Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000049471
Ethics application status
Approved
Date submitted
19/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Lights Out Online: Examining the Efficacy of Therapist Assistance via Videoconference in Parents of Young Children with Behavioural Sleep Problems
Scientific title
Examining the Efficacy of a therapist assisted videoconferencing adjunct to the Lights Out Online CBT program in improving child behavioural sleep problems and parent mental health
Secondary ID [1] 313589 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 336119 0
Depression 336120 0
Anxiety 336121 0
Stress 336122 0
Condition category
Condition code
Mental Health 332672 332672 0 0
Other mental health disorders
Mental Health 332791 332791 0 0
Anxiety
Mental Health 332792 332792 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Online Treatment Program (Lights Out Online) consists of four online modules for parents of young people with behavioural sleep problems. Only parents will have access to the program. All therapy content is based on cognitive behavioural therapy and embedded within the program, and online modules are engaging and interactive with the use of images, videos, interactive elements, and quizzes that provide immediate feedback. Each session takes maximum 45 minutes to complete. The first module focuses psychoeducation and sleep hygiene. The second module focuses on bedtime routines, and tips on how best to praise and reward children. The third module focuses on anxiety at bedtime, and includes exposure and relaxation. The fourth module focuses on oppositional behaviour at bedtime, including strategies for dealing with calling out and getting out of bed, appropriate instruction giving, ignoring and limit setting, and time out.
Videoconferencing sessions will be conducted in one-on-one format with a therapist (minimum honours level qualification in Psychology) via Microsoft Teams and booked to occur on weeks; 1 (before the first session), week 3 (following the completions of online sessions 1 and 2), week 5 (following the completion of session 3), and week 7 (following the completion of session 4). The first session is a 30 minute orientation session, and all subsequent sessions are 15-minute consultations with a therapist to check on progress, answer any questions, and assist parents with any difficulties they may be having with the strategies or their implementation. The total duration of the intervention is 7 weeks.
The adherence to the intervention will be monitored and assessed by the online module completion and video conference session attendance.
Intervention code [1] 330184 0
Prevention
Intervention code [2] 330185 0
Treatment: Other
Intervention code [3] 330186 0
Behaviour
Comparator / control treatment
Participants will be randomly assigned to either the treatment condition or a wait list control group (WLC). Those who are allocated to the WLC group, will receive no treatment for a period of 3 months (i.e., 12 weeks after pre assessment). After this waiting period and the collection of their post assessment data, they will be provided access to the 4-session online self-help program.
Control group
Active

Outcomes
Primary outcome [1] 340194 0
Child sleep
Assessment method [1] 340194 0
The Child Sleep Habits Questionnaire and the PROMIS Early Childhood Parent Report Scale,
Timepoint [1] 340194 0
Baseline, 12 weeks post assessment.
Primary outcome [2] 340195 0
Child Anxiety
Assessment method [2] 340195 0
the Preschool Anxiety Scale (PAS)
Timepoint [2] 340195 0
Baseline and 12 weeks post assessment.
Primary outcome [3] 340197 0
Child behaviour problems
Assessment method [3] 340197 0
the Child Adjustment and Parent Efficacy Scale (CAPES-44).
Timepoint [3] 340197 0
Baseline and 12 weeks post assessment
Secondary outcome [1] 443231 0
Parental self efficacy
Assessment method [1] 443231 0
The 16-item Me as a Parent Scale
Timepoint [1] 443231 0
Baseline and 12 weeks post assessment
Secondary outcome [2] 443232 0
Parent Mental Health
Assessment method [2] 443232 0
the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [2] 443232 0
Baseline and 12 weeks post assessment
Secondary outcome [3] 443233 0
Parent Sleep
Assessment method [3] 443233 0
The PROMIS adult sleep disturbance scale.
Timepoint [3] 443233 0
Baseline and 12 weeks post assessment
Secondary outcome [4] 443234 0
Treatment satisfaction and acceptability (assessed as a composite secondary outcome)
Assessment method [4] 443234 0
Treatment satisfaction and acceptability will be assessed as a composite outcome at 12 weeks post baseline data collection timepoint in two ways: 1) A 5-item questionnaire adapted from March et al (2008) where parents will be asked to rate their program satisfaction on a 5-point scale. An average scale score will indicate the level of satisfaction with the intervention. 5-item questionnaire: (Q1) Would you tell a friend about this program if their child had sleep problems? Definitely would not (1) to Definitely would (5) (Q2) How helpful was this program in assis9ng you to manage your child’s sleep problem? Very unhelpful (1) to Very helpful (5) (Q3) How happy were you with this program? Very unhappy (1) to Very happy (5) (Q4) Overall, I think this program was... Very bad (1) to Very good (5) (Q5) Is there anything else you’d like to tell us about the program? 2) A 30-minute parent exit interview covering the following: How was your overall experience of participating in Lights Out Online program? Have you noticed any changes in your child’s sleep as a result of the program? (What type of improvements have you seen? What problems still remain or have developed?) How helpful did you find the Lights Out program for your child’s sleep problem? How could we improve the Lights Out Program? How helpful did you find the videoconferencing sessions? What did you like? What didn’t you like? Is there any way we could improve the videoconferencing sessions? e.g., Length - Frequency - Timing - Content
Timepoint [4] 443234 0
12 weeks post baseline
Secondary outcome [5] 443957 0
Treatment engagement
Assessment method [5] 443957 0
Treatment engagement will be measured by the number of sessions completed by participants.
Timepoint [5] 443957 0
12 weeks post baseline

