The effects of a smartphone cognitive behavioural therapy application on insomnia symptoms in children: a randomised controlled trial and mediation analysis.

Not Applicable

Recruiting

• Conditions: Insomnia symptoms; Depressive symptoms; Anxiety symptoms; Mental Health - Depression; Mental Health - Other mental health disorders; Mental Health - Anxiety

• Registration Number: ACTRN12623000587606
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Children aged 10-12 years, not yet in high school.
Live in Australia.
Have trouble falling asleep or staying asleep during the night.
Own or have access to a smartphone or tablet.
Have internet access, and a parent/guardian with an active email address and mobile phone number.
Have a parent/guardian who can provide consent for participation.
Do not meet diagnostic criteria for previous or current depression

Exclusion Criteria

Meet criteria for current or previous diagnosis of MDD
Fail to satisfy any of the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia symptoms (Child-Reported): The Paediatric Insomnia Severity Index-Adolescent (PISI-A) is a brief child-reported measure of insomnia severity over the past week. It contains 6 items rated on a 0-6 scale, and has good validity and reliability (Byars et al., 2017).[ Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)]