Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000317392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/02/2026
Date registered
Help: Date registered
13/03/2026
Date last updated
Help: Date last updated
13/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/03/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Better Bedtimes: A brief behavioural sleep intervention for insomnia in middle childhood
Scientific title
Better Bedtimes: efficacy and acceptability of a brief behavioural sleep intervention for insomnia in middle childhood
Additional trial identifiers [1] 316517 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
pediatric sleep difficulties 340653 0
Insomnia 340654 0
Condition category
Condition code
Mental Health 336843 336843 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Better Bedtimes study runs over an 8-week period and involves a structured, evidence-based sleep restriction therapy (SRT) program. The SRT program is delivered by a psychologist and consists of two sessions spaced one week apart (Session 1: 30–45 minutes, Session 2: 30 minutes) delivered either face-to-face at Macquarie University Emotional Health Clinic or via Zoom. Families track child sleep patterns using a daily diary for one week at baseline (Week 1), during active treatment (Week 2 & 3), immediately post-treatment (Week 4), and at a 4-week follow-up (Week 8). Using baseline data, the psychologist calculates the child’s average total sleep time (TST) and temporarily restricts time in bed to TST minus 15 minutes, ensuring it does not drop below a safe threshold. A consistent wake time is maintained, and bedtime is adjusted accordingly. Time in bed is gradually increased in small increments until an optimal schedule is achieved. Families are given a workbook after the first appointment which includes psychoeducation on sleep processes and the science of sleep restriction therapy. Adherence is monitored via session attendance and sleep diary reviews.
Intervention code [1] 333180 0
Behaviour
Intervention code [2] 333181 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344362 0
Sleep onset latency
Timepoint [1] 344362 0
Pre-treatment, week 1, week 2, post-treatment, 4- week follow-up
Primary outcome [2] 344363 0
The Sleep Disturbance Scale for Children (SDSC) insomnia subscale
Timepoint [2] 344363 0
Application, pre-treatment, post-treatment and 4-week follow-up
Primary outcome [3] 344636 0
Wake after sleep onset,
Timepoint [3] 344636 0
Pre-treatment, week 1, week 2, post-treatment, 4- week follow-up
Secondary outcome [1] 457630 0
The Patient-Reported Outcomes Measurement Information System (PROMIS) – Sleep-Related Impairment – Short Form
Timepoint [1] 457630 0
Pre-treatment, post-treatment and 4-week follow-up
Secondary outcome [2] 457631 0
The Spence Children’s Anxiety Scale
Timepoint [2] 457631 0
Pre-treatment, post-treatment and 4-week follow-up
Secondary outcome [3] 457632 0
The World Health Organization-Five Well-Being Index (WHO-5)- parent stress
Timepoint [3] 457632 0
Pre-treatment, post-treatment and 4-week follow-up
Secondary outcome [4] 457633 0
Treatment satisfaction (assessed using a 5-point likert scale ranging from 'very dissatisfied' to 'very satisfied'.)
Timepoint [4] 457633 0
Post-treatment
Secondary outcome [5] 457634 0
The Barriers to Treatment Questionnaire
Timepoint [5] 457634 0
Post-treatment
Secondary outcome [6] 458027 0
Total sleep time
Timepoint [6] 458027 0
Pre-treatment, week 1, week 2, post-treatment, 4- week follow-up
Secondary outcome [7] 458701 0
Average number of awakenings- Primary outcome
Timepoint [7] 458701 0
Pre-treatment, week 1, week 2, post-treatment, 4- week follow-up
Secondary outcome [8] 458702 0
Sleep efficiency
Timepoint [8] 458702 0
Pre-treatment, week 1, week 2, post-treatment, 4- week follow-up
Secondary outcome [9] 458703 0
Presence and severity of DSM-5 mental health disorders
Timepoint [9] 458703 0
Pre-treatment

Eligibility
Key inclusion criteria
Currently living in Australia
Child aged between 6 and 11 years with at least one caregiver who can attend all treatment sessions. Caregivers must be a legal guardian with the authority to provide informed consent for the child’s participation. Other adults (such as grandparents, aunts, uncles, or similar) may take part in the study alongside the child if the legal guardian provides consent for their involvement.
Child must meet criteria for insomnia disorder as determined through structured diagnostic clinical interview. Those who meet all criteria but do not reach signifiant impairment will also be incldued.
Able to provide informed consent.
Minimum age
6 Years
Maximum age
11 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Neurodevelopmental disorder (e.g. ADHD, Autism)
Evidence of a sleep disorder (e.g., restless legs syndrome, sleep apnoea) that is the primary cause of insomnia symptoms
Actively suicidal or unable to keep themselves safe
Receiving concurrent psychological therapy
Not on a stable dose of medication (if applicable)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To assess improvements in both sleep-related outcomes (i.e., insomnia symptoms) and non-sleep-related outcomes (i.e., caregiver stress levels, child daytime functioning), Generalized Estimating Equations (GEE) will be used to model symptom change from pre-treatment to post-treatment and 4-week follow-up. Analyses will be conducted using intention-to-treat principles, with multiple imputation applied to manage missing data. The role of anxiety as a moderator of treatment outcomes will be explored by including interaction terms in the GEE models. Categorical variables will be analysed using chi-squared tests, while continuous variables will be assessed using parametric or non-parametric tests as appropriate. Treatment efficacy and acceptability will be evaluated through participant ratings on a post-treatment questionnaire. Effect sizes will be reported to quantify the magnitude of changes, and clinical significance will be assessed using reliable change indices where applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/10/2025
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
65
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321130 0
University
Name [1] 321130 0
Macquarie University Graduate Research Fund
Country [1] 321130 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 323837 0
None
Name [1] 323837 0
None
Address [1] 323837 0
Country [1] 323837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319661 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 319661 0
Ethics committee country [1] 319661 0
Australia
Date submitted for ethics approval [1] 319661 0
13/03/2025
Approval date [1] 319661 0
27/06/2025
Ethics approval number [1] 319661 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148026 0
Dr Lauren McLellan
Address 148026 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 148026 0
Australia
Phone 148026 0
+61 2 9850 1463
Fax 148026 0
Email 148026 0
[email protected]
Contact person for public queries
Name 148027 0
Taylor Hathway
Address 148027 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 148027 0
Australia
Phone 148027 0
+61 2 98508602
Fax 148027 0
Email 148027 0
[email protected]
Contact person for scientific queries
Name 148028 0
Taylor Hathway
Address 148028 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 148028 0
Australia
Phone 148028 0
+61 2 98508602
Fax 148028 0
Email 148028 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• The data collected in this project may be used in future research by the research team and those who directly collaborate with the resarch team only.

Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Lauren McLellan- [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.