Eligibility
Key inclusion criteria
Participants will be aged 18 years or over and be the parent of a child with sleep difficulties who:
- is aged 3-6 years;
- scores above the clinical cut-off of 41 on the parent-reported Children's Sleep Habits Questionnaire. Parents will be selected as participants based on the presence of their children's sleep problems (not anxiety or behaviour problems).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if their child (i) has an intellectual or a developmental disorder (autism, developmental delay); (ii) is receiving psychological or psychiatric treatment for their sleep problem; (iii) is not stabilised on a medication prior to enrolment into this study or alters their medication dosage during the trial (if the child is using medication for sleep). Parents under the age of 18 years will also be excluded.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
3/02/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318057 0
Charities/Societies/Foundations
Name [1] 318057 0
Australian Rotary Health
Country [1] 318057 0
Australia
Funding source category [2] 318059 0
University
Name [2] 318059 0
Griffith Centre for Mental Health Research
Country [2] 318059 0
Australia
Primary sponsor type
University
Name
Griffith University
Country
Australia
Secondary sponsor category [1] 320412 0
Charities/Societies/Foundations
Name [1] 320412 0
Australian Rotary Health
Country [1] 320412 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316708 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316708 0
Ethics committee country [1] 316708 0
Australia
Date submitted for ethics approval [1] 316708 0
27/10/2023
Approval date [1] 316708 0
05/12/2024
Ethics approval number [1] 316708 0
2023/783

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138742 0
Prof Caroline Donovan
Address 138742 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Country 138742 0
Australia
Phone 138742 0
+61 737353401
Email 138742 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 138743 0
Caroline Donovan
Address 138743 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Country 138743 0
Australia
Phone 138743 0
+61 737353401
Email 138743 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 138744 0
Caroline Donovan
Address 138744 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Country 138744 0
Australia
Phone 138744 0
+61 737353401
Email 138744 0
c.donovan@griffith.edu.au

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:
• This de-identified data may be available to other researchers who hold suitable ethical clearance and wish to collaborate with the investigator team.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified data pertaining to primary and secondary outcomes may be shared. De-identified data will be shared with researchers under circumstances where the researchers have appropriate ethics approvals and appropriate research questions.

What types of analyses could be done with individual participant data?
• The de-identified data may be available for review and meta-analytic purposes or other analyses on request.

When can requests for individual participant data be made (start and end dates)?
From:
Data will only become available after all data has been analysed and results published from the trial. This includes both primary research questions, secondary research questions and those arising from the study later. The start and end dates for when the data will or will not be available are to be determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The data can be obtained from the primary investigator at c.donovan@griffith.edu.au

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form  c.donovan@griffith.edu.au


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.