RecruitingACTRN12624000631505

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


Sponsor

Griffith University

Enrollment

146 participants

Start Date

Jun 7, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 3 Yearss

Plain Language Summary

Simplified for easier understanding

Sleep problems in children between the ages of 3 and 12 are surprisingly common and can lead to anxiety, behavioural difficulties, and learning challenges. Griffith University has developed a parent-focused program to help children sleep better — and this trial is testing a digital version of that program so families across Australia can access it from home. Parents will be randomly assigned to either start the online program immediately or join a waitlist. The program coaches parents on how to address their child's sleep difficulties, and researchers will track sleep quality, anxiety, and behaviour at several time points over six months. If the program works, it will be made available nationally through an online mental health platform. You may be eligible if you are a parent or caregiver of a child aged 3–12 who scores 41 or above on the Child's Sleep Habits Questionnaire, indicating significant sleep difficulties. Children with a diagnosed developmental disorder or who are already receiving treatment for sleep problems are not eligible. The program is entirely online, making it easy to access from anywhere.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12624000631505