Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
313589
0
none
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sleep
336119
0
Query!
Stress
336122
0
Query!
Depression
336120
0
Query!
Anxiety
336121
0
Query!
Condition category
Condition code
Mental Health
332791
332791
0
0
Query!
Anxiety
Query!
Mental Health
332672
332672
0
0
Query!
Other mental health disorders
Query!
Mental Health
332792
332792
0
0
Query!
Depression
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
330186
0
Behaviour
Query!
Intervention code [2]
330185
0
Treatment: Other
Query!
Intervention code [3]
330184
0
Prevention
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
340195
0
Child Anxiety
Query!
Assessment method [1]
340195
0
the Preschool Anxiety Scale (PAS)
Query!
Timepoint [1]
340195
0
Baseline and 12 weeks post assessment.
Query!
Primary outcome [2]
340194
0
Child sleep
Query!
Assessment method [2]
340194
0
The Child Sleep Habits Questionnaire and the PROMIS Early Childhood Parent Report Scale,
Query!
Timepoint [2]
340194
0
Baseline, 12 weeks post assessment.
Query!
Primary outcome [3]
340197
0
Child behaviour problems
Query!
Assessment method [3]
340197
0
the Child Adjustment and Parent Efficacy Scale (CAPES-44).
Query!
Timepoint [3]
340197
0
Baseline and 12 weeks post assessment
Query!
Secondary outcome [1]
443233
0
Parent Sleep
Query!
Assessment method [1]
443233
0
The PROMIS adult sleep disturbance scale.
Query!
Timepoint [1]
443233
0
Baseline and 12 weeks post assessment
Query!
Secondary outcome [2]
443231
0
Parental self efficacy
Query!
Assessment method [2]
443231
0
The 16-item Me as a Parent Scale
Query!
Timepoint [2]
443231
0
Baseline and 12 weeks post assessment
Query!
Secondary outcome [3]
443957
0
Treatment engagement
Query!
Assessment method [3]
443957
0
Treatment engagement will be measured by the number of sessions completed by participants.
Query!
Timepoint [3]
443957
0
12 weeks post baseline
Query!
Secondary outcome [4]
443232
0
Parent Mental Health
Query!
Assessment method [4]
443232
0
the Depression Anxiety and Stress Scale (DASS-21)
Query!
Timepoint [4]
443232
0
Baseline and 12 weeks post assessment
Query!
Secondary outcome [5]
443234
0
Treatment satisfaction and acceptability (assessed as a composite secondary outcome)
Query!
Assessment method [5]
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
Query!
Timepoint [5]
443234
0
12 weeks post baseline
Query!
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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Query!
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)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/08/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
30/11/2025
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
318059
0
University
Query!
Name [1]
318059
0
Griffith Centre for Mental Health Research
Query!
Address [1]
318059
0
Query!
Country [1]
318059
0
Australia
Query!
Funding source category [2]
318057
0
Charities/Societies/Foundations
Query!
Name [2]
318057
0
Australian Rotary Health
Query!
Address [2]
318057
0
Query!
Country [2]
318057
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Griffith University
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320412
0
Charities/Societies/Foundations
Query!
Name [1]
320412
0
Australian Rotary Health
Query!
Address [1]
320412
0
Query!
Country [1]
320412
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316708
0
Griffith University Human Research Ethics Committee
Query!
Ethics committee address [1]
316708
0
https://www.griffith.edu.au/research/research-services/research-ethics-integrity/human/human-research-ethics-committee
Query!
Ethics committee country [1]
316708
0
Australia
Query!
Date submitted for ethics approval [1]
316708
0
27/10/2023
Query!
Approval date [1]
316708
0
05/12/2024
Query!
Ethics approval number [1]
316708
0
2023/783
Query!
Summary
Brief summary
The primary aim of this study is to preliminarily examine the efficacy of a videoconferencing adjunct to Lights Out Online, with respect to improving sleep, anxiety and behavioural outcomes for children, as well as parental self-efficacy, parent mental health and sleep. We expect there to be improvements in each of these areas for both children and parents and also expect parents to report a general level of satisfaction with the program.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
138742
0
Prof Caroline Donovan
Query!
Address
138742
0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
138742
0
Australia
Query!
Phone
138742
0
+61 737353401
Query!
Fax
138742
0
Query!
Email
138742
0
[email protected]
Query!
Contact person for public queries
Name
138743
0
Caroline Donovan
Query!
Address
138743
0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
138743
0
Australia
Query!
Phone
138743
0
+61 737353401
Query!
Fax
138743
0
Query!
Email
138743
0
[email protected]
Query!
Contact person for scientific queries
Name
138744
0
Caroline Donovan
Query!
Address
138744
0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Rd, Mt Gravatt QLD 4122
Query!
Country
138744
0
Australia
Query!
Phone
138744
0
+61 737353401
Query!
Fax
138744
0
Query!
Email
138744
0
[email protected]
Query!
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
[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
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
[email protected]
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.
Download to PDF