ight waking reduction in Canadian infants: the Rocky Sleep Study

Not Applicable

Completed

Conditions: Behavioural sleep problems
Mental and Behavioural Disorders
Other behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Registration Number: ISRCTN42169337

Lead Sponsor: niversity of British Columbia (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 720

Inclusion Criteria

Infants:
1. Have no identified health problems
2. Between corrected ages of 5.5 and 8 months, either sex
3. Meet the American Academy of Sleep Medicine (AASM) sleep problem criteria (waking two or more times per night and/or waking lasting more than 20 minutes, occurring at least four nights per week for a minimum of three weeks)

Parents:
1. Biological or adoptive
2. Can read and speak English
3. Have access to a telephone
4. Are in single parent families or two parent families with both parents committing to the study

Exclusion Criteria

Infants:
1. Organic causes of sleep disruption
2. Developmental disability
3. Chronic neurological or respiratory conditions

Parents:
1. Diagnosed depression
2. Diagnosed sleep problems
3. Permanent night shift work

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant infant sleep disturbance as measured with a composite measure, consisting of either the parent reporting a severe sleep problem, using the four-point sleep problem severity measure (no problem to severe problem), or mean actigraphic wakes of greater than two per night averaged over five nights at six weeks post-teaching session. These measures will be obtained at baseline, 6 weeks post-teaching session and 24 weeks post-teaching session.

Secondary Outcome Measures

Name	Time	Method
Measured at 6 and 24 weeks post-teaching session:<br>1. Infants' averaged mean wakes over five nights by actigraphy<br>2. Parents' perceptions of sleep problems (using the four-point sleep problem severity measure)<br>3. Fatigue (using the Multidimensional Assessment of Fatigue Scale)<br>4. Depressed mood (using the Centre for Epidemiologic Studies Depression Measure)<br>5. Duration of infants' longest sleep periods (by actigraphy)<br>6. Parents? quality of sleep (using the Pittsburgh Sleep Quality Index)<br>7. Quality of parental cognitions about infant sleep (using the Maternal Cognitions about Infant Sleep Questionnaire)<br>8. Costs for the intervention compared to the costs of parents using other sources of help (using resources consumed and unit prices for resources, including intervention costs)