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Trial registered on ANZCTR


Registration number
ACTRN12618001161213
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
13/07/2018
Date last updated
13/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating Sleep Problems in Preschoolers: Improving Mental Health, the Transition to School, and Academic Outcomes
Scientific title
Treating Sleep Problems in Preschoolers: Improving Mental Health, the Transition to School, and Academic Outcomes
Secondary ID [1] 293499 0
None
Universal Trial Number (UTN)
U1111-1206-1048
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transition to primary school 305686 0
Sleep problems 307807 0
Condition category
Condition code
Mental Health 304907 304907 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Behavioural Sleep Program (BSP) will consist of 5 x 1.5 hour weekly parent sessions conducted in small groups of 6-8 parents (one or both parents will be welcome) at each site. The BSP includes psychoeducation on sleep and sleep hygiene, and teaches parents strategies to implement a wind-down routine, ensure a consistent bed and wake time, develop sleep-related behaviour charts and exposure hierarchies, and deal with bedtime fears, oppositional child bed-time behaviour, co-sleeping and night-time wakening.
Clinicians will be provisionally registered Psychologists undertaking postgraduate clinical training at each site. They will receive 6 hours of training by A/Prof Caroline Donovan to ensure identical training across sites. Clinicians will be supervised by A/Prof Donovan and Prof Waters (Mt Gravatt site), Prof Gradisar (Adelaide site) and A/Prof Farrell (Gold Coast site), all of whom are fully registered Clinical Psychologists. To ensure consistency across sites, supervision will be conducted via Zoom across sites and ‘supervision of supervision’ will be conducted by A/Prof Donovan to monitor the supervision of other supervisors. Furthermore, all treatment sessions will be video-taped and independently assessed for treatment fidelity and adherence.
Intervention code [1] 299737 0
Behaviour
Intervention code [2] 299738 0
Treatment: Other
Comparator / control treatment
Parents in the Care-as-Usual (CAU) condition will be able to access any other child sleep services available during the course of the study. They will be offered the BSP after the final follow-up in term 4 of Prep/Reception. Service usage will be assessed at each time-point and referrals will be given to families if they are having difficulty accessing care at any time.
Control group
Active

Outcomes
Primary outcome [1] 304101 0
Transition to school - as assessed by:

1. The Australian Early Development Instrument (Brinkman et al., 2007)

2. Academic achievement as assessed by teachers' assessment of the child against Foundation literacy and numeracy Australian curriculum standards.

Timepoint [1] 304101 0
Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention; primary endpoint) and Term 4 (12 months post intervention)
Primary outcome [2] 305817 0
Child sleep problems - as assessed by the Child Sleep Habits Questionnaire (Owens et al., 2000) and a sleep diary.
Timepoint [2] 305817 0
Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention; primary endpoint) and Term 4 (12 months post intervention)
Secondary outcome [1] 340984 0
Emotional mental health problems as assessed by:

1. The Pre-school Anxiety Scale (Spence et al., 2001)

2. The Anxious/Depressed, Withdrawn/Depressed, and Somatic Complaints subscales of the Child Behaviour Checklist (Achenbach, 2001).
Timepoint [1] 340984 0
Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention) and Term 4 (12 months post intervention)
Secondary outcome [2] 340986 0
Behavioural mental health problems as assessed by:

1. The Eyberg Child Behaviour Inventory (Eyberg, 1978).

2. The Attention, Rule-Breaking Behaviour, and Aggressive Behaviour subscales of the Child Behaviour Checklist (Achenbach, 2001).
Timepoint [2] 340986 0
Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention) and Term 4 (12 months post intervention)

