Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000587606
Ethics application status
Approved
Date submitted
4/05/2023
Date registered
30/05/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
30/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a smartphone cognitive behavioural therapy application on insomnia symptoms in children: a randomised controlled trial and mediation analysis.
Scientific title
The effects of a smartphone cognitive behavioural therapy application, Sleep Ninja, on insomnia symptoms in children: a randomised controlled trial and mediation analysis.
Secondary ID [1] 309555 0
NA
Universal Trial Number (UTN)
U1111-1294-4167
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia symptoms
329845 0
Depressive symptoms 330104 0
Anxiety symptoms 330105 0
Condition category
Condition code
Mental Health 326753 326753 0 0
Depression
Mental Health 326755 326755 0 0
Other mental health disorders
Mental Health 326756 326756 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial Arm 1. Intervention group: Sleep Ninja is an automated smartphone app co-designed with 12-16-year-olds and parents to deliver CBT-I. It is free and publicly available for devices using iOS and Android operating systems. Given its gamified features and content reading level (Years 5-6), Sleep Ninja is suitable for 10–12-year-olds. Sleep Ninja has been further adapted to a younger age group with parent input to involve parents in the intervention. The program includes 6 modules (referred to as ‘training sessions’), a sleep tracking function, sleep scheduling based on required wake time, personalised wind-down routine and reminders, a series of sleep tips, sleep meditation and general information about sleep. The app uses gaming elements to enhance engagement, based on a Ninja analogy. Users complete training sessions to increase their sleep skills, allowing them to “level up” (move to the next level), and finish the program with a black belt in sleep. Each training session takes approximately 5-10-mins to complete and covers a core CBT-I strategy delivered through an automated chat-bot where the Ninja acts as a sleep coach. Components include sleep scheduling and circadian rhythms (training 1), stimulus control (training 2), daytime functioning and the pre-bed routine (training 3), cognitive therapy to address worries at night (training 4), planning for high-risk situations (training 5), and a final review session (training 6). Users progress through the app by completing each training session and tracking their sleep for 3 nights (out of a 7-night period). Interaction with other functions within the app (e.g., bedtime mediation, sleep tips, general sleep information) are at the users discretion. The use of Sleep Ninja is self-guided, allowing the user to choose the duration and frequency of use, however, it is recommended users complete at least one training session per week. Sleep Ninja is designed to be used during the day and not at bedtime to prevent screen time and blue light interference with sleep.

Integration of parents in the intervention includes encouraging and assisting their child to complete the training sessions and sleep tracking, and supporting their child to implement the CBT-I strategies learnt during the sessions (e.g., implementing the Sleep Ninja recommended sleep routine, implementing the pre-bed winddown, removing sleep deterrents (devices) from the bedroom, managing unhelpful beliefs about sleep).

During the trial, use of Sleep Ninja will be restricted to 6-weeks for participants in Trial Arm 1, however, on completion of the trial participants will have unlimited access to Sleep Ninja. Adherence to the intervention will be measured using the Treatment Adherence and Satisfaction Questionnaire.
Intervention code [1] 325980 0
Treatment: Other
Comparator / control treatment
Trial Arm 2. Active control: This study will utilise an active control condition. Participants allocated to this condition will receive 6 weekly psychoeducation flyers designed specifically for this study and optimised for viewing on mobile devices. The psychoeducation flyers are matched for visual appeal and engagement duration, taking 5- to 10-mins to complete. They consist of 6 topics: 1) Why do we sleep?, 2) Fun facts about sleep, 3) Tips to help you sleep – part 1, 4) Tips to help you sleep – part 2, 5) Stress and sleep, 6) Where to go for more help. Participants in this condition will receive, and have unlimited access to, the Sleep Ninja app after the tertiary endpoint at 9-months post-baseline.

