Finding the right balance of ‘support’: Testing a new digital model of care for child and adolescent anxiety in regional communities

INTERVENTION: There are two intervention conditions in this study: (1) standard self‐help internet‐based cognitive‐behaviour therapy + brief coaching and messaging support (iCBT Plus) and (2) standard self‐help internet‐based cognitive‐behaviour therapy (iCBT‐Std) Intervention Arm 1‐ iCBT Plus Participants in this condition will receive a standard self‐help iCBT program for anxiety + brief coaching and messaging support. The standard self‐help iCBT program will be delivered via the Momentum platform, which is an up‐to‐date web platform adapted from existing iCBT web platforms, to provide evidence‐informed, scalable and openly accessible iCBT programs. The standard self‐help iCBT program is comprised of 7 online sessions of approximately 45‐minute duration, completed once per week. The Momentum anxiety program includes evidence‐based anxiety management strategies such as recognition of physiological symptoms, relaxation, coping self‐talk, cognitive restructuring, graded exposure, and self‐reinforcement. Sessions comprise visually appealing pages, reading material, question/answer exercises, games, quizzes and homework. Young people will be given 1‐2 homework tasks per week that will take approximately 15‐30 minutes to complete. Homework tasks will include the following: recording anxiety‐provoking situations, practising relaxation techniques, identifying avoidance, working on graded exposure exercises, and engaging in cognitive restructuring exercises. Homework will be assigned for each of the 7 sessions, and SMS reminders will refer to these tasks (see below). There are different versions of the program for children (aged 7‐12 years) and adolescents (aged 13‐17 years). Young people progress through sessions at the rate of one session per week. Participants recei CONDITION: Anxiety disorders; ; Anxiety disorders Mental Health ‐ Anxiety PRIMARY OUTCOME: The primary outcome is the clinician severity rating relating to the primary anxiety disorder, at 9‐months after the start of treatment.[Clinician rating of symptom severity for the primary anxiety diagnosis will be determined from information obtained in the diagnostic interview, and rated on a 0‐8‐point scale. The 0‐8 point scale is a standardised scale, part of the Anxiety Disorders Interview Schedule (Clinician Severity Rating Scale). ; ; Diagnostic severity will be determined via a "blind", independent clinical diagnostic interview for anxiety disorders and clinician severity rating of diagnosis using Anxiety Disorders Interview Schedule: Child and Parent versions (ADIS‐C/P). A composite diagnosis and associated clinician severity ratings (0‐8 point) will be produced following the standardised procedure of ADIS‐C/P. 9 months after the start of treatment (primary endpoint); Data also gathered at:; Pre‐treatment; 12 weeks after the start of treatment; ] SECONDARY OUTCOME: Children's Anxiety Scale‐8 (CAS‐8)[THe CAS‐8 is a brief 8‐item anxiety scale to assess total anxiety severity. This measure is completed as a standard part of the online program at the beginning of each session, to measure changes in anxiety symptoms.] Children's global functioning will be measured by the Children's Global Assessment Scale (CGAS) ‐ clinician rated based on data obtained in the ADIS‐C&P[The CGAS provides a single global rating of functioning, assigned to the youth by the independent, interviewing clinician, on a scale of 0 to 100, where lower scores indicate poorer functioning. A rating is given based on the child or adolescent's most impaired level of general functioning for the specified time period by selecting the lowest level which describes his/her functioning on a hypothetical continuum of health‐illness, benchmarked against anchor points in a descriptive glossary. This assessment will be based on information obtained in the diagnostic interview with children and parents. Pre‐treatment ; 12 weeks after the pre‐treatment ; 9 months after the pre‐treatment] Diagnostic status: free of all anxiety disorders[In this outcome, diagnostic status will be defined as whether or not the participant is free of all anxiety disorders. ; ; Diagnostic status will be determined via a "blind", independent clinical diagnostic interview for anxiety disorders and clinician severity rating of diagnosis using Anxiety Disorders Interview Schedule: Child and Parent versions (ADIS‐C/P). Pre‐treatment ; 12 weeks after the pre‐treatment ; 9 months after the pre‐treatment] Diagnostic status: free of primary anxiety disorder.[In this outcome, diagnostic status will be defined as whether or not the participant is free of their primary anxiety disorder. ; ; Diagnostic status will be determined via a "blind", independent clinical diagnostic interview for anxiety disorders and clinician severity rating of diagnosis using Anxiety Disorders Interview Schedule: Child and Parent versions (ADIS‐C/P). Pre‐treatment ; 12 weeks after the start of treatment ; 9 months after the start of treatment] Health‐related Quality of life will be measured by the Child Health Utility 9 Inde X(CHU9D) ; [The CHU9D is a paediatric generic preference‐based measure of health‐related quality of life suitable for 7‐ to 17‐year‐olds. The CHU9D consists of 9 items. This measure assesses nine domains of general health in children, including: Worried, Sad, Pain, Tired, Annoyed, School Work, Sleep, Daily Routine, and Activities and will be used to assess quality of life. Pre‐treatment ; 12 weeks after the start of treatment ; 9 months after the start of treatment] Spence Children's Anxiety Scale‐ Child and Parent Version (SCAS‐C&P)[This measure will be completed by parents and children and provides a comprehensive anxiety symptom assessment. The total anxiety score will be used as a secondary outcome measure. Participants with elevated pre‐treatment scores (completed at program registration) will be invited to complete the diagnostic interview. Pre‐treatment ; 12 weeks after the start of treatment ; 9 months after the start of treatment] The Child Anxiety Life Interference Scale (The CALIS)[The CALIS is a measure of anxiety‐related life interference in children that is comprised of 9 items rated by children and 16 items rated by parents. Pre‐treatment ; 12 weeks after the start of treatment ; 9 months after the start of treatment] Treatment adherence ‐ number of sessions completed[This data will be automatically generated through the program and will include the number of prescribed sessions and activities completed throughout the program. 12 weeks after the start of treatment ; 9 months after the start of treatment] Treatment expectancy by children and parents[Treatment expectancy will be assessed at the end of session 1 through a 5‐item questionnaire developed by the team in earlier studies (March et al. 2009; Spence et al. 2006). At end of session 1 of the intervention.] Treatment Satisfaction scale ‐ child and parent satisfaction with treatment. [Treatment satisfaction will be assessed after 12 weeks of starting the treatment with a 5‐item questionnaire developed by the team in earlier studies (March et al. 2018). Satisfaction will also be measured half‐way through treatment, at the end of session 3. After session 3 ; 12 weeks after the start of treatment] INCLUSION CRITERIA: Children and adolescents will be invited to participate in the study if they meet the following criteria at initial registration for the Momentum platform; (1) if they present with elevated levels of anxiety on the Spence Children’s Anxiety Scale (equal or greater than 84th percentile or T‐score of 60); (2) are residents of regional/rural areas (as classified by areas 2‐7 of the Modified Monash Model, identified via postcode); (3) do not demonstrate clinically interfering depression levels on the Centre for Epidemiological Studies Depression Scale for Children. Clinically interfering levels are defined as meeting the 'elevated' cut‐off on this scale AND rating the degree of interference from the depression at a minimum of 5 or higher on an 8‐point scale; (4) have access to the Momentum online platform via a computer or mobile device with an Australian IP address; (5) aged 7‐17 years; Additional inclusion criteria (ascertained via intervi