Sleep Problems Clinical Trial
Official title:
Night Waking Reduction in Canadian Infants: A Randomized Controlled Clinical Trial of a Parent-based Cognitive and Behavioural Intervention in Community Health Units.
Verified date | June 2012 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Night waking with crying can be a distressing and difficult experience for infants and their parents. The investigators want to reduce infant night waking and crying and improve parents' views of their infants' sleep. This study will help the investigators determine whether parents who receive group teaching about infant sleep and follow-up phone calls provided by Public Health Nurses will reduce numbers of infants' night wakes and parents' perceptions of infant sleep difficulties compared with parents who receive a group teaching about infant safety and follow-up phone calls provided by Public Health Nurses. Results from this study will help the investigators improve their practice when assisting parents and infants with sleep problems.
Status | Completed |
Enrollment | 235 |
Est. completion date | September 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 8 Months |
Eligibility |
Inclusion Criteria: - Parents and their healthy 5.5 to 8 month-old infants. - Infants are waking 2 or more times per night or more than 20 minutes for at least 4 nights per week for a minimum of 3 weeks. - Parents are biological or have adopted their infants, can speak and read English, have access to a telephone and are in two or one parent families. Exclusion Criteria: - Infants are excluded who have biological causes of sleep problems, developmental disability, and/or chronic neurological or respiratory conditions. - Parents are excluded who have diagnosed depression and are receiving treatment, have diagnosed sleep problems (e.g. sleep apnea), and are working permanent night shifts. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Richmond Community Health Services | Richmond | British Columbia |
Canada | North Shore Coastal Community Health | Vancouver | British Columbia |
Canada | Pacific Spirit Community Health Centre | Vancouver | British Columbia |
Canada | South Community Health Office | Vancouver | British Columbia |
Canada | Three Bridges Community Health Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of infant sleep problem on a severity scale (parents' perception) | 6 & 24 weeks | No | |
Secondary | Less than an average of twice a night over 5 nights by actigraphy | 6 & 24 weeks | No |
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