Sally Merry

BACKGROUND Depressive symptoms are common across populations worldwide. In Japan, a nationwide survey of more than 8,000 adults reported that approximately one-fifth of respondents experienced clinically significant anxiety or depressive symptoms. Depressive symptoms are associated with impaired work functioning, reduced quality of life, and increased suicide risk, yet access to evidence-based psychological treatments remains limited. Mobile health (mHealth) interventions have the potential to increase access to psychological support by enabling self-guided use independent of time and location. Computerized cognitive behavioral therapy (cCBT) has been shown to reduce depressive symptoms in adolescents and adults; however, engagement and attrition remain key challenges in unguided digital interventions. SPARX is a game-based CBT program originally developed for adolescents, consisting of seven modules delivered through an interactive fantasy game. While previous randomized controlled trials have demonstrated benefits of SPARX under controlled conditions, less is known about its use and outcomes when delivered in real-world settings, particularly among adult users in Japan. OBJECTIVE This study aimed to examine changes in depressive symptoms associated with use of SPARX, a game-based cognitive behavioral therapy application, among Japanese adults in a real-world setting, and to explore whether symptom trajectories differed by age or baseline depressive symptom severity. METHODS This was a real-world repeated measures observational study of individuals who used SPARX in Japan between May 2016 and July 2021. In total, 5,374 individuals registered to use SPARX, and 3,367 users met the following eligibility criteria: (1) aged 20–69 years at the time of registration, and (2) having completed at least Module 1 of SPARX. Each user purchased the Japanese version of SPARX from the Apple App Store or Android Google Play Store. The primary outcome measure was the Japanese version of the Patient Health Questionnaire-9. Linear mixed model (LMM) analysis was used to examine changes in depressive symptom scores across program modules, comparing Module 4 and Module 7 with Module 1. RESULTS Overall, 3,367 individuals aged 20–69 years (2,925 men and 410 women; mean age = 34.28 years, SD = 9.28) completed Module 1. Linear mixed model analyses showed significant reductions in depressive symptom scores over program use among those who progressed through later modules. Reductions were observed at Module 4 (n = 1,356; estimate = −2.87, t = −15.40, p < .05, d = 0.69, 95% CI [0.53, 0.84]) and at Module 7 (n = 844; estimate = −4.57, t = −19.23, p < .05, d = 1.06, 95% CI [0.86, 1.27]). CONCLUSIONS In this large real-world repeated measures observational study without a control group, use of SPARX among Japanese adults was associated with improvements in self-reported depressive symptom scores among users who progressed through later modules. Although causal inferences regarding effectiveness cannot be made, these findings provide evidence on usage patterns and symptom trajectories of a game-based CBT program originally developed for adolescents when delivered to an adult population in a naturalistic setting.

Background: Internet-based cognitive behavioral therapy (iCBT) interventions are effective in clinical trials; however, iCBT implementation data are seldom reported. Objective: The objective of this study is to evaluate uptake, adherence, and changes in symptoms of depression for 12‐ to 19-year-olds using an unguided pure self-help iCBT intervention (SPARX; Smart, Positive, Active, Realistic, X-factor thoughts) during the first 7 years of it being publicly available without referral in Aotearoa New Zealand. Methods: SPARX is a 7-module, self-help intervention designed for adolescents with mild to moderate depression. It is freely accessible to anyone with a New Zealand Internet Protocol address, without the need for a referral, and is delivered in an unguided “serious game” format. The New Zealand implementation of SPARX includes 1 symptom measure—the Patient Health Questionnaire adapted for Adolescents (PHQ-A)—which is embedded at the start of modules 1, 4, and 7. We report on uptake, the number of modules completed, and changes in depressive symptoms as measured by the PHQ-A. Results: In total, 21,320 adolescents aged 12 to 19 years (approximately 2% of New Zealand 12‐ to 19-year-olds) registered to use SPARX. Of these, 63.6% (n=13,564; comprising n=8499, 62.7% female, n=4265, 31.4% male, and n=800, 5.9% another gender identity or gender not specified; n=8741, 64.4% New Zealand European, n=1941, 14.3% Māori, n=1202, 8.9% Asian, n=538, 4.0% Pacific, and n=1142, 8.4% another ethnic identity; mean age 14.9, SD 1.9 years) started SPARX. The mean PHQ-A at baseline was 13.6 (SD 7.7) with 16.1% (n=1980) reporting no or minimal symptoms, 37.4% (n=4609) reporting mild to moderate symptoms (ie, the target group) and 46.7% (n=5742) reporting moderately severe or severe symptoms. Among those who started, 51.1% (n=6927) completed module 1, 7.4% (n=997) completed at least 4 modules, and 3.1% (n=416) completed all 7 modules. The severity of symptoms reduced from baseline to modules 4 and 7. Mean PHQ-A scores for baseline, module 4, and module 7 for those who completed 2 or more assessments were 14.0 (SD 7.0), 11.8 (SD 7.9), and 10.5 (SD 8.5), respectively; mean difference for modules 1-4 was 2.2 (SD 5.7; P<.001) and for modules 1-7 was 3.6 (SD 7.0; P<.001). Corresponding effect sizes were 0.38 (modules 1-4) and 0.51 (modules 1-7). Conclusions: SPARX reached a meaningful proportion of the adolescent population. The effect size for those who engaged with it was comparable to trial results. However, completion was low. Key challenges included logistical barriers such as slow download speeds and compatibility with some devices. Ongoing attention to rapidly evolving technologies and engagement with them are required. Real-world implementation analyses offer important insights for understanding and improving the impact of evidence-based digital tools and should be routinely reported.

