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|Status||Condition||Sponsor/Collaborator(s)||First Received||Last Changed||Verification Date|
|Completed||Sleep Problems||University of British Columbia
collaborator(s): Canadian Institutes of Health Research (CIHR)
|April 3, 2009||June 18, 2012||June 2012|
|Study Type||Study Design||Phase||Enrollment||Start Date||End Date|
|Interventional||Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment||N/A||235||June 2009||-|
|Richmond Community Health Services||Richmond British Columbia Canada||-||-||-||-|
|Pacific Spirit Community Health Centre||Vancouver British Columbia Canada||-||-||-||-|
|Three Bridges Community Health Centre||Vancouver British Columbia Canada||-||-||-||-|
|South Community Health Office||Vancouver British Columbia Canada||-||-||-||-|
|North Shore Coastal Community Health||Vancouver British Columbia Canada||-||-||-||-|
|Behavioral||Controlled crying and routines||Behavioural (teaching and support)|
|Type||Measure||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|
Night Waking Reduction in Canadian Infants: A Randomized Controlled Clinical Trial of a Parent-based Cognitive and Behavioural Intervention in Community Health Units.
Background: Infant behavioural sleep problems affect up to 50% of infants, can persist, and
can contribute to adverse developmental outcomes. Persistent short night sleep periods from
5-to 29 months of age have been associated with more hyperactivity and inattention, and
lower abilities at cognitive tasks for older children. Sleep problems in infants are also
associated with parental stress, fatigue and family tension, and maternal depression. Health
care professionals often fail to recognize and treat infant sleep problems and over 40 books
and many websites provide conflicting advice. Interventions directed at changing parents'
cognitions and behaviours have reduced infant night waking and reduced parents' distress;
however, inexpensive, short term group interventions to improve infant sleep problems and
reduce effects of conflicting advice are needed. Parents' knowledge about infant sleep
affects their behaviours at bedtime and responses to night waking. Combined
cognitive-behavioural approaches can modify those factors and improve outcomes.
Research Design: The study is a randomized controlled trial aimed at 6 to 8-month-old
infants who are waking at night and crying, with stratification by community health centres
and blinded analysis of actigraphic/sleep diary data Primary Question: In a population of
parents who have infants with behavioural sleep problems are parents randomized to a
cognitive-behavioural sleep intervention compared to parents randomized to a group
cognitive-behavioural safety intervention more or less likely to: a) identify their child as
having a severe sleep problem, or b) to have their child wake fewer than an average of 2
times per night over 5 nights by actigraphy? Inclusion criteria: Biological or adoptive
parents who: 1) read and speak English, 2) have access to a telephone, and 3) are in two
parent or single parent families. Infants who are: 1) healthy, 2) between 5.5 and 8 months
of age, and 3) screened and identified as having a sleep problem.
Exclusion criteria: Infants with: 1) organic causes of sleep disruption, 2) developmental
disability, and 3) chronic neurological or respiratory conditions. Parents with 1) diagnosed
depression, 2) diagnosed sleep problems, and 3) permanent night shift work.
Sample size: The team will randomize 240 families with infants to the control or
The Intervention: We will recruit families through programs at community 5 health centres,
the Vancouver Coastal Health Website, and the Newborn Hotline. Prior to randomization,
experimental and control groups will be screened for infant sleep problems and provide
baseline data by questionnaire (sleep cognitions, depression, sleep quality, and fatigue),
infant sleep diaries and actigraphy. The intervention has high ecological validity, because
public health nurses will offer a group format with 1 teaching session and four phone calls
in a community setting. The experimental group and control group will receive a short 2 hour
teaching session to change cognitions and behaviour to manage infant sleep problems and
infant safety respectively. For the experimental group, cognitions include thoughts about
normal infant sleep and developmental appropriateness of infant self-soothing. Both groups
will receive two weeks of telephone support twice weekly.
Primary Outcome: A significant infant sleep disturbance as measured with a composite
measure, which will consist of either parent reporting a severe sleep problem OR mean
actigraphic wakes of greater than 2 per night averaged over 5 nights at 6 weeks
post-teaching session. The control group will receive a sleep pamphlet after 6 weeks and
experimental group will receive a safety pamphlet.
Analysis: All analysis will follow the intent-to-treat principle. We will apply Fisher's
exact test to compare outcome prevalence of our primary composite of severe problems or
wakes averaging more than 2 per night over 5 nights between groups. We will assess
variation between health units using logistic regression, incorporating terms for health
unit and health unit by treatment interaction.
Significance: The trial will be complete in 30 months and has the potential to build
capacity in community health nurses to offer systematic programs to manage infant sleep
|Gender||Minimum Age||Maximum Age||Healthy Volunteers|
|Both||-||8 Months||Accepts Healthy Volunteers|
- 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.
- 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.