ANZCTR - Registration

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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

7/08/2020

Date data sharing statement initially provided

17/06/2019

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]

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

Sleep problems

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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 2 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]

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]

Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention; primary endpoint) and Term 2 (9 months post intervention).

Primary outcome [2]

Child sleep problems - as assessed by the Child Sleep Habits Questionnaire (Owens et al., 2000) and a sleep diary.

Timepoint [2]

Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention; primary endpoint) and Term 2 (9 months post intervention)

Secondary outcome [1]

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]

Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention) and Term 2 (9 months post intervention)

Secondary outcome [2]

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]

Initial follow up assessment (2 weeks post intervention), end of Term 1 (6 months post intervention) and Term 2 (9 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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

31/07/2018

Actual

31/07/2018

Date of last participant enrolment

Anticipated

13/10/2019

Actual

9/10/2019

Date of last data collection

Anticipated

1/12/2020

Actual

23/10/2019

Sample size

Target

180

Accrual to date

Final

130

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4122 - Mount Gravatt

Recruitment postcode(s) [2]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

176 Messines Ridge Road,
Mt Gravatt QLD 4122,

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Rd, Bedford Park SA 5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/11/2017

Approval date [1]

01/12/2017

Ethics approval number [1]

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 2 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 2 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 2 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 2 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 2 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

A/Prof Caroline Donovan

Address

Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122

Country

Australia

Phone

+61 7 3735 3401

Fax

c.donovan@griffith.edu.au

Contact person for public queries

Name

Caroline Donovan

Address

Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122

Country

Australia

Phone

+61 7 3735 3401

Fax

c.donovan@griffith.edu.au

Contact person for scientific queries

Name

Caroline Donovan

Address

Griffith University Mt Gravatt Campus
School of Applied Psychology
176 Messines Ridge Road, Mt Gravatt QLD 4122

Country

Australia

Phone

+61 7 3735 3401

Fax

c.donovan@griffith.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Treating sleep problems in young children: A randomised controlled trial of a group-based, parent-focused behavioural sleep intervention.	2023	https://dx.doi.org/10.1016/j.brat.2023.104366

N.B. These documents automatically identified may not have been verified by the study sponsor.

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