychiatry. 2018 Apr 17;9:109. doi: 10.3389/fpsyt.2018.00109. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 23, 2018
• Study Completion (Actual): July 23, 2018

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Family Research
• Other Study ID Numbers: REB15-2652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following study completion, de-identified data will be submitted to SAGE at Policy Wise (formerly the Child Data Centre of Alberta), a research and data facility operating under the authority of the Alberta Centre for Child, Family and Community Research.