Control group
Active

Outcomes
Primary outcome [1] 335936 0
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] 335936 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [1] 421416 0
Depressive Symptoms (Child-Reported)

The Revised Child Anxiety and Depression Scale - 25 (RCADS-25); Depression subscale; Child Report; contains a 10 item parent questionnaire that measures symptoms of depression in children and adolescents aged 8 – 18. The child self-report version has good psychometric properties in 8-18 year-olds (Ebesutani et al., 2017).
Timepoint [1] 421416 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [2] 421421 0
Major Depressive Disorder diagnosis will be assessed using the web-based Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-COMP; assessment of mood disorders only) (Kaufman et al., 1997) is an extensively used tool to assess DSM-V diagnostic criteria. The K-SADS-COMP has demonstrated reliability, and validity in the assessment of childhood psychiatric diagnoses (Kaufman et al., 1997).
Timepoint [2] 421421 0
Timepoint 1: Baseline (Week 0) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [3] 421422 0
Anxiety Symptoms (Parent-Reported) The Revised Child Anxiety and Depression Scale - 25 (RCADS-25) is a 25-item scale that measures symptoms of depression and anxiety in children and adolescents aged 8 – 18. The anxiety subscale includes 15 items that assess anxiety symptoms as rated by the parent. The parent version has good psychometric properties in 8-18 year-olds (Ebesutani et al., 2017).
Timepoint [3] 421422 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [4] 421423 0
Anxiety Symptoms (Child-Reported) The Revised Child Anxiety and Depression Scale - 25 (RCADS-25) is a 25-item scale that measures levels of depression and anxiety in children and adolescents aged 8 – 18. The anxiety subscale includes 15 items that assess anxiety symptoms as rated by the child. The child self-report version has good psychometric properties in 8-18 year-olds (Ebesutani et al., 2017).
Timepoint [4] 421423 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [5] 421424 0
Previous use of mobile apps for sleep. Participants will be asked whether they have ever used a mobile app to improve their sleep, and how much they think their sleep could be improved by using a sleep smartphone app.
Timepoint [5] 421424 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [6] 421550 0
Repetitive negative thinking: The Persistent and Intrusive Negative Thoughts Scale (PINTS; Magson et al., 2019) is a 5-item questionnaire that assesses the frequency and intensity of negative thoughts that may contribute to emotional distress in children, adolescents and adults. The PINTS has demonstrated good internal consistency and reliability in children (Magson et al., 2019).
Timepoint [6] 421550 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [7] 421551 0
Dysfunctional Beliefs and Attitudes about Sleep

The Dysfunctional Beliefs and Attitudes about Sleep (DBAS) measures dysfunctional beliefs about sleep, on a Likert scale from 1 - Strongly Disagree to 5 – Strongly agree (Gregory et al., 2009). The DBAS-C10 has been adapted for use with children and has demonstrated validity and reliability (Blunden et al., 2013).
Timepoint [7] 421551 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [8] 421552 0
Sleepiness: The Epworth Sleepiness Scale (ESS) for children and adolescents is a short questionnaire designed to assess daytime sleepiness in eight different situations, and a modified version has been designed for children (Paruthi, 2022). Respondents are asked to rate on a 4-point scale (0 to 3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS total score can range from 0 to 24. The higher the ESS score, the higher that person’s average sleep propensity in daily life, or their ‘daytime sleepiness’. The ESS has demonstrated high internal reliability (Janssen et al., 2017).
Timepoint [8] 421552 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [9] 421944 0
Treatment Adherence and Satisfaction
Timepoint [9] 421944 0
Timepoint 2: Primary endpoint (Week 6)
Secondary outcome [10] 426189 0
Pre-sleep arousal: The Sleep Anticipatory Anxiety Scale – Adolescent Version (SAAQ; Bootzin et al., 1994) measures anxiety levels before going to bed or during the pre-sleep period. The SAAQ assesses the intensity of anxiety symptoms related to sleep, including worry, restlessness, and anticipatory thoughts via three subscales: Somatic, Sleep-related cognitions and Rehearsal/planning. The scale measures the degree of anxiety individuals may experience in relation to sleep and is widely used in youth samples and demonstrated validity and reliability (Hiller et al., 2014).
Timepoint [10] 426189 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [11] 426190 0
Sleep quality: measured using a single item adapted from the sleep quality question in the Pittsburgh Sleep Quality Index.
Timepoint [11] 426190 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [12] 426191 0
Insomnia symptoms (Parent-Reported) The Paediatric Insomnia Severity Index (PISI) is a brief parent-reported measure of insomnia severity over the past week. It contains 6-items rated on a 0-6 point scale and has good validity and reliability in children aged 4-10 years (Byars et al., 2017).
Timepoint [12] 426191 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [13] 426192 0
Depressive Symptoms (Parent-Reported) The Revised Child Anxiety and Depression Scale - 25 (RCADS-25); Depression subscale; Parent Report; contains an 11-item parent questionnaire that measures symptoms of depression children and adolescents aged 8 – 18. The parent version has good psychometric properties in 8-18 year-olds (Ebesutani et al., 2017).
Timepoint [13] 426192 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6) Timepoint 3: Secondary endpoint (Week 12) Timepoint 4: Tertiary endpoint (Week 36)
Secondary outcome [14] 426193 0
Child and adolescent quality of life. The Child Health Utility 9D (CHU-9D; Stevens, 2009) is a 9-item scale designed to measure child and adolescent quality of life. The measure covers nine domains of adolescent functioning including worry, sadness, pain, tiredness, annoyance, schoolwork/homework, sleep, daily routine, and ability to join activities. Each domain is rated on a 5-point scale. The scale has demonstrated good practicality, face, and construct validity (Ratcliffe et al., 2011; Ratcliffe et al., 2012; Stevens & Ratcliffe, 2012).
Timepoint [14] 426193 0
Timepoint 1: Baseline (Week 0) Timepoint 2: Primary endpoint (Week 6)

