None listed
Conditions
Brief summary
This pilot study is testing a new support service called "While We Wait", designed specifically for adolescents aged 14 to 17 years who are waiting for mental health treatment as referred by their General Practitioner (GP). The study will explore whether this new service is practical to deliver, whether young people, their families, and GPs find it helpful and easy to use, and whether it provides any early psychological benefits or causes any problems. The research team will focus on the feasibility and acceptability, preliminary benefits to mental health, as well as the safety of the intervention.
Interventions
This pilot clinical trial aims to investigate the feasibility, acceptability, and preliminary benefits and safety of a new service model (called While We Wait) for addressing the psychological needs of Australian adolescents (aged 14 to 17 years) during the wait time for mental health treatment as referred by their General Practitioner (GP). The interventions administered throughout the study are as follows: For GPs: • GP online training module and pre-service (i.e., baseline) procedures: After expressing their interest in the study by responding to the study advertisements in the GP recruitment period (up to 3 months), GPs who satisfy the inclusion criteria will be contacted by the research team (by email and/or telephone) and provided copies of the study information (including the GP Participant Information Sheet and Consent Form, the Adolescent Participant Information and Consent Form, and a sample copy of the GP Report). At this time, GPs will be invited to complete a one-hour live or pre-recorded webinar (dependent on their scheduling) that offers information on how to support adolescent patients on the waitlist for psychological treatment. This will be delivered by co-investigator who is a GP, training facilitator, and primary care academic. The webinar will also include an introduction to the While We Wait service model, what it offers, and how it works, which will be delivered by a member of the research team. GPs who agree will be sent a personal link to the webinar, which enables individual tracking. Within no more than 7 days of completing the webinar, the research team will contact the GPs by email and telephone to confirm their understanding of the study and finalise their consent to participate in the study. At this time, GPs will also complete the baseline study assessment, which consists of an online survey of self report measures, taking approximately 10 minutes. Within a minimum of three days after providing their consent and the baseline, GPs will be given access to their referral link, which will enable them to begin referring their adolescent patients into the study. • A self-reported psycho-social assessment for each of their participating adolescent patients: Adolesent patients who are referred into the service and consent to take part will have their responses to a set of the self-reported mental health measures completed in the adolescent's baseline assessment (Need for Other Supports - GP Users Perceived Needs Inventory; Suicidal Ideation Attributes Scale; Single item Non-Suicidal Self-injury Screener; Weight Concerns Scale) extracted using software by the research team to form a psycho-social report. This individual report will be returned to the adolescent's participating GP via HealthLink - a secure messaging service. This report is designed to help GPs determine whether their adolescent patient has been referred to an appropriate mental health service. The report consists of a 1-page summary of the participating adolescent participant's scores for suicide risk, self-harm, eating disorders, and any additional psychosocial support that is needed. The report also includes an appendix of resources for the GP about how to respond to this information, which were collated from pre-existing Australian-based resources. A summary of the report is also emailed directly from the survey platform to each adolescent participant for their records. This report is delivered to the GPs once for each participating adolescent, sent after the adolescent has completed their baseline assessment. For adolescent participants: • Pre-service and baseline procedure: Adolescents will be informed about the study by their participating GP in their mental health appointment. Eligible adolescents who agree to having their contact information shared with the research team will be sent a text message with a link to the study information by the research team within three days of expressing interest. The link will contain the Adolescent Participant Information and Consent Form. Upon completion of this (within 7 days or otherwise withdrawn), the adolescent's parent or guardian will then be sent (by the research team) a link to the Parent Participant Information Sheet and Consent Form. Once this is completed (within 7 days or otherwise withdrawn), the adolescent will receive another text message from the research team, which contains a link to the self-report baseline assessment. The baseline assessment contains a battery of self-report questionnaires and takes approximately 30 minutes to complete. It can be completed on any internet device and adolescents will have up to 7 days to complete the assessment before being withdrawn from the study. Adolescents will begin receiving the While We Wait service components from completion of the baseline assessment. The While We Wait service is a complex intervention consisting of subcomponents that are delivered to adolescent participants over a period of three months. The intervention subcomponents of the service include: • Their self-report psycho-social assessment: Adolesent patients who are referred into the service and consent to take part will have their responses to a set of the self-reported mental health measures completed in the adolescent's baseline assessment (Need for Other Supports - GP Users Perceived Needs Inventory; Suicidal Ideation Attributes Scale; Single item Non-Suicidal Self-injury Screener; Weight Concerns Scale) extracted using software by the research team to form a psycho-social report. This individual report will be returned to the adolescent's participating GP via HealthLink - a secure messaging service. This report is designed to help GPs determine whether their adolescent patient has been referred to an appropriate mental health service. The report consists of a 1-page summary of the participating adolescent participant's scores for suicide risk, self-harm, eating disorders, and any additional psychosocial support that is needed. The report also includes an appendix of resources for the GP about how to respond to this information, which were collated from pre-existing Australian-based resources. A summary of the report is also emailed directly from the survey platform to each adolescent participant for their records. This report is delivered to the GPs once for each participating adolescent, sent after the adolescent has completed their baseline assessment. • Project YES: This is a web-based platform that contains a suite of three evidence-based Digital Single Session Interventions (D-SSI) that each focus on a proven psychological strategy, including the Growth Mindset (Project