Background: This study explored the feasibility, acceptability, and Māori cultural responsivity of study methods and components of an intervention to support clinicians to resume implementation of Parent–Child Interaction Therapy (PCIT), an evidence-based treatment for disruptive behavior in young children. Method: This pragmatic, parallel-arm, randomized, controlled pilot trial ran for a 6-month period and included PCIT-trained clinicians who were not delivering, or only rarely using PCIT in their work. Re-implementation strategies were systematically developed and theory-driven and included a mobile co-worker, a portable time-out space, audio-visual equipment, weekly consultation groups, and 2-day targeted PCIT refresher training. Results: Pre-specified progression criteria included enrolling 20 clinicians, a maximum of 20% attrition, and a monthly survey response rate of at least 80%. Fourteen clinicians enrolled in the trial, there was no attrition, and an 89.8% average survey response rate was achieved. Secondary outcomes included clinician ratings of the usefulness and acceptability of intervention components. The time-out cubicle was considered relatively less useful and acceptable, while the refresher training and manuals were preferred. Study methods and intervention components were considered acceptable by the small proportion of Māori participants. Clinician self-reported Capability, Opportunity, and Motivation to implement PCIT fluctuated monthly across both groups. Pre-/post-changes in each domain within the Theoretical Domains Framework generally showed similar improvement from baseline to follow-up in both groups. There was no observable difference in PCIT adoption in either group. Conclusion: To the best of our knowledge, this is the first study to pragmatically attempt to re-implement a parent training intervention in a community setting, several years after clinicians’ initial training in the approach (here, an average of 5.36 years). Low attrition and high survey response rates highlighted the feasibility of the data collection methodology. Important opportunities to improve the design of an adequately powered definitive trial are highlighted to minimize future resource waste.

Parent–Child Interaction Therapy (PCIT) is an empirically supported treatment for childhood conduct problems, with increasing numbers of clinicians being trained in Aotearoa/New Zealand. However, ensuring sustained delivery of effective treatments by trained clinicians in routine care environments is notoriously challenging. The aims of this qualitative study were to (1) systematically examine and prioritise PCIT implementation barriers and facilitators, and (2) develop a well specified and theory-driven ‘re-implementation’ intervention to support already-trained clinicians to resume or increase their implementation of PCIT. To triangulate and refine existing understanding of PCIT implementation determinants from an earlier cross-sectional survey, we integrated previously unanalysed qualitative survey data (54 respondents; response rate 60%) with qualitative data from six new focus groups with 15 PCIT-trained clinicians and managers in Aotearoa/New Zealand. We deductively coded data, using a directed content analysis process and the Theoretical Domains Framework, resulting in the identification of salient theoretical domains and belief statements within these. We then used the Theory and Techniques Tool to identify behaviour change techniques, possible intervention components, and their hypothesised mechanisms of action. Eight of the 14 theoretical domains were identified as influential on PCIT-trained clinician implementation behaviour (Knowledge; Social/Professional Role and Identity; Beliefs about Capabilities; Beliefs about Consequences; Memory, Attention and Decision Processes; Environmental Context and Resources; Social Influences; Emotion). Two of these appeared to be particularly salient: (1) ‘Environmental Context and Resources’, specifically lacking suitable PCIT equipment, with (lack of) access to a well-equipped clinic room appearing to influence implementation behaviour in several ways. (2) ‘Social/Professional Role and Identity’, with beliefs relating to a perception that colleagues view time-out as harmful to children, concerns that internationally-developed PCIT is not suitable for non-Māori clinicians to deliver to Indigenous Māori families, and clinicians feeling obligated yet isolated in their advocacy for PCIT delivery. In conclusion, where initial implementation has stalled or languished, re-implementation may be possible, and makes good sense, both fiscally and practically. This study suggests that re-implementation of PCIT in Aotearoa/New Zealand may be facilitated by intervention components such as ensuring access to a colleague or co-worker who is supportive of PCIT delivery, access to suitable equipment (particularly a time-out room), and targeted additional training for clinicians relating to the safety of time-out for children. The feasibility and acceptability of these intervention components will be tested in a future clinical trial.

