Disturbances in Initiating and Maintaining SleepNCT02742155
Play2Sleep: Using Play to Improve Infant Sleep
A study testing Play2Sleep and Comparison in people with Disturbances in Initiating and Maintaining Sleep and Parent-Child Relations, run by University of Calgary at 9 sites in Canada.
Trial summary
The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on families of infants with infant sleep disturbances. Read more about this study
- Who is it for?
- Ages 4 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Disturbances in Initiating and Maintaining Sleep, Parent-Child Relations
- What is being tested?
- Play2Sleep and Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 9 sitesCanada
- Study dates
- Dec 2016to 23 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- a known or suspected medical or physiological cause of sleep problems in either parent or infant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Village Square Community Health Centre
Calgary, Alberta, T1Y 6E7
East Calgary Health Centre
Calgary, Alberta, T2A 3N4
Acadia Community Health Centre
Calgary, Alberta, T2H 3A5
Thornhill Community Health Centre
Calgary, Alberta, T2K 4Y5
University of Calgary
Calgary, Alberta, T2N4N1
Sheldon M. Chumir Health Centre
Calgary, Alberta, T2R 0X7
South Calgary Health Centre
Calgary, Alberta, T2X 3W5
Shaganappi Community Health Centre
Calgary, Alberta, T3C 0E8
Northwest Community Health Centre
Calgary, Alberta, T3G 2A7
About this study
Official title: 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.
Read the 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.
- Being tested
- Play2Sleep, Comparison
- Keywords
- Family Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play2SleepBehavioural
Behavioral: Video self-modelling
ComparisonBehavioural
Behavioral: Information only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Play2Sleep |
| Comparison | Active comparator | In the comparison group, only standard public health handouts on infant sleep will be reviewed with parents. Receives: Behavioral: Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant night wakings using the Brief Infant Sleep Questionnaire
As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire
Measured: 2 months
Secondary outcomes (6)
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.
Measured: 2 months
Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)
Measured: 2 months
Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale
Measured: 2 months
Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)
Measured: 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).
Measured: 2 months
Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startDec 2016
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disturbances in Initiating and Maintaining SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Benzies, University of Calgary
- Investigators
- Karen M Benzies, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742155
- Sponsor's protocol ID
- REB15-2652
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2016
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34409935Keys 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.
PubMed 29719517
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Play2Sleep: A Sequential Explanatory Mixed Methods Study of Using Infant Play to Improve Infant Sleep in Families Experiencing Infant Sleep Disturbance
- ClinicalTrials.gov ID
- NCT02742155
- Acronym / sponsor ID
- REB15-2652
- Keywords
- Family Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Play2Sleep | Experimental | Behavioral: Play2SleepFor 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 | Active comparator | Behavioral: ComparisonIn the comparison group, only standard public health handouts on infant sleep will be reviewed with parents. |
Who may qualify
- Ages
- 4 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- a known or suspected medical or physiological cause of sleep problems in either parent or infant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play2SleepBehavioral: Video self-modelling | Behavioural | Play2Sleep |
| ComparisonBehavioral: Information only | Behavioural | Comparison |
Primary outcome
Infant night wakings using the Brief Infant Sleep Questionnaire
Time frame: 2 months
As provided by parental report using the Expanded version of the Brief Infant Sleep Questionnaire
6 secondary outcomes
Parental report of infant sleep patterns using the Brief Infant Sleep Questionnaire
Time frame: 2 months
Parental depression using the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 2 months
Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale
Time frame: 2 months
Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4)
Time frame: 2 months
Parent-child interactions using the Parent-Child Interaction Teaching Scale (PCITS)
Time frame: 2 months
Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 34409935Keys 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.
- Derived from this study: PubMed 29719517Keys 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Benzies, PhD principal investigator
University of Calgary
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play2Sleep and Comparison in people with Disturbances in Initiating and Maintaining Sleep and Parent-Child Relations, run by University of Calgary at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant night wakings using the Brief Infant Sleep Questionnaire (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.