Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000293369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/02/2026
Date registered
Help: Date registered
6/03/2026
Date last updated
Help: Date last updated
11/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Trialling Lights Out in Paediatric Outpatient Services
Scientific title
Meeting an Urgent Community Need: An Effectiveness-Implementation Trial of Lights Out in Paediatric Outpatient Services
Additional trial identifiers [1] 316485 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Child sleep problems 340614 0
Child anxiety problems 340886 0
Condition category
Condition code
Mental Health 336808 336808 0 0
Other mental health disorders
Mental Health 337044 337044 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
A caregiver-focused behavioural sleep intervention adapted for delivery via group-based videoconference sessions will be implemented in the paediatric outpatient services. The group size and the number of sessions will be determined through a stakeholder-informed adaptation process before the trial starts. This phase of the project will involve qualitative interviews with key stakeholders (caregivers, hospital clinicians and administrators) to gather their perspectives and recommendations to inform adaptation of the Lights Out program for paediatric outpatient settings. Interview sessions will focus on gathering participant perspectives on:
• the preferred delivery format of the program;
• presentation and accessibility of program content;
• practical considerations for use within paediatric outpatient services; and
• perceived barriers and facilitators to program delivery.
Participants may take part in the adaptation process through either group or individual interviews, depending on their availability and preference. Interviews should take approximately 30 minutes in an individual format or 60-90 minutes in a group format.

The original Lights Out program (Donovan et al., 2023) incorporates standard paediatric sleep strategies alongside gold standard treatment strategies targeting bedtime fears (i.e. exposure hierarchies) and behavioural problems at bedtime (i.e., clear instructions, time-out, and limit-setting). Caregivers are trained to support their child in gradually managing bedtime fears through the Lights Out Ladder, which involves collaboratively developing a graded exposure hierarchy. The Lights Out Ladder is a step-by-step plan designed to gradually reduce fear. It involves listing situations that trigger fear, ranking them from least to most fearful, and then helping the child face these situations progressively. The original program was delivered weekly over 6 weeks and comprised of five 1.5-hour face-to-face group sessions. For the purposes of current trial, Lights Out Modified (LOM) will be delivered via group-based videoconference sessions using Microsoft Teams, reflecting the service delivery constraints of the participating hospitals. Sessions will be delivered to caregivers only (children will not attend).

Consistent with the original program, LOM will follow a structured, manualised program based on cognitive-behavioural therapy principles. The program will include psychoeducation on sleep and sleep hygiene; will provide training in sleep routines, bedtime fading, praise and rewards; will teach strategies for dealing with night-time fears and for dealing with difficult behaviours. Two developmentally appropriate versions of the program will be delivered: one for caregivers of children aged 3-6 years and one for caregivers of children aged 7-12 years.

LOM groups will be facilitated by provisionally registered psychologists external to the hospital (i.e., trial therapists). All trial therapists will receive standardised training (minimum of 5 hours) in the LOM protocol delivered by Principal Investigator Donovan prior to commencing intervention delivery. Trial therapists will also participate in weekly 2-hour group supervision sessions led by the members of the investigative team who are fully registered Clinical Psychologists (Donovan, Farrell, and Winter), throughout the intervention period. Session attendance and homework adherence will be monitored and recorded by the LOM group therapists for each participant. All treatment sessions will be video-taped and independently assessed for treatment fidelity.
Intervention code [1] 333147 0
Behaviour
Intervention code [2] 333148 0
Treatment: Other
Description of the comparator or control
Parents in the Care-as-Usual (CAU) condition will be able to access any other usual services available during the course of the trial. These may include, for example, consultation with a general practitioner or paediatrician or support from school guidance counselling services. Following completion of the final assessment, participants allocated to the CAU condition will be offered access to the LOM program. At that time, participants may choose to complete the program online in a self-directed format or via group videoconference, according to their preference.
Control group
Active

