Condition category
Signs and Symptoms
Date applied
11/12/2007
Date assigned
24/01/2008
Last edited
07/03/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jon Quach

ORCID ID

Contact details

Centre for Community Child Health
Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 (0)3 9345 4812
jon.quach@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

"Sleep Well - Be Well" Study

Study hypothesis

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

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)

Study design

Study 1: Observational; Study 2: Interventional (Randomised controlled trial)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2008

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2,380

Participant 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.

Recruitment start date

01/02/2008

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Community Child Health
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (MCRI) (Australia)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.mcri.edu.au/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes