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

ISRCTN	ISRCTN56892832
DOI	https://doi.org/10.1186/ISRCTN56892832
Secondary identifying numbers	N/A

Submission date: 11/12/2007
Registration date: 24/01/2008
Last edited: 31/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jon Quach
Scientific

Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Phone	+61 (0)3 9345 4812
Email	jon.quach@mcri.edu.au

Study information

Study design	Study 1: Observational; Study 2: Interventional (Randomised controlled trial)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Sleep Well - Be Well: A randomised controlled trial of a brief behaviour intervention for child sleep problems in Melbourne school children
Study acronym	"Sleep Well - Be Well" Study
Study objectives	In a sample of school children with parent reported sleep problems, a sleep intervention will result in: 1. A lower proportion of children with parent-reported sleep problems at 3, 6 and 12 months 2. Better mean child scores on concentration, behaviour and health-related quality of life at 3, 6 and 12 months 3. Better mean child scores on learning at 6 months 4. Better mean parent scores on parent mental health at 3, 6 and 12 months 5. The intervention will be feasible and acceptable for parents and schools
Ethics approval(s)	1. Royal Children's Hospital Ethics Committee. Date of approval: 11th November 2007 (ref: HREC 27132 A) 2. Victorian Department of Education and Early Childhood Development. Date of approval: 11th November 2007 (ref: SOS 003739)
Health condition(s) or problem(s) studied	Sleep problems in children
Intervention	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 to participate in the randomised controlled trial Study 2: Randomised controlled trial: Part 1: 45-minute one-on-one consultation session Part 2: 20-minute phone call 1 week later Part 3: 30-minute one-on-one consultation session (optional) Topics covered will include: overview of sleep problems, role of sleep, types of sleep problems and an individual plan for the specific child sleep problems reported by the parent. The strategies will focus on establishing good sleep hygiene including having a set bedtime and bedtime routine, keeping the child's bedroom comfortable, and avoiding TV/computers in the bedroom. Parents will complete a sleep plan for their child under the guidance of the nurse/psychology student, writing down the strategies they feel appropriate for their child's sleep problem. Control group: No intervention ("Usual care" group)
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	01/02/2008
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	2,380
Total final enrolment	1512
Key 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.
Key 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.
Date of first enrolment	01/02/2008
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Australia

Study participating centre

Centre for Community Child Health

Parkville
3052
Australia

Sponsor information

Murdoch Childrens Research Institute (MCRI) (Australia)
Hospital/treatment centre

Centre for Community Child Health
Royal Children's Hospital
Flemington Road Parkville
Victoria
3052
Australia

Website	http://www.mcri.edu.au/
"ROR"	https://ror.org/048fyec77

Funders

Funder type

Hospital/treatment centre

Royal Children's Hospital (Australia) - Centre for Community Child Health

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2011	31/12/2020	Yes	No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.