Sleep ProblemsNCT00877162
The Rocky Sleep Study
A study of Sleep Problems, run by University of British Columbia at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Richmond Community Health Services
Richmond, British Columbia
North Shore Coastal Community Health
Vancouver, British Columbia
Pacific Spirit Community Health Centre
Vancouver, British Columbia
South Community Health Office
Vancouver, British Columbia
Three Bridges Community Health Centre
Vancouver, British Columbia
About this study
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.
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.
Read the detailed description
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 experimental group.
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 problems.
- Conditions
- Sleep Problems
- Being tested
- Controlled crying and routines
- Keywords
- Cognitive and behavioural intervention, trial, group, Behavioral sleep problems
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled crying and routinesBehavioural
Behavioural (teaching and support)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Behavioral: Controlled crying and routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of infant sleep problem on a severity scale (parents' perception)
Measured: 6 & 24 weeks
Secondary outcomes (1)
Less than an average of twice a night over 5 nights by actigraphy
Measured: 6 & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Wendy Hall, RN, PhD, Principal investigator, University of British ColumbiaRadhika Bhagat, RN, MN, Study director, Vancouver Coastal HealthRollin Brant, Ph.D, Study director, Centre for Community Child Health ResearchJean Paul Collett, Ph.D, Study director, Child and Family Research InstituteAmiram Gafni, Ph.D, Study director, McMaster UniversityDorothy Hamilton, RN, BSN, Study director, Vancouver Coastal HealthEileen Hutton, Ph.D, Study director, McMaster UniversityKathy Hydamaka, RN, BSN, Study director, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877162
- Sponsor's protocol ID
- H09-00757
- Other IDs
- CIHR MCT-94836
- Status last verified
- Jun 2012
- First submitted
- 3 Apr 2009
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26567090
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00877162
- Acronym / sponsor ID
- H09-00757
- Conditions
- Sleep Problems
- Keywords
- Cognitive and behavioural intervention, trial, group, Behavioral sleep problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 experimental group.
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 problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Controlled crying and routinesProviding 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. |
Who may qualify
- Ages
- 6 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled crying and routinesBehavioural (teaching and support) | Behavioural | 1 |
Primary outcome
Severity of infant sleep problem on a severity scale (parents' perception)
Time frame: 6 & 24 weeks
1 secondary outcome
Less than an average of twice a night over 5 nights by actigraphy
Time frame: 6 & 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 26567090Hall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Hall, RN, PhD principal investigator
University of British Columbia
Radhika Bhagat, RN, MN study director
Vancouver Coastal Health
Rollin Brant, Ph.D study director
Centre for Community Child Health Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sleep Problems, run by University of British Columbia at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of infant sleep problem on a severity scale (parents' perception) (time frame: 6 & 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.