Eligibility
Key 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
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Meet criteria for current or previous diagnosis of MDD
Fail to satisfy any of the inclusion criteria

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)
Eligibility for the study will be determined by a self-report online questionnaire completed on the Qualtrics survey platform. Randomisation to one of the two trial arms will occur following completion of the K-SADS interview using a computerised randomisation procedure within the Qualtrics survey platform. No research personnel will be involved in the randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out according to the International Council for Harmonisation (ICH) guidelines (Lewis, 1999). Randomisation to one of the two trial arms will occur following completion of the K-SADS interview using a computerised randomisation procedure within the Qualtrics survey platform. Randomisation will be stratified according to three strata of gender (male/female/gender diverse), with ‘gender diverse’ including participants that select Non-binary or Different identity as their gender identity. Allocation will be fully automated, with no interference from the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Blinding - Participants: All study materials will refer to the interventions being examined as “activities to improve sleep” to conceal Sleep Ninja being the smartphone app used in the trial. This is to prevent participants allocated to the control condition from accessing the Sleep Ninja smartphone app, which is publicly and freely available for download, during their participation in the trial. While participants will be aware of which activity or information they will be required to use (due to the PICF and instructions for use provided), They will not be directly informed of their condition allocation (i.e., intervention vs. control) to prevent biases in reporting related to expectancies.

Blinding – Statistician: The statistician involved in examining the effects of the conditions of primary and secondary outcomes will not be informed of participants’ specific intervention allocation. Condition allocated will be marked as “Condition A, Condition B” to ensure the statistician remains blinded to participants’ intervention upon primary and secondary analysis of the results. All other potential markers of allocation will be removed from the data analysis file. Upon completion of these analyses, the statistician will be become unblinded when examining mediators and moderators as well as intervention completion rates. This data will only be reviewed by the trial statistician upon completion of the primary and secondary outcomes.

Blinding – Chief Investigators, Trial Managers, Data Analyst and Research Officers/Assistants: The chief investigators, trial manager and research assistants will be unblinded to participants’ allocation as they will have access to the Qualtrics data to contact participants if they experience adverse events. They will also be responsible for downloading and cleaning the data extracted and administering the KSADS. The Chief Investigators, Trial Managers, Data Analyst and Research Officers/Assistants will not be involved in data analysis of the primary and secondary outcomes.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted to determine the effect of the intervention on insomnia symptoms at the primary, and secondary endpoints. Analyses will be undertaken on an intent-to-treat basis, including all randomised participants, regardless of intervention received. For scaled outcomes, mixed-model repeated measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data. The primary hypothesis will be evaluated by a contrast evaluating change in child-reported insomnia symptoms between baseline and the post-intervention assessment point (primary endpoint), based on the interaction between time and condition. The same approach will be used for secondary outcomes. Exploratory analyses will compare proportion of young people who meet criteria for MDD at the tertiary endpoint, as well as those showing significant symptoms of depression (operationalised as a t-score of greater than 65 on the RCADS). Mediation analyses addressing whether improvements in depression are mediated by changes in sleep, and the potential contribution of cognitive processes will be conduction using an additional MMRM analyses. Other outcomes (i.e, adherence and acceptability) will be described.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2023
Actual
Date of last participant enrolment
Anticipated
16/12/2024
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
214
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313747 0
Charities/Societies/Foundations
Name [1] 313747 0
Australian Rotary Health
Country [1] 313747 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 315577 0
None
Name [1] 315577 0
NA
Address [1] 315577 0
NA
Country [1] 315577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312918 0
University of New South Wales Human Research Ethics Commitee
Ethics committee address [1] 312918 0
UNSW Research Ethics and Compliance Support
The University of New South Wales
Sydney
NSW 2052
Ethics committee country [1] 312918 0
Australia
Date submitted for ethics approval [1] 312918 0
14/02/2023
Approval date [1] 312918 0
24/04/2023
Ethics approval number [1] 312918 0
HC230070

