Parent-Child Relations Clinical Trial
Official title:
Play2Sleep: A Sequential Explanatory Mixed Methods Study of Using Infant Play to Improve Infant Sleep in Families Experiencing Infant Sleep Disturbance
NCT number | NCT02742155 |
Other study ID # | REB15-2652 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | July 23, 2018 |
Verified date | October 2018 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate and explore the effectiveness of Play2Sleep on families of infants with infant sleep disturbances.
Status | Completed |
Enrollment | 136 |
Est. completion date | July 23, 2018 |
Est. primary completion date | July 23, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Months to 5 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Acadia Community Health Centre | Calgary | Alberta |
Canada | East Calgary Health Centre | Calgary | Alberta |
Canada | Northwest Community Health Centre | Calgary | Alberta |
Canada | Shaganappi Community Health Centre | Calgary | Alberta |
Canada | Sheldon M. Chumir Health Centre | Calgary | Alberta |
Canada | South Calgary Health Centre | Calgary | Alberta |
Canada | Thornhill Community Health Centre | Calgary | Alberta |
Canada | University of Calgary | Calgary | Alberta |
Canada | Village Square Community Health Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Parental depression using the Edinburgh Postnatal Depression Scale (EPDS) | 2 months | ||
Secondary | Parental Sense of Competence using the Parental Sense of Competence (PSOC) Scale | 2 months | ||
Secondary | Marital satisfaction using the brief version of the Dyadic Adjustment Scale (DAS-4) | 2 months | ||
Secondary | 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 | |
Secondary | Parental cognitions about infant sleep using the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ) | 2 months |
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