None listed
Conditions
Brief summary
Anxiety disorders are highly prevalent among children, are often highly comorbid with problematic sleep. These issues are often chronic if left untreated, and lead to numerous problematic consequences. Digital mental health programs increase access to evidence-based interventions and have been shown to be highly effective for numerous mental health problems in youth. However, the online programs developed for child mental health issues to date do not account for comorbidity, and instead focus on only one disorder (e.g., anxiety OR sleep). Children are therefore routinely provided with a digital mental health program targeting their primary presenting problem (i.e., the problem that is causing them the most distress or is most interfering with their functioning). Typically, this means anxiety is routinely treated, but sleep is not. This randomised controlled trial will target children with primary anxiety, who also suffer with a comorbid sleep issue, by comparing an online program targeting BOTH of anxiety and sleep problems, with one that will target ONLY anxiety. We expect that compared to the programs targeting ONLY anxiety, programs directly targeting comorbidity of anxiety and sleep will lead to better and longer-lasting mental health outcomes not only for anxiety problems, but also for comorbid sleep problems.
Interventions
The design involves a two-arm parallel-group RCT where children aged 7-12 years with comorbid anxiety and sleep probelms will be randomly assigned to either the online comorbid (COM) program condition targeting comorbid anxiety and sleep problems, or the online primary diagnosis (PRI) program condition targeting the primary presenting problem of anxiety. Both arms (i.e. Intervention Arm 1 and Intervention Arm 2) will receive an online intervention program.
The online programs will be accessed v
The design involves a two-arm parallel-group RCT where children aged 7-12 years with comorbid anxiety and sleep probelms will be randomly assigned to either the online comorbid (COM) program condition targeting comorbid anxiety and sleep problems, or the online primary diagnosis (PRI) program condition targeting the primary presenting problem of anxiety. Both arms (i.e. Intervention Arm 1 and Intervention Arm 2) will receive an online intervention program. The online programs will be accessed via the Momentum platform (https://momentumhub.org.au). The online interventions on the Momentum platform are self-directed and there is no contact with a therapist or a psychologist. The intervention program will be either 7 (PRI program) or 10 (COM program) sessions. The sessions will become available weekly. Each session does not have to be completed in one go, but each session will need to be completed before the participants move on to the next one. The users will receive automated reminders related to session availability. On the home page, the users will be able to monitor how far they are in their assigned program. The Momentum program sessions have been co-designed with children to ensure they are engaging and interactive. Sessions include the use of images, interactive elements, pop-up messages, and quizzes that provide immediate feedback. Each session comprises approximately 30 slides and takes an estimated 45 minutes to complete. Number of sessions will change depending on the intervention arms. Homework assignments can be completed online or can be printed out. Each session follows a similar format: (1) Feelings check-in (where the young person completes brief anxiety and sleep questionnaires); (2) A review of homework from the previous session; (3) A summary quiz of the previous session; (4) Presentation of the main content of the session (e.g., cognitive restructuring); (5) A quiz to see what they have learned from the session; and (6) Homework activities to be completed over the following week. The sessions will include reminders to children for asking their parents to help them with their sessions and/or homework. Intervention Arm 1: Program targeting comorbidity of anxiety and sleep problems (COM) This program will be provided to those participants with primary anxiety and secondary sleep problems, who have been allocated to the COM arm of the RCT. This COM program involves 10 sessions. The anxiety content of the PRI and COM programs is identical. Session 1 will focus on psychoeducation around anxiety. Sessions 2-4 will focus on anxiety-specific skills (i.e., relaxation, avoidance and exposure). Sessions 5-6 will focus on cognitive restructuring. Session 7 will focus on relapse prevention for anxiety. Sessions 8-9 will focus on sleep problems. Session 10 will focus on reminders of the strategies on anxiety and sleep problems, and a final quiz.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Following registration and the initial assessment process that is part of the open access Momentum Platform, children aged 7-12 years who are found to demonstrate comorbid anxiety and sleep problems will be invited to participate in the RCT. Participants must be willing to participate in either of the two conditions (COM or PRI).
Exclusion criteria
Potential participants will be excluded if the child (i) has an intellectual or a developmental disorder (autism, developmental delay); (ii) is receiving psychological or psychiatric treatment for their identified problems (anxiety or sleep); (iii) is not stabilised on a medication prior to enrolment into this study or alters their medication dosage during the trial (if the participant is using medication for anxiety or sleep).
Outcome results
None listed