NCT02742155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

April 5, 2016

Last Update Submit

October 24, 2018

Conditions

Disturbances in Initiating and Maintaining SleepParent-Child Relations

Keywords

Family Research

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Parental report of infant sleep patterns using 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)

    2 months

  • +1 more secondary outcomes

Study Arms (2)

Play2Sleep

EXPERIMENTAL

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

Comparison

ACTIVE COMPARATOR

In the comparison group, only standard public health handouts on infant sleep will be reviewed with parents.

Behavioral: Comparison

Interventions

Play2SleepBEHAVIORAL

Behavioral: Video self-modelling

Play2Sleep
ComparisonBEHAVIORAL

Behavioral: Information only

Comparison

Eligibility Criteria

Age4 Months - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Village Square Community Health Centre

Calgary, Alberta, T1Y 6E7, Canada

Location

East Calgary Health Centre

Calgary, Alberta, T2A 3N4, Canada

Location

Acadia Community Health Centre

Calgary, Alberta, T2H 3A5, Canada

Location

Thornhill Community Health Centre

Calgary, Alberta, T2K 4Y5, Canada

Location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

Sheldon M. Chumir Health Centre

Calgary, Alberta, T2R 0X7, Canada

Location

South Calgary Health Centre

Calgary, Alberta, T2X 3W5, Canada

Location

Shaganappi Community Health Centre

Calgary, Alberta, T3C 0E8, Canada

Location

Northwest Community Health Centre

Calgary, Alberta, T3G 2A7, Canada

Location

Related Publications (2)

  • 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.

    PMID: 34409935DERIVED

  • 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.

    PMID: 29719517DERIVED

Study Officials

  • Karen M Benzies, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 18, 2016

Study Start

December 1, 2016

Primary Completion

July 23, 2018

Study Completion

July 23, 2018

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

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.

Locations

CA(9)