Summary
Brief summary
This clinical trial aims to investigate the effectiveness of a Cognitive Behavioural Therapy for Insomnia (CBT-I) program delivered via a smartphone application (called Sleep Ninja®) for improving sleep and mental health outcomes in Australian children (aged 10 to 11 years) with disrupted sleep relative to an active control.

A. Primary Aim: To determine whether the Sleep Ninja app reduces insomnia symptoms at post-intervention compared to an active control.

B. Secondary Aims: To determine the effects of the Sleep Ninja on depression, anxiety, sleep quality and daytime sleepiness compared to an active control.

C. Subsidiary and Exploratory Aims: To examine whether the reduction in depressive symptoms is mediated by changes in sleep, and to explore the possible mediating role of cognitive processes including repetitive thinking, dysfunctional beliefs about sleep and pre-sleep arousal. To explore the emergence of new cases of MDD at the tertiary endpoint.

Hypotheses:

Participants receiving the Sleep Ninja app, relative to the active control will report:

A1: Improved insomnia symptoms at post-intervention (primary endpoint).
B1: Improvement in depression and anxiety, daytime sleepiness and sleep quality at post-intervention.
C1: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms.
C2: In the Sleep Ninja condition, reductions in depressive symptoms will be mediated by improvements in insomnia symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126330 0
Dr Sophie Li
Address 126330 0
Black Dog Institute, The University of New South Wales, Sydney, NSW, 2031
Country 126330 0
Australia
Phone 126330 0
+61 2 9382 4544
Fax 126330 0
Email 126330 0
s.h.li@blackdog.org.au
Contact person for public queries
Name 126331 0
Dr Sophie Li
Address 126331 0
Black Dog Institute, The University of New South Wales, Sydney, NSW, 2031
Country 126331 0
Australia
Phone 126331 0
+61 2 9382 4544
Fax 126331 0
Email 126331 0
s.h.li@blackdog.org.au
Contact person for scientific queries
Name 126332 0
Dr Sophie Li
Address 126332 0
Black Dog Institute, The University of New South Wales, Sydney, NSW, 2031
Country 126332 0
Australia
Phone 126332 0
+61 2 9382 4544
Fax 126332 0
Email 126332 0
s.h.li@blackdog.org.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?
The individual participant data of those who consented to have their data published in a deidentified data set during trial registration will be available for sharing, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal with ethics approval will be reviewed on a case-by-case basis, and data shared at the discretion of the Prinicpal Investigator.
Available for what types of analyses?
The data will not be made available for any specific type of analysis, and instead will be considered on a case-by-case basis in line with the research question being proposed.
How or where can data be obtained?
Access to the data can be obtained by emailing the research team on childsleep@blackdog.org.au, subject to approval by Principal Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19029Study protocol  childsleep@blackdog.org.au 385818-(Uploaded-20-08-2023-21-29-37)-Study-related document.pdf
19030Informed consent form  childsleep@blackdog.org.au 385818-(Uploaded-20-08-2023-21-39-17)-Study-related document.pdf
19032Ethical approval    385818-(Uploaded-01-05-2023-15-05-45)-Study-related document.Pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised controlled trial evaluating the effect of a CBT-I smartphone application (Sleep Ninja) on insomnia symptoms in children.2023https://dx.doi.org/10.1186/s12888-023-05185-x
N.B. These documents automatically identified may not have been verified by the study sponsor.