Personality), Behavioural Activation (The ABC Project ), and Self-care and Kindness (Project CARE). Each D-SSI includes psychoeducation, scientific explanations, and peer stories; empowers adolescents by encouraging them to offer advice to others; and encourages participation in guided writing activities. All of the D-SSIs included in Project YES have been evaluated in trials conducted by other research groups with more information available in the protocol. Each D-SSI is designed to be completed in a single sitting in under 30 minutes. In the current trial, the While We Wait service encourages (through written instructions) that the adolescent participants complete the D-SSI focused on the growth mindset (Project Personality). Project Personality has been embedded into wait lists and primary care in the US and UK. For this project, we adapted Project Personality to use Australian language with a reading level of Grade 7, and Australian-English voice recordings. The other D-SSIs offered (ABC Project, Project CARE) have not been adapted into an Australian version but are available to participants in this trial with the original American text and recordings. Adolescent participants are invited to complete one D-SSI of their choice immediately after their completion of the baseline assessment. Adherence will be tracked using embedded data on the Project YES website that is linked to a unique participant identifier. After completing their first selected Project YES activity, adolescent participants are informed that they can return to Project YES at any time throughout the study period to repeat the activity, or to complete the other D-SSIs. Adolescents who complete baseline will have access to Project YES for the full duration of the study (3 months). • Small Steps: This is an evidence-based, 9-week automated SMS intervention that delivers “bite size” self-management skills, support, check-ins, and psychoeducation to adolescent participants on a pre-programmed schedule. Each week focuses on one psychological strategy, with a total of 9 strategies covered (including help-seeking, self-compassion, valued living, daily routines, behavioural activation, problem solving, cognitive restructuring, connectedness, gratitude), with an optional 2 strategies that participants’ can ‘swap out’ if they wish (relaxation, willingness). Adolescent participants receive three consecutive days of strategy-based text message content per week (e.g. Today, see how your mood changes when you do a small, rewarding or fun activity'), plus an additional day of reflective writing prompts, and a day of pre-programmed peer messages prompts. Developed in the US, we have adapted Small Steps for weekly delivery to young Australian adolescents on wait lists in partnership with Youth with Lived Experience. This entirely automated intervention is delivered using a custom-built software platform (Audacious Software) located in Australia, with Twilio text message integration. Communication will be two-way as participants will be prompted to respond to the text messages they receive (e.g. 'Text back the activity you are planning'). However, all of the messages sent by the program (e.g. 'Thank you for sharing') are pre-programmed and any replies from participants are not monitored by the research team. Participants are able to pause or adjust the messages by replying to the pre-programmed text messages. For example 'Do you want to see more content like this in the future? Reply yes or no'. Adherence will be tracked using embedded data on Audacious Software that is linked to a unique participant identifier. Small Steps will commence for adolescent participants on the first Monday following their baseline completion to ensure that the pre-programmed content is delivered and received on weekdays (5 days content), with breaks in content over the weekend (2 days break).
Sponsors
Study design
Eligibility
Inclusion criteria
Eligible medical practicess must be: Located in the target PHN regions (CESPHN and Coordinare); Have at least 1 participating GP that treats adolescents aged 14 to 17 years with mental health problems; Have access to the digital infrastructure to support secure messaging (HealthLink); Must have a representative to complete the Medical Practice Registration Form. GP inclusion criteria: The study is suitable for GPs who: Treat adolescents aged 14 to 17 years with mental health problems and make referrals to mental health specialists or services for these patients; Are working in a participating medical practice in the target PHN regions (CESPHN and Coordinare); Have the capacity to communicate the trial information to their adolescent patients and their families in appointments. Adolescent inclusion criteria: Aged 14-17; Are being treated by a GP in the study; Have been referred by a participating GP for mental health treatment and assessment (e.g., to a specialist, service, or program) and are likely to experience a wait time for this; Can obtain a parent/guardian’s consent to participate; Have access to their own smartphone and the Internet; Can read English at Year 7 reading level; Are living or accessing treatment in the areas where the study is taking place (CESPHN and Coordinare); Are considered by their GP to be suitable, which means having the capacity to participate in the research study, including the ability to engage with an automated digital support service; Can attend a follow-up appointment with their GP two weeks after signing up to the study. Parent eligibility criteria: Must be parent of participating adolescent; Can read English at Grade 7 reading level; Have an active email and/or smartphone to enable completion of study questionnaires.
Exclusion criteria
Medical practice exclusion criteria: Not located within the participating regions (CESPHN and Coordinare); Do not have the technical capabilities to receive secure messages from HealthLink; Do not complete the registration form within the recruitment period. GP exclusion criteria: GPs will be excluded if: Their regular location of work is not within the participating regions; They do not treat adolescent patients aged 14 to 17 years; They do not make mental health treatment plans or referrals to mental health specialists and treatment providers for their adolescent patients; They are unable to offer a bulk-billed follow-up appointment within two weeks of the initial consultation for participating adolescent patients, and invoice the research team for reimbursement of any out-of-pocket (gap) payments (up to $80 per participant). Adolescent exclusion criteria: At the time of screening, adolescents will be excluded if they: Have not been referred into the service by an enrolled GP; are unable to gain parental consent to participate (as determined by failure to return parental consent form within their recruitment period); Fail to satisfy the Gillick Competence Measure embedded in the consent form. There are no exclusions based on diagnosis, severity, or current medication use. As above, GPs are asked to consider suitability based on the young person's overall level of distress, current engagement with mental health services, and their ability to benefit from and safely engage with digital support while awaiting treatment. Parent exclusion criteria: No exclusions apply.