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Trial registered on ANZCTR


Registration number
ACTRN12624000631505
Ethics application status
Approved
Date submitted
2/05/2024
Date registered
15/05/2024
Date last updated
15/05/2024
Date data sharing statement initially provided
15/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Setting kids up for life: Evaluating the effectiveness of a digital program for improving the sleep and mental health of children aged 3-12 years
Scientific title
Setting kids up for life: Evaluating the effectiveness of a digital program for improving the sleep and mental health of children aged 3-12 years
Secondary ID [1] 309547 0
Nil known
Universal Trial Number (UTN)
U1111-1291-8948
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Sleep Problems 329835 0
Paediatric Anxiety 329836 0
Paediatric Behaviour Problems 329837 0
Condition category
Condition code
Mental Health 326737 326737 0 0
Other mental health disorders
Mental Health 326738 326738 0 0
Anxiety
Mental Health 326739 326739 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two very similar, but age-appropriate online programs: one for parents of children aged 3-6 years and one for parents of children aged 7-12 years. The Online Treatment Programs (TX) will consist of five online modules aligning with our existing program. All therapy content will be embedded within the program, and modules will be engaging and interactive. The introductory module will focus on psychoeducation and sleep hygiene. The second module will focus on bedtime routines, reward charts, and tips on how best to praise and reward children. The third module will focus on anxiety at bedtime, including exposure, relaxation (and worry at bedtime for the 7-12 year old children). The fourth module will focus on oppositional behaviour at bedtime, including behaviour charts, reward jars, strategies for dealing with calling out and getting out of bed, appropriate instruction giving, ignoring and limit setting, and time out. The final module will focus on tips for parental self-care. The two programs will include the same basic strategies (with the exception of the inclusion of dealing with worry at bedtime and bedtime fading for the 7-12 year olds), but will have age-appropriate examples and methods.

The programs include information, interactive activities, short instructive videos and downloadable resources. Participants will be encouraged to complete the program weekly, however they will continue to have access across the trial period and beyond. The program will time- and date-stamp useage and therefore we will be able to monitor adherence and speed of module completion.
Intervention code [1] 325973 0
Behaviour
Comparator / control treatment
Wait-list control group (wait period will be 12 weeks)
Control group
Active

Outcomes
Primary outcome [1] 334601 0
Paediatric Sleep Problems.

The 33-item Child Sleep Habits Questionnaire [CSHQ] will be used with all parents to assess the frequency of common paediatric sleep difficulties and has been used with children aged 2 to 12 years. A total score greater than 41 has been found to sensitively identify a clinical paediatric sleep disorder and was an inclusion criterion in the present study. The CSHQ has strong psychometric properties.
Timepoint [1] 334601 0
baseline; 12 weeks post-baseline (primary timepoint); 6-months post-baseline
Primary outcome [2] 334602 0
Paediatric Sleep symptoms.

Parents of children aged 3-6 years will complete the 16-item PROMIS Early Childhood Parent Report Sleep Scale [PROMIS-EC:] while parents of children aged 7-12 years will complete the 15-item PROMIS Pediatric Sleep Disturbance Form – Parent Proxy [PROMIS-PP]. Because this study will span across both age versions of the PROMIS, raw scores will be converted to T-scores for analyses. Both scales have well established psychometric properties
Timepoint [2] 334602 0
baseline; 6-weeks post-baseline; 12-weeks post-baseline (primary timepoint); 6-months post-baseline
Secondary outcome [1] 421361 0
Paediatric anxiety.

Parents of children aged 3-6 years will complete the 35-item Preschool Anxiety Scale [PAS], while parents of children aged 7-12 years will complete the 38-item Spence Child Anxiety Scale – Parent Report [SCAS-P]. Because this study will span across both age versions, raw scores will be converted to T-scores for analyses. The PAS and SCAS both have well established psychometric properties.
Timepoint [1] 421361 0
baseline; 12-weeks post-baseline; 6-months post-baseline
Secondary outcome [2] 421362 0
Paediatric Behaviour Problems.

Child Adjustment and Parent Efficacy Scale (CAPES). 27-items rated from 0 (not at all) to 3 (very much)
Timepoint [2] 421362 0
baseline; 12-weeks post-baseline; 6-months post-baseline
Secondary outcome [3] 421363 0
Parental Psychological Distress. Parental psychological distress will be assessed using the 21-item Depression, Anxiety and Stress Scale [DASS-21: 48]. The psychometric properties of the DASS are well-established.
Timepoint [3] 421363 0
baseline; 12-weeks post-baseline; 6-months post-baseline
Secondary outcome [4] 421364 0
Parental sleep problems. Parental sleep problems will be assessed via the 8-item PROMIS Short Form v1.0 – Sleep Disturbance 8a (PROMIS-SD: Yu et al., 2012)
Timepoint [4] 421364 0
baseline; 12-week post-baseline; 6-months post-baseline
Secondary outcome [5] 421365 0
Parental self-efficacy. Parental self-efficacy will be assessed with the 16-item Me as a Parent Scale (Hamilton et al, 2015)
Timepoint [5] 421365 0
baseline; 12-weeks post-baseline; 6-months post-baseline

