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Sleep Well - Be Well: A randomised controlled trial of a brief behaviour intervention for child sleep problems in Melbourne school children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56892832
Enrollment
2380
Registered
2008-01-24
Start date
2008-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep problems in children Signs and Symptoms Sleep problems in children

Interventions

30 State primary schools across Melbourne are involved. Study 1: Observational - Questionnaire distribution to 2,380 Melbourne school students Study 2: Interventional - Invited parents from Part 1

Sponsors

Murdoch Childrens Research Institute (MCRI) (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All students who are attending the first year of primary school will be distributed a survey and asked to be part of the study at baseline. 2. Primary care givers will be invited to participate in the study if the baseline questionnaire is returned, and that they indicate that the child has a moderate or severe sleep problem.

Exclusion criteria

Exclusion criteria: 1. Children with major malformations or medical conditions (e.g., Blindness, Down's Syndrome). 2. Parents with insufficient English to complete questionnaires. 2. Parents of children who score high in the sleep apnoea questionnaire items from the Child Sleep Habits Questionnaire at baseline will be contacted by Dr Hiscock to clarify the nature of their sleep problem. If Dr Hiscock is concerned that the child may have sleep apnoea, she will explain this to the family and suggest they are reviewed in the Sleep Clinic at the Centre for Community Child Health. These children will be excluded from the intervention study as behavioural interventions are not standard treatment for sleep apnoea. Based on data from prevalence studies, we anticipate that only 2% or about 40 children may have this problem.

Design outcomes

Primary

MeasureTime frame
How much is your child's sleeping pattern or habits a problem for you?(none/mild/moderate/severe) (Timepoints: B, 3, 6, 12) B = Baseline E = Enrolment 3 = 3 Month follow-up 6 = 6 Month follow-up 12 = 12 Month follow-up

Secondary

MeasureTime frame
1. Children's Sleep Habits Questionnaire (Abbreviated) ? a validated 33-item questionnaire which focuses on dyssomnias, parasomnias and sleep-disordered breathing problems in children aged 4-12 years old (Timepoints: E, 6, 12) 2. Paediatric Quality of Life Inventory™ (PedsQL™) - a validated 23-item questionnaire measuring quality of life which focuses on the child's physical, emotional, social and school functioning (Timepoints: B, 3, 6, 12) 3. Strength and Difficulties Questionnaire - a validated 25-item questionnaire that focuses on the child's emotional conduct, hyperactivity, inattention, peer relationship and prosocial behavior (Timepoints: B, 6, 12) 4. Depression Anxiety Stress Scale (Abbreviated) - a validated 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress of the parent (Timepoints: B, 3, 6, 12) 5. Conners' Parent Rating Scale - Revised: Short form - a validated 27-item questionnaire that measures a child's behaviour in the areas of opposition, cognitive problems/inattention, hyperactivity and Attention-Deficit/Hyperactivity Disorder (ADHD) Index (Timepoints: E, 3, 6, 12) 6. Weschler Individual Achievement Test (WIAT)-II Australian (Abbreviated) - A face-to-face assessment tool which identifies basic academic skills and intervention needs in children. It has three subtests of spelling, word reading and numerical operations (Timepoint: 6) 7. Impact on parent work life, measured through parent report of how many times they were late or missed work due to their child's sleep problem (Timepoints: E, 3, 6, 12) B = Baseline E = Enrolment 3 = 3 Month follow-up 6 = 6 Month follow-up 12 = 12 Month follow up

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026