The Rocky Sleep Study
Condition: Sleep Problems
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

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.
    

Intervention name(s): Controlled crying and routines
Intervention type(s): Behavioral
Intervention description(s): Behavioural (teaching and support)
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive and behavioural intervention; trial; group; Behavioral sleep problems