The Rocky Sleep Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00877162
First received: April 3, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Sleep Problems
Behavioral: Controlled crying and routines

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Severity of infant sleep problem on a severity scale (parents' perception) [ Time Frame: 6 & 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Less than an average of twice a night over 5 nights by actigraphy [ Time Frame: 6 & 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: June 2009
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Providing 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.
Behavioral: Controlled crying and routines
Behavioural (teaching and support)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877162

Locations
Canada, British Columbia
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
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00877162     History of Changes
Other Study ID Numbers: H09-00757, CIHR MCT-94836
Study First Received: April 3, 2009
Last Updated: June 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Cognitive and behavioural intervention
trial
group
Behavioral sleep problems

Additional relevant MeSH terms:
Dyssomnias
Sleep Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014