Clinical trial NCT00877162: The Rocky Sleep 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Problems
Keywords: Cognitive and behavioural intervention
trial
group
Behavioral sleep problems
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-04-07
Enrollment: 235
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Severity of infant sleep problem on a severity scale (parents' perception)
timeFrame: 6 & 24 weeks
Secondary outcomes:
measure: Less than an average of twice a night over 5 nights by actigraphy
timeFrame: 6 & 24 weeks
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Richmond Community Health Services
state: British Columbia
city: Vancouver
country: Canada
facility: North Shore Coastal Community Health
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Spirit Community Health Centre
state: British Columbia
city: Vancouver
country: Canada
facility: South Community Health Office
state: British Columbia
city: Vancouver
country: Canada
facility: Three Bridges Community Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wendy Hall, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vancouver Coastal Health
name: Radhika Bhagat, RN, MN
role: STUDY_DIRECTOR
affiliation: Centre for Community Child Health Research
name: Rollin Brant, Ph.D
role: STUDY_DIRECTOR
affiliation: Child and Family Research Institute
name: Jean Paul Collett, Ph.D
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Amiram Gafni, Ph.D
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Dorothy Hamilton, RN, BSN
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Eileen Hutton, Ph.D
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Kathy Hydamaka, RN, BSN
role: STUDY_DIRECTOR
affiliation: Sunny Hill Health Centre for Children
name: Osman Ipsiroglu, MD
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health Research Institute
name: Valerie Munroe, RN, MSN
role: STUDY_DIRECTOR
affiliation: Seymour Medical Clinic
name: Roy Saunders, MD
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Kathy Triolet, RN, BSN
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Lillian Tse, RN, MSN
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Joanne Wooldridge, RN, MSN
role: STUDY_DIRECTOR
References:
citation: 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.