Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000178347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/12/2025
Date registered
Help: Date registered
11/02/2026
Date last updated
Help: Date last updated
15/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/02/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
“Nighttime Fears and Worries” Program – Early testing of a new parent-led digital approach to help children with nighttime fears and sleep
Scientific title
Nighttime Fears and Worries” program – A digital exposure-focused intervention for children with nighttime fears: A Pilot Intervention Acceptability and Feasibility Study
Additional trial identifiers [1] 316079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Nighttime Fears 339947 0
Anxiety 339948 0
Sleep 339949 0
Condition category
Condition code
Mental Health 336176 336176 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Nighttime Fears and Worries Intervention is an approximately 8–10 week digital program designed to help parents and children reduce nighttime fears and associated anxiety. The intervention is delivered through an app accessible via mobile or web browser. It consists of exposure activities and modules, including (a) up to 5 parent-only modules and (b) up to 3 parent-and-child modules. These modules incorporate core therapeutic components such as psychoeducation about nighttime fears, information about exposure, parent training, and sleep hygiene. Families are encouraged to practice their exposure activities daily.

The core intervention runs for around 8 weeks. Modules typically take approximately 10–60 minutes to complete, depending on content and participant engagement. Content is delivered through a combination of text, videos, examples, and interactive digital activities.Families may be offered an optional 2-week bedtime fading component after the core program if persistent sleep difficulties are identified and parents express interest. This component primarily delivers bedtime fading strategies. If eligible, parents will complete a daily sleep diary to inform personalised bedtime fading adjustments. Bedtime fading is a sleep treatment involves temporarily moving the child’s bedtime to closely coincide the child’s natural sleep onset, in order to improve sleep onset and sleep maintenance.

Procedures
Participants will complete screening and consent before starting the program. After baseline assessment, families will access the intervention digitally and complete modules and activities at home. Optional sleep modules will be offered at the end of the core program. Post-intervention assessments will occur after completion of the core program and any optional modules, with follow-up approximately 3 months later.
Up to two brief telehealth sessions (approximately 20–30 minutes) will be provided early and mid-program to support engagement and troubleshoot difficulties. Families completing the optional sleep module may receive an additional support session.

Design
The intervention is parent-led and delivered individually via a digital platform. Therapist support is delivered by an AHPRA-registered psychologist using a structured guide. The program is accessed online via app or web browser and completed at home.

Personalisation
Exposure tasks and bedtime fading strategies will be tailored based on participant responses and sleep diary data.

Adherence and Fidelity
App usage will be tracked automatically, and reminders will be sent via digital channels (e.g., email, SMS, push notifications) to support engagement. Therapist sessions will follow a structured guide, and a proportion will be reviewed for fidelity.
Intervention code [1] 332690 0
Behaviour
Intervention code [2] 332752 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343726 0
Acceptability
Timepoint [1] 343726 0
Post-intervention (week 8)
Primary outcome [2] 343727 0
Feasibility
Timepoint [2] 343727 0
App usage and consent rates will be monitored throughout the intervention period and summarised at post-intervention (week 8) and follow-up (week 12) Consent rate: At end of recruitment Adherence: At post-intervention (week 8) Engagement: At post-intervention (Summarised per week up until week 8) Attrition: At post-intervention (week 8 and 12) Retention: At post-intervention and follow-ups (week 8 and 12)
Secondary outcome [1] 455421 0
Potential effectiveness (Anxiety)
Timepoint [1] 455421 0
Baseline, week 8 and week 12 post-intervention commencement
Secondary outcome [2] 455732 0
Potential effectiveness (Sleep)
Timepoint [2] 455732 0
Baseline, week 8 and week 12 post-intervention commencement
Secondary outcome [3] 457250 0
Potential effectiveness (Anxiety)
Timepoint [3] 457250 0
Baseline, week 8 and week 12 post-intervention commencement
Secondary outcome [4] 457251 0
Potential effectiveness (Sleep)
Timepoint [4] 457251 0
Week 8-10
Secondary outcome [5] 457571 0
Potential effectiveness (Sleep)
Timepoint [5] 457571 0
Week 8-10
Secondary outcome [6] 457572 0
Potential Effectiveness (Sleep)
Timepoint [6] 457572 0
Week 8, 9, 10 and 12 post-intervention commencement
Secondary outcome [7] 457573 0
Potential Effectiveness (Sleep)
Timepoint [7] 457573 0
Week 8-10
Secondary outcome [8] 463152 0
Acceptability (Bedtime fading component)
Timepoint [8] 463152 0
Week 12

Eligibility
Key inclusion criteria
Children and their parent/carer will be included based on the following criteria and assessed through parent-report:
• Children aged 7-12 years
• Children with nighttime fears
• Children with sleep disturbances
• Capacity to answer questions independently or with assistance if needed, and
• Participants require access to a device (e.g. mobile, laptop or iPad) and internet to use the digital program.

Inclusion criteria for parents:
• Parent/carer of a child who meets inclusion criteria above
• Capacity to support their child through the intervention e.g., sufficient English comprehension capacity to complete the study
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
The following exclusion criteria will be based on parent-report:
• Children with behavioural or attentional difficulties that are likely to interfere with participation in exposure and bedtime fading (e.g., severe ODD, conduct problems, or ADHD symptoms exceeding anxiety severity) will be excluded.
• Child has a diagnosed intellectual disability
• Symptoms of obstructive sleep apnea
• Child is currently receiving any psychological therapy (other than school counsellor support), i.e., seeing a psychologist for and/or using a CBT-based program (e.g., Cool Kids or BRAVE) for psychological support
o Note: child will be eligible if they are receiving other types of (i.e., non-CBT-based) psychological treatment, including supportive counselling
• Child recently started taking medications, has plans to start initiating medication, or changing medication for anxiety during the intervention
o Note: child will be eligible if their medication is stable across the intervention
• Child is reported to have life-threatening suicidal ideation and/or had serious suicidal ideation in the last month.
• Previously or currently completing the Courage Quest pilot study or efficacy trial
• Parent/carer is unable or unwilling to provide informed consent or participate in study activities


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/02/2026
Actual
9/04/2026
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320676 0
Charities/Societies/Foundations
Name [1] 320676 0
Australian Rotary Health
Country [1] 320676 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 323313 0
None
Name [1] 323313 0
Address [1] 323313 0
Country [1] 323313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319218 0
The University of New South Wales Committee C
Ethics committee address [1] 319218 0
Ethics committee country [1] 319218 0
Australia
Date submitted for ethics approval [1] 319218 0
13/10/2025
Approval date [1] 319218 0
21/11/2025
Ethics approval number [1] 319218 0
iRECS10049

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

Contacts
Principal investigator
Name 146642 0
Dr Melissa Aji
Address 146642 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 146642 0
Australia
Phone 146642 0
+61290659173
Fax 146642 0
Email 146642 0
[email protected]
Contact person for public queries
Name 146643 0
Melissa Aji
Address 146643 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 146643 0
Australia
Phone 146643 0
+61290659173
Fax 146643 0
Email 146643 0
[email protected]
Contact person for scientific queries
Name 146644 0
Melissa Aji
Address 146644 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 146644 0
Australia
Phone 146644 0
+61290659173
Fax 146644 0
Email 146644 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.