None listed
Conditions
Brief summary
This study is a Randomised Controlled trial (RCT) of an online, schools-based, mental health service called Smooth Sailing. This study will evaluate the effectiveness of Smooth Sailing in comparison to a waitlist control group. Smooth Sailing is a service designed to screen and assess the levels of depression and anxiety among secondary high school students. Using a website, students register to the service and then complete an assessment of their mental health symptoms which consists of brief, clinically validated questionnaires. The service then allocates each student to one of five steps for which different online activities are prescribed. The school counsellor is automatically notified by the service when students are allocated to the highest steps, which indicate the most severe symptoms or if or if they report thoughts that they would be better off dead or harming themselves In some way. The school counsellor then follows up with these students in person. This 12-week trial aims to evaluate the effectiveness of the Smooth Sailing service for improving help-seeking as well as reducing symptoms of depression, anxiety, and distress among secondary school students. It is hypothesised students receiving the Smooth Sailing service will report improved help-seeking, reduced distress, depression, and anxiety, when compared to the waitlist control.
Interventions
Brief Name: Smooth Sailing (Arm 1) Smooth Sailing is an online mental health service designed and administered by the Black Dog Institute. It is based on the principles of stepped care such that the intensity of the recommended interventions is matched to individuals’ symptom severity and individuals will step up if they have not responded to treatment after a set period of time. Smooth Sailing involves: 1. Registration & Baseline Assessment. In class time, participants are given a slip of paper with the service URL and their unique identification code. Using a school or personal internet device, students visit this website and undertake registration. Before registration commences, participants are also asked to complete the Gillick Competency Test. Upon correct completion of this, participants are invited to create a personal profile (name, age, email address, mobile phone number, gender, history of mental health issues, and use of the internet for mental health information). Once a personal profile is created, a series of questionnaires will be used to measure the presence of depression, anxiety, and help-seeking attitudes/ behaviours (see Table 4 in attached protocol for more detail). This will take approximately 30 minutes to complete. 2. Step allocation. Based on the answers inputted during registration, Smooth Sailing allocates each participant to one of five steps. This is automatic and based on a clinical algorithm which accounts for the severity levels of the anxiety and depression symptoms as reported by the participant on the Generalised Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9). Each step matches a severity level and is based on Clinical Practice Guidelines for Adolescent Depression. The step allocations are: Nil/minimal (Step 0), Mild (Step 1), Moderate (Step 2), Moderately Severe (Step 3), and Severe (Step 4). Please see Table 1 in attached protocol for more detail. 3. Delivery of tailored program. After step allocation, Smooth Sailing delivers a program of content that is tailored to each step. Steps 0 and 1 receive online psychoeducation. Step 2 receive online psychoeducation + online self-directed Cognitive Behavioural Therapy (CBT). Steps 3 and 4 receive online psychoeducation + online self-directed CBT + additional support from the School Counsellor. Any participant who is allocated to Step 3 or 4 or reports thoughts that they would be better off dead or harming themselves in some way triggers an electronic notification alert, which is automatically sent to the school counsellor for further investigation. This allows the school counsellor to facilitate a face-to-face session to provide the student with counselling, or them refer on to external services. The online psychoeducation consists of five modules on i) general mental health, ii) depression, iii) anxiety, iv) seeking help for yourself, v) seeking help for a friend. Each of these modules contains information about definitions of mental health terms, signs and symptoms, causes of mental health problems, what to do if needing help, and strategies and tips for what a young person can do immediately. Each module is complemented by animations and illustrations to depict key messages as well as hyperlinks to other credible youth mental health services and websites, including Headspace, Reachout, and Kids Helpline. This content was created specifically for this service, and was reviewed by clinicians. It is designed to be self-directed, such that the youth can read and return to it whenever they wish. The online CBT module consists of a single webpage that outlines two evidence-based self-directed online CBT programs: i) MoodGym (Australian National University) and ii) The BRAVE Program (University of Queensland). MoodGym is an interactive self-help, online program which helps to learn and practise skills for managing symptoms of depression and anxiety. It consists of five modules alongside questionnaires, summaries and a personal workbook. BRAVE was developed for children and teenagers who experience Separation Anxiety Disorder, Social Phobia, Specific Phobia and Generalised Anxiety Disorder. This program helps young people to learn new ways to manage their anxiety and fears. It consists of 10 sessions and is effective for reducing social worries, anxiety about separating from loved ones, fears of specific objects or situation, worries about friendships, school performance or other everyday worries. Please see Table 2 in attached protocol for more detail. 4. Monitoring. At four time points in the study (Day 15, Day 29, Day 57 and Day 71) participants receive an automated 4-item monitoring questionnaire to assess how they are doing. This consists of the PHQ-2 and GAD-2 and will be delivered via email or SMS. Students are then reminded to use the program, with no symptom feedback given. 5. Six-week Reassessment (6-week follow-up): At Day 43, researchers revisit the schools, where participants are asked to log into the service using the same URL and unique ID codes, and are delivered the follow-up questionnaires. The results of these questionnaires are used to determine whether a participant had responded to care or needs to be “stepped up”. In accordance with the Clinical Practice Guidelines for the Treatment of Depression in Young Adults, if a participant has not responded to their care within 6 weeks of their baseline allocation, they would be “stepped up” to the next level of care. See Table 3 in attached protocol for the stepping matrix. The matrix was designed such that a participant would not be stepped down, instead will either remain at the same step or step up. 6. 12-week Reassessment (Post-test/final endpoint): At Day 85, researchers revisit the schools. Participants again log into the service using the same URL and unique ID codes, and are delivered the final endpoint questionnaires. School Counsellors will receive the same types of automated alerts as scheduled in baseline assessment when a student rates their symptoms to be severe or indicative of self-harm or thoughts of dying. Throughout the trial, participating students will use Smooth Sailing at pre-test (for registration and baseline measure collection), at 6-weeks (for reassessment) and at 12-weeks (for final endpoint). Any students who could not access the website at 6-weeks or 12-weeks due to IT issues will be given a paper copy of questionnaires to complete and the research team will input that data electronically into the dataset. Researchers will use a paper scoring method to calculate participants’ step at these timepoints and will inform the school counsellor verbally if the student required follow-up. The online portal will be immediately updated once the research team has entered the data by hand. Service use/ adherence to the intervention will also be measured by analysing the number of online modules accessed by participants, and the number of monitoring questionnaires completed.
Sponsors
Study design
Eligibility
Inclusion criteria
Secondary students will be aged between 11–19 years, and currently attending high school at one of the participating schools. Both males and females will be eligible. As well as including participants that are well, this trial will include adolescents with current depressive symptoms or any adolescents with a history of depression or anxiety. This trial will also include adolescents with current suicidality or a history of suicidality. Participants will be required to have an active email address for the duration of the trial as well as internet access either at home or at school (the school will provide internet access for the duration of the trial). Only those who provide signed written consent will be included. Participating school counsellors are required to be i) working in a participating high school for at least two days per week for the duration of the trial; ii) involved in the service; and iii) have phone and internet access for questionnaire completion and follow-up interview.
Exclusion criteria
Those not willing or able to provide informed consent will be excluded from participating.