None listed
Conditions
Brief summary
Approximately 7% of 4–17-year-olds experience anxiety disorders. Half of these children do not receive help, and waiting times for seeing psychologists extend beyond 12 months, especially in regional areas. During COVID, 1 in 5 children and adolescents experienced clinical-level anxiety. Studies have demonstrated that increasing access to internet-based Cognitive Behavioural Therapy (iCBT) for anxiety can assist with this growing health concern. However, there have been challenges in identifying an optimum digital model of care for effectively addressing anxiety in children and adolescents who reside in regional areas. Studies in iCBT suggest that while some level of therapist support is necessary to enhance motivation, address diagnostic complexity, and personalize treatment for effectively alleviating severe anxiety, it is crucial for treatment to be delivered remotely, at scale, with minimal cost, and without the long waiting times currently experienced with face-to-face services in regional areas. There is a need to develop a new digital model of care that can bridge the gap between self-help and therapist-assisted approaches, effectively reducing anxiety among children and adolescents, and be suitable for dissemination in regional areas. This project will test a new evidence-informed digital model of care for child and adolescent anxiety that combines standard, self-help iCBT program with minimal therapist support at crucial treatment stages and weekly messaging support. To date, no studies have tested such digital model of care for children and adolescent in regional areas. If this model, using self-help iCBT with minimal therapist support is more effective than self-help iCBT alone, we will have identified a scalable, easily disseminated model that is effective for alleviating anxiety among children and adolescents in regional areas. In this project, therapists will offer minimal support (2 x 30 mins sessions at pre- and mid-treatment) via telephone or video conferencing. Additionally, they will send weekly messages to young people, which can be accessed at any location and time. Therefore, this model of care can be readily disseminated and is non-intrusive to young people.
Interventions
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
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 receive automated email reminders of session availability, reminding of overdue sessions and reinforcing progress. In addition to the online program, participants will have consultations with a Momentum Coach via videoconferencing or teleconferencing - depending on availability at location and client preferences. A Momentum Coach will conduct two 30 minute individual consultation sessions via video/teleconferencing with the child and their parent. The first Momentum Coach consultation will be conducted prior to participants commencing session 1 of their Momentum program. The aim of the consultation will be to establish rapport, set expectations, identify goals and explain the program. A Momentum Coach will provide the second consultation with the participant after the completion of session 3 of their Momentum program (treatment mid-point and at a critical exposure hierarchy point) to provide clarification of techniques and to assist understanding and implementation of the exposure hierarchy. Each consultation session will be completed with parents and children at a convenient time. The participants in the iCBT plus group will also receive two types of additional messaging support over 7 weeks for the duration of the program. The first messaging support will be in the form of one weekly message from a Momentum Coach. Momentum Coaches will review user responses in the Momentum session material and curate a message (email within platform) based on templates to provide assistance to the young person. Messages will be personalised by the Coach (based on their responses to session activities and homework) and aim to reinforce effort, redirect incorrect responses and set additinoal practice tasks. The weekly messages will be delivered via the internal Momentum program message system and can only be viewed when logged into the program. The second type of messaging support will be two weekly coach tips focused on the implementation of anxiety strategies (skills tips) and completion of homework activities (practice reminders) sent via SMS (or email if preferred). These messages will assist with real-time implementation of skills. These messages have been designed by the research team based on results from previous trials, and qualitative research with young people, parents and clinicians previously using our programs. The messages aim to complement the skills that will be being learnt/practised during that session. The coach tips will be sent out to prompt skill rehearsal; one message will be sent 1-day after session completion and one message sent 4 days after session completion, each week unitl the end of the program. In terms of treatment fidelity, therapists are required to keep a record of the number of minutes spent each week on viewing responses and sending emails, to provide a check of the treatment provided. Further, a random sample of 10% of email responses will be examined by the lead investigator to check adherence to template email responses. Participants will be able to access the online program beyond the 12-week assessment, although no therapist support will be provided beyond this point. Session completion will be tracked at each time point.
Sponsors
University of Southern Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to 17 Years
Healthy volunteers
No
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 interview): (1) a primary diagnosis of social anxiety disorder (SAD), generalised anxiety disorder (GAD), separation anxiety (SEP), or specific phobia (SP) on the Anxiety Disorders Interview Schedule for Children – Child and Parent version (ADIS-C/P; Silverman and Albano, 1996); (2) willingness to be randomised to one of the two conditions. Children and adolescents with a primary diagnosis of obsessive-compulsive disorder (OCD), posttraumatic disorder (PTSD) or panic disorder (PD) will not be eligible for participation. However, these diagnoses will be permitted if secondary. Participants with secondary mood disorders will be included, provided that their mood disturbance had a clinician severity rating (CSR) of <5 on the ADIS-C/P.
Exclusion criteria
Children and adolescents with current suicidal ideation, self-harm tendencies, substance abuse issues, significant behavioural disorders, pervasive developmental disorders, learning disorders, or those currently receiving professional help, as well as those who initiated or altered medication for anxiety or sleep within the six weeks leading up to the baseline assessment, will be excluded from the study.
Outcome results
None listed