Eligibility
Key inclusion criteria
Parent or caregiver of a child aged 3-12 years; score on the Child's Sleep Habits Questionnaire has to be 41 or above
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a developmental disorder, receiving any other treatment for their sleep problem, use of medication for sleep that is not stabilised prior to enrolment in the treatment program

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)
allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the inbuilt randomisation tool on the Momentum digital mental health platform on which the program is housed
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
Sample size calculations are based on reducing the percentage of children with clinical level sleep symptoms from 50% (WLC) to 25% (TX) at 6-months. With 80% power (alpha=0.05, two-tailed) we require outcome data on 116 children. To account for 20% attrition we will recruit 146 participants. The between-group difference for the primary outcome will be investigated using a mixed-effects linear regression model. Group (TX/WLC) and timepoint will be included as fixed effects, with a group-by-time interaction. Participants will be included as random effects to account for the repeated measures nature of the data. Secondary outcomes will be calculated using linear, logistic or Poisson models for continuous, binary or count data as appropriate. Analyses will use the intention-to-treat principle. Moderating effects of baseline sleep problem severity will be investigated using moderated regression models

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313739 0
Charities/Societies/Foundations
Name [1] 313739 0
Australian Rotary Health
Country [1] 313739 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Mount Gravatt Campus, Messines Ridge Rd, Mt Gravatt, QLD, 4122
Country
Australia
Secondary sponsor category [1] 315554 0
University
Name [1] 315554 0
University of Southern Queensland
Address [1] 315554 0
UniSQ Springfield Education City, 37 Sinnathamby Blvd, Springfield Central QLD 4300
Country [1] 315554 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312910 0
Griffith University Human Ethics Committe
Ethics committee address [1] 312910 0
Griffith University HREC ,Office for ResearchGriffith University | Nathan | QLD 4111 | Level 0, Bray Centre
Ethics committee country [1] 312910 0
Australia
Date submitted for ethics approval [1] 312910 0
07/02/2023
Approval date [1] 312910 0
24/04/2023
Ethics approval number [1] 312910 0
2023/079

Summary
Brief summary
Sleep problems in children aged 3-12 years are highly prevalent, chronic and are a transdiagnostic risk factor for numerous deleterious mental health, physical health, academic and cognitive outcomes in both the short- and long-term. We have developed a group-based, parent-focused, program for preschool (3-5 years) sleep problems and demonstrated that it not only improves child sleep, but that it also leads to significant improvements in anxiety and behaviour problems, and prevents the later emergence of anxiety. The transdiagnostic impact of our sleep program has the potential to significantly improve the lives of young Australian children and their families. The next step is to make it accessible to as many families as possible by a) extending the program to include children up to 12 years of age with sleep problems and b) digitising the program in order to circumvent barriers to help-seeking.

The aim of the proposed randomized controlled trial is to determine the relative short- and long-term treatment efficacy of an online, parent-focused treatment program (TX) for children with behavioural sleep problems (aged 3-12 years), compared to a Waitlist Control (WLC) condition. The TX condition will be assessed at baseline, post-assessment (6-wks post-baseline), 12-week, and 6-month follow-up. The WLC condition will be assessed at time points corresponding to baseline, post-assessment, and 12-week follow-up, after which they will receive the TX program. Our end goal, if this program is found to be efficacious, is to disseminate the program nationally to all Australian families through our Momentum online digital mental health assessment and treatment platform.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126302 0
Prof Caroline Donovan
Address 126302 0
School of Applied PsychologyMt Gravatt CampusGriffith UniversityM24_2.21 Messines Ridge Rd, Mt Gravatt, QLD 4122
Country 126302 0
Australia
Phone 126302 0
+61 0411611802
Fax 126302 0
Email 126302 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 126303 0
Prof Caroline Donovan
Address 126303 0
School of Applied PsychologyMt Gravatt CampusGriffith UniversityM24_2.21 Messines Ridge Rd, Mt Gravatt, QLD, 4122
Country 126303 0
Australia
Phone 126303 0
+61 0411611802
Fax 126303 0
Email 126303 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 126304 0
Prof Caroline Donovan
Address 126304 0
School of Applied PsychologyMt Gravatt CampusGriffith UniversityM24_2.21 Messines Ridge Rd, Mt Gravatt, QLD,4122
Country 126304 0
Australia
Phone 126304 0
+61 0411611802
Fax 126304 0
Email 126304 0
c.donovan@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data (after de-identification) underlying published results only
When will data be available (start and end dates)?
immediately following publication; no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose deemed appropriate by Primary Sponsor
How or where can data be obtained?
access subject to approvals by Principal Investigator (c.donovan@griffith.edu.au)


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.