The Rocky Sleep Study
Night Waking Reduction in Canadian Infants: A Randomized Controlled Clinical Trial of a Parent-based Cognitive and Behavioural Intervention in Community Health Units.
2 other identifiers
interventional
235
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 20, 2012
June 1, 2012
1.9 years
April 3, 2009
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of infant sleep problem on a severity scale (parents' perception)
6 & 24 weeks
Secondary Outcomes (1)
Less than an average of twice a night over 5 nights by actigraphy
6 & 24 weeks
Study Arms (1)
1
EXPERIMENTALProviding parents with a group teaching intervention (2 hours long). The teaching session is followed by 2 weeks of phone calls twice a week to offer parents support for their use of the strategies described in the teaching session and to clarify any questions about the teaching session content. The arm will have baseline data collected one week prior to the teaching session. Follow-up data will be collected at 6 and 24 weeks post intervention. A pamphlet on infant safety will be distributed to the intervention arm following the 6 week data collection point. A pamphlet on managing behavioural sleep problems will distributed to the control group following the 6 week data collection point.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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, Canada
Related Publications (1)
Hall WA, Hutton E, Brant RF, Collet JP, Gregg K, Saunders R, Ipsiroglu O, Gafni A, Triolet K, Tse L, Bhagat R, Wooldridge J. A randomized controlled trial of an intervention for infants' behavioral sleep problems. BMC Pediatr. 2015 Nov 13;15:181. doi: 10.1186/s12887-015-0492-7.
PMID: 26567090DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Hall, RN, PhD
University of British Columbia
- STUDY DIRECTOR
Radhika Bhagat, RN, MN
Vancouver Coastal Health
- STUDY DIRECTOR
Rollin Brant, Ph.D
Centre for Community Child Health Research
- STUDY DIRECTOR
Jean Paul Collett, Ph.D
Child and Family Research Institute
- STUDY DIRECTOR
Amiram Gafni, Ph.D
McMaster University
- STUDY DIRECTOR
Dorothy Hamilton, RN, BSN
Vancouver Coastal Health
- STUDY DIRECTOR
Eileen Hutton, Ph.D
McMaster University
- STUDY DIRECTOR
Kathy Hydamaka, RN, BSN
Vancouver Coastal Health
- STUDY DIRECTOR
Osman Ipsiroglu, MD
Sunny Hill Health Centre for Children
- STUDY DIRECTOR
Valerie Munroe, RN, MSN
Vancouver Coastal Health Research Institute
- STUDY DIRECTOR
Roy Saunders, MD
Seymour Medical Clinic
- STUDY DIRECTOR
Kathy Triolet, RN, BSN
Vancouver Coastal Health
- STUDY DIRECTOR
Lillian Tse, RN, MSN
Vancouver Coastal Health
- STUDY DIRECTOR
Joanne Wooldridge, RN, MSN
Vancouver Coastal Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 7, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2011
Study Completion
September 1, 2011
Last Updated
June 20, 2012
Record last verified: 2012-06