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

INTERVENTION: 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 CONDITION: Insomnia symptoms ;Depressive symptoms ;Anxiety symptoms; ; Insomnia symptoms ; ; Depressive symptoms ; Anxiety symptoms Mental Health ‐ Anxiety Mental Health ‐ Depression Mental Health ‐ Other mental health disorders SECONDARY OUTCOME: Anxiety Symptoms (Child‐Reported) ; ; The Revised Child Anxiety and Depression Scale ‐ 25 (RCADS‐25); Anxiety subscale; Child Report contains a 6‐item child self‐report questionnaire that measures symptoms of anxiety 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: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Anxiety Symptoms (Parent‐Reported) ; ; The Revised Child Anxiety and Depression Scale ‐ 25 (RCADS‐25); Anxiety subscale; Parent Report contains a 7 item parent questionnaire 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 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] 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: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] 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 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Emotion Regulation ; ; The Emotion regulation questionnaire for children and adolescents (ERQ) is a 10 item self‐report measure that assess levels of cognitive reappraisal and emotional suppression on a 0‐7 Likert scale (Gross & John, 2003). The ERQ‐CA has been adapted for use with children and has demonstrated appropriate validity and reliability (Gullone & Taffe, 2012). [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Insomnia symptoms (Child‐Reported) ; ; The Paediatric Insomnia Severity Inde X‐ adolescent (PISI‐A) is a valid and reliable self‐report measure of insomnia severity adapted from the PISI ‐ parent version for children aged 11‐18 years (Lebourgeois et al., 2005).[Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Major Depressive Disorder diagnosis ; ; The Kiddie Schedule for Affective Disorders and Schizophrenia (K‐SADS; assessment of mood disorders only) is an extensively used tool to assess DSM‐V diagnostic criteria. The K‐SADS has demonstrated reliability, and validity in the assessment of childhood psychiatric diagnoses (Kaufman et al., 1997). The mood module will be administered.[Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)Timepoint 1: Baseline (Week 1) ; ] Perseverative Thinking ; ; The Perseverative Thinking Questionnaire—Child Version (PTQ‐C) contains 15 items on a 5‐point Likert scale and assesses repetitive negative thinking. The PTQ‐C has demonstrated excellent validity and reliability with children (Bijttebier et al., 2015) [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Previous use of mobile apps for mental health ; ; Participants will be asked whether they have ever used a mobile app for their emotional wellbeing or mental health, and if so, whether they found it helpful. Participants will also be asked how much they think their emotional wellbeing could be improved by using a mental health smartphone app. [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Rumination ; ; The Children's Response Style Questionnaire, Rumination Subscale ; ; The rumination subscale of the Children's Response Style Questionnaire is a child‐appropriate adaptation of the original Ruminative Response Scale (Nolen‐Hoeksema et al., 1999). This subscale has demonstrated validity in youth, and cross‐cultural samples (Lo et al., 2017). [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Sleep Parameters ; ; 7 day sleep diary – Participants record daily sleep schedules (bedtime and rise time) and subjective sleep impressions (sleep onset latency, number of awakenings and time spent awake during the night) with the assistance of their parents. Sleep/wake diaries have been widely used to document outcomes in child insomnia treatment studies (Paine & Gradisar, 2011), and provide reliable and valid information about the subjective experience of insomnia (Morin, 2003), and correlate well with objective sleep measures (i.e., actigraphy) in children (Giana et al., 2004). [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Sleepiness ; ; The Children's Report of Sleep Patterns–Sleepiness Scale (CRSP‐S) has 5 items that ask children to recall how often they felt sleepy or fell asleep in different situations (at school, during short car rides, while playing, while eating, and while talking) (Meltzer, 2016) [Timepoint 1: Baseline (Week 1) ; Timepoint 2: Primary endpoint (Week 6) ; Timepoint 3: Secondary endpoint (Week 24) ; Timepoint 4: Tertiary endpoint (Week 52)] Treatment Adherence and Satisfaction[Timepoint 2: Primary endpoint (Week 6)] 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 PRIMARY OUTCOME: 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 1: Baseline (Week 1); Timepoint 2: Primary endpoint (Week 6); Timepoint 3: Secondary endpoint (Week 24); Timepoint 4: Tertiary endpoint (Week 52)] 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 1: Baseline (Week 1); Timepoint 2: Primary endpoint (Week 6); Timepoint 3: Secondary endpoint (Week 24); Timepoint 4: Tertiary endpoint (Week 52)]