Eligibility
Key inclusion criteria
Children will be included in the study if they a) score above 41 on the Child Sleep Habits Questionnaire, and b) are rated as having a ‘moderate’ to ‘severe’ sleep problem through parent report on the screening survey. Parents must be willing to participate in either of the two conditions, consent to being filmed, and complete online assessments.
Minimum age
4 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded from the study if they have a parent-reported intellectual or developmental disorder, as the Behavioural Sleep Program is designed for neurotypical children. Children must not have commenced their first year of formal full-time schooling.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed using a central randomisation unit
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via Griffith University’s central Randomisation Unit, a web-based service that will ensure both independent randomisation and allocation concealment until study entry. Randomisation (participant level) will be a 1:1 ratio between groups with randomly varied block sizes, and stratification by site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Hypotheses pertaining to the reduction of sleep and mental health problems will be tested using a combination of chi square analyses and hierarchical linear modelling (HLM). Specifically, the binary outcome of sleep problem vs no sleep problem will be examined and reported using chi-square analyses for each assessment occasion. The continuous sleep and mental health outcome measures will be analysed using an intent-to-treat approach with repeated measures, mixed model, HLM, taking time as a within-subjects effect and treatment arm as a between subjects effect. HLM accounts for group and site within the analyses. The mediating effects of sleep on mental health and transition/academic outcomes will be tested in line with recommendations by Kenny et al, using longitudinal mediation techniques within the overall mixed model analyses.
Power calculations are conservatively based on chi-square tests using ‘sleep problem’ vs ‘no sleep problem’ as the outcome measure for effects between the two conditions. Although we expect a large effect size for sleep problems, we expect a moderate effect for mental health problems. Using G-power, we calculate that a sample size of 144 participants (72 per condition) will provide a power of .80 to detect a medium effect size of w=.30, at an alpha of .05. Allowing for an attrition rate of 20% (based on our previous work), we will require approximately 180 participants (90 per condition) across the two conditions. These sample sizes will also allow sufficient power to investigate the mediation hypotheses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment postcode(s) [1] 18201 0
4122 - Mount Gravatt
Recruitment postcode(s) [2] 18202 0
4215 - Southport
Recruitment postcode(s) [3] 18203 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 298120 0
Charities/Societies/Foundations
Name [1] 298120 0
Australian Rotary Health
Address [1] 298120 0
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150
Country [1] 298120 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Road,
Mt Gravatt QLD 4122,

Country
Australia
Secondary sponsor category [1] 297200 0
University
Name [1] 297200 0
Flinders University
Address [1] 297200 0
Sturt Rd, Bedford Park SA 5042
Country [1] 297200 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299137 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 299137 0
Office for Research
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 299137 0
Australia
Date submitted for ethics approval [1] 299137 0
29/11/2017
Approval date [1] 299137 0
01/12/2017
Ethics approval number [1] 299137 0
2017/962

Summary
Brief summary
Sleep problems in the preschool years represent a transdiagnostic risk factor for numerous child mental health and academic problems, in the short- and long-term. Given that sleep problems are modifiable, successful treatment before children begin primary school will reduce child sleep and mental health problems, improve the transition to primary school, and enhance academic outcomes.

We aim to conduct a large-scale, multi-site study through a randomised controlled trial (RCT) investigating the efficacy of a parent-focused, group-based behavioural sleep program (BSP) delivered BEFORE children begin primary school targeting preschool sleep problems. Relative to care-as-usual (CAU), we expect the BSP will reduce child sleep and mental health problems, and improve school transition and academic outcomes. Participants in both conditions will be assessed before and after the treatment phase, as well as at the end of terms 1 and 4 of the first year of primary school. The following hypotheses are proposed:

1. Compared to children in the CAU condition, children whose parents participate in the BSP program will exhibit a significantly greater reduction in sleep problems at post-assessment, and terms 1 and 4 of Prep/Reception;

2. Compared to children in the CAU condition, children whose parents participate in the BSP program will exhibit a significantly greater reduction in emotional and behavioural mental health outcomes (i.e., anxiety symptoms, depression symptoms, somatic complaints, rule breaking behaviour, attention problems, aggression, and oppositional behaviour) at post-assessment, term 1 and term 4 of Prep/Reception.

3. Sleep outcomes will mediate the effect of treatment arm on mental health outcomes. That is, improvements in child sleep problems (measured at post-assessment) will lead to improvements in mental health outcomes for the BSP relative to the CAU group at post-assessment, term1 and term 4 assessment points.

4. Sleep outcomes will also mediate the effect of treatment arm on child school transition and academic outcomes. That is, improvements in child sleep problems (measured at post-assessment) will lead to improvements in school transition and academic outcomes for the BSP condition relative to the CAU group at term 1 and term 4 assessment points.

During this three-year project, two cohorts will be recruited in Years 1 and 2 of the study. In the final quarter of the year prior to commencement of primary school, parents of preschool children with sleep problems will be randomised to BSP and CAU conditions and those in the BSP condition will receive treatment. Outcomes from this study will provide new directions for improving sleep, mental health problems, and preparedness for early major life transitions in young Australians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79422 0
A/Prof Caroline Donovan
Address 79422 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 79422 0
Australia
Phone 79422 0
+61 7 3735 3401
Fax 79422 0
Email 79422 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 79423 0
A/Prof Caroline Donovan
Address 79423 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 79423 0
Australia
Phone 79423 0
+61 7 3735 3401
Fax 79423 0
Email 79423 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 79424 0
A/Prof Caroline Donovan
Address 79424 0
Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122
Country 79424 0
Australia
Phone 79424 0
+61 7 3735 3401
Fax 79424 0
Email 79424 0
c.donovan@griffith.edu.au

No data has been provided for results reporting
Summary results
Not applicable