Clinical trial NCT02742155: Play2Sleep: Using Play to Improve Infant Sleep
Official title: Play2Sleep: A Sequential Explanatory Mixed Methods Study of Using Infant Play to Improve Infant Sleep in Families Experiencing Infant Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disturbances in Initiating and Maintaining Sleep
Parent-Child Relations
Keywords: Family Research
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 136
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant night wakings using the Brief Infant Sleep Questionnaire
timeFrame: 2 months
Secondary outcomes:
measure: Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire
timeFrame: 2 months
measure: Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 2 months
measure: Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale
timeFrame: 2 months
measure: Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)
timeFrame: 2 months
measure: Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)
timeFrame: 2 months
measure: Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)
timeFrame: 2 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Village Square Community Health Centre
state: Alberta
city: Calgary
country: Canada
facility: East Calgary Health Centre
state: Alberta
city: Calgary
country: Canada
facility: Acadia Community Health Centre
state: Alberta
city: Calgary
country: Canada
facility: Thornhill Community Health Centre
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Sheldon M. Chumir Health Centre
state: Alberta
city: Calgary
country: Canada
facility: South Calgary Health Centre
state: Alberta
city: Calgary
country: Canada
facility: Shaganappi Community Health Centre
state: Alberta
city: Calgary
country: Canada
facility: Northwest Community Health Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Karen M Benzies, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.