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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02742155
Enrollment
136
Registered
2016-04-18
Start date
2016-12-31
Completion date
2018-07-23
Last updated
2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disturbances in Initiating and Maintaining Sleep, Parent-Child Relations

Keywords

Family Research

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.

Interventions

BEHAVIORALComparison

Behavioral: Information only

BEHAVIORALPlay2Sleep

Behavioral: Video self-modelling

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Months to 5 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant night wakings using the Brief Infant Sleep Questionnaire2 monthsAs provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire

Secondary

MeasureTime frameDescription
Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)2 months
Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale2 months
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire2 monthsAs provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire.
Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)2 monthsThe 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).
Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)2 months
Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)2 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026