Outcomes
Primary outcome [1] 344326 0
Child sleep problems
Timepoint [1] 344326 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [1] 457495 0
Child anxiety problems
Timepoint [1] 457495 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [2] 457496 0
Child behavioural problems
Timepoint [2] 457496 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [3] 457497 0
Health-related quality of life
Timepoint [3] 457497 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [4] 457498 0
Caregiver mental health
Timepoint [4] 457498 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [5] 457499 0
Caregiver self-efficacy
Timepoint [5] 457499 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [6] 457500 0
Caregiver sleep problems
Timepoint [6] 457500 0
Baseline, 3 months post-baseline, and 6 months post-baseline
Secondary outcome [7] 457501 0
Program Satisfaction and Acceptability (This will be assessed as a composite outcome)
Timepoint [7] 457501 0
3 months post-baseline

Eligibility
Key inclusion criteria
Caregivers:
To be included in the study, caregiver participants must meet the following criteria:
• Be a parent or legal guardian aged 18 years or older.
• Be able to provide informed consent and participate in the intervention and study procedures.
• Have at least one child with a developmental age between 3 and 12 years who is accessing (on the waitlist or currently receiving) paediatric outpatient services at study sites.
• The child must score 41 or higher on the CSHQ, indicating clinically significant behavioural child sleep problems that are not primarily respiratory in nature.

Trial therapists:
To be eligible to participate in the program satisfaction and acceptability survey, trial therapists must meet the following criteria:
• Be aged 18 or over.
• Be a registered or provisionally registered Psychologists external to the hospital services.
• Have received standardised training (minimum of 5 hours) in the LOM protocol delivered by Principal Investigator Donovan prior to commencing intervention delivery and participated in weekly 2-hour group supervision sessions led by the investigative team.
• Have delivered the full LOM program to least one LOM group during the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Caregiver participants will be excluded from the study if any of the following apply:
• The caregiver is unable to provide informed consent due to limited understanding or comprehension of the study procedures.
• The caregiver does not have sufficient English proficiency to complete study measures or participate in the intervention, and an interpreter is not available.
• The child has a diagnosed or suspected primary sleep disorder of respiratory origin (e.g., obstructive sleep apnoea), as indicated by clinical history or screening responses.
• The child has a diagnosed intellectual or developmental disability that would significantly limit their caregiver’s ability to engage with the intervention content, as indicated by clinical history or screening responses.
• The child is currently receiving psychological or psychiatric treatment specifically targeting sleep problems that would conflict with participation in the study.
• The child has commenced or had changes to sleep-related or psychotropic medication within the six weeks prior to enrolment, such that medication effects are not yet stabilised.

The trial therapists will be excluded from participating if they:
• Did not actively engage in the delivery of LOM.

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)
Participants will be randomised after screening and baseline measures have been completed. Randomisation will be performed by a researcher independent of the project using a web-based randomisation schedule. Members of the research team do not have access to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre-generated using permuted block randomisation with variable block sizes by an independent researcher.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
1/10/2027
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 321096 0
Charities/Societies/Foundations
Name [1] 321096 0
Australian Rotary Health
Country [1] 321096 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 323803 0
None
Name [1] 323803 0
Address [1] 323803 0
Country [1] 323803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319632 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 319632 0
Ethics committee country [1] 319632 0
Australia
Date submitted for ethics approval [1] 319632 0
10/02/2026
Approval date [1] 319632 0
28/04/2026
Ethics approval number [1] 319632 0
HREC/2026/MNH/126017

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

Contacts
Principal investigator
Name 147926 0
Prof Caroline Donovan
Address 147926 0
Griffith University School of Applied Psychology 170 Kessels Road Nathan 4111 QLD
Country 147926 0
Australia
Phone 147926 0
+61 7 3735 3401
Fax 147926 0
Email 147926 0
[email protected]
Contact person for public queries
Name 147927 0
Caroline Donovan
Address 147927 0
Griffith University School of Applied Psychology 170 Kessels Road Nathan 4111 QLD
Country 147927 0
Australia
Phone 147927 0
+61 7 3735 3401
Fax 147927 0
Email 147927 0
[email protected]
Contact person for scientific queries
Name 147928 0
Caroline Donovan
Address 147928 0
Griffith University School of Applied Psychology 170 Kessels Road Nathan 4111 QLD
Country 147928 0
Australia
Phone 147928 0
+61 7 3735 3401
Fax 147928 0
Email 147928 0
[email protected]

Data sharing statement
Will the study consider sharing 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.