Introduction A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Methods and analysis Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13–19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. Ethics and dissemination The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration number ISRCTN12437531.

Background: Despite a number of clinicians having been trained in Parent–Child Interaction Therapy (PCIT) in Aotearoa/New Zealand, few are regularly delivering the treatment, with barriers to use including a lack of suitable equipment and lack of professional support. This pragmatic, parallel-arm, randomised, controlled pilot trial includes PCIT-trained clinicians who are not delivering, or only rarely utilising, this effective treatment. The study aims to assess the feasibility, acceptability and cultural responsivity of study methods and intervention components and to collect variance data on the proposed future primary outcome variable, in preparation for a future, larger trial. Methods: The trial will compare a novel ‘re-implementation’ intervention with a refresher training and problem-solving control. Intervention components have been systematically developed to address barriers and facilitators to clinician use of PCIT using implementation theory, and a draft logic model with hypothesised mechanisms of action, derived from a series of preliminary studies. The intervention includes complimentary access to necessary equipment for PCIT implementation (audio-visual equipment, a ‘pop-up’ time-out space, toys), a mobile senior PCIT co-worker and an optional weekly PCIT consultation group, for a 6-month period. Outcomes will include the feasibility of recruitment and trial procedures; acceptability of the intervention package and data collection methods to clinicians; and clinician adoption of PCIT. Discussion: Relatively little research attention has been directed at interventions to resurrect stalled implementation efforts. Results from this pragmatic pilot RCT will refine and shape knowledge relating to what it might take to embed the ongoing delivery of PCIT in community settings, providing more children and families with access to this effective treatment. Trial registration: ANZCTR, ACTRN12622001022752, registered on July 21, 2022.

Background: Up to 6 years after the 2011 Christchurch earthquakes, approximately one-third of parents in the Christchurch region reported difficulties managing the continuously high levels of distress their children were experiencing. In response, an app named Kākano was co-designed with parents to help them better support their children’s mental health. Objective: The objective of this study was to evaluate the acceptability, feasibility, and effectiveness of Kākano, a mobile parenting app to increase parental confidence in supporting children struggling with their mental health. Methods: A cluster-randomized delayed access controlled trial was carried out in the Christchurch region between July 2019 and January 2020. Parents were recruited through schools and block randomized to receive immediate or delayed access to Kākano. Participants were given access to the Kākano app for 4 weeks and encouraged to use it weekly. Web-based pre- and postintervention measurements were undertaken. Results: A total of 231 participants enrolled in the Kākano trial, with 205 (88.7%) participants completing baseline measures and being randomized (101 in the intervention group and 104 in the delayed access control group). Of these, 41 (20%) provided full outcome data, of which 19 (18.2%) were for delayed access and 21 (20.8%) were for the immediate Kākano intervention. Among those retained in the trial, there was a significant difference in the mean change between groups favoring Kākano in the brief parenting assessment (F1,39=7, P=.012) but not in the Short Warwick-Edinburgh Mental Well-being Scale (F1,39=2.9, P=.099), parenting self-efficacy (F1,39=0.1, P=.805), family cohesion (F1,39=0.4, P=.538), or parenting sense of confidence (F1,40=0.6, P=.457). Waitlisted participants who completed the app after the waitlist period showed similar trends for the outcome measures with significant changes in the brief assessment of parenting and the Short Warwick-Edinburgh Mental Well-being Scale. No relationship between the level of app usage and outcome was found. Although the app was designed with parents, the low rate of completion of the trial was disappointing. Conclusions: Kākano is an app co-designed with parents to help manage their children’s mental health. There was a high rate of attrition, as is often seen in digital health interventions. However, for those who did complete the intervention, there was some indication of improved parental well-being and self-assessed parenting. Preliminary indications from this trial show that Kākano has promising acceptability, feasibility, and effectiveness, but further investigation is warranted. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12619001040156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377824&isReview=true

Background and Objectives: Now more than ever, there is an obvious need to reduce the overall burden of disease and risk of premature mortality that are associated with mental health and substance use disorders among young people. However, the current state of research and evidence-based clinical care for high-risk substance use among youth is fragmented and scarce. The objective of the study is to establish consensus for the prevention, treatment, and management of high-risk substance use and overdose among youth (10 to 24 years old). Materials and Methods: A modified Delphi technique was used based on the combination of scientific evidence and clinical experience of a group of 31 experts representing 10 countries. A semi-structured questionnaire with five domains (clinical risks, target populations, intervention goals, intervention strategies, and settings/expertise) was shared with the panelists. Based on their responses, statements were developed, which were subsequently revised and finalized through three iterations of feedback. Results: Among the five major domains, 60 statements reached consensus. Importantly, experts agreed that screening in primary care and other clinical settings is recommended for all youth, and that the objectives of treating youth with high-risk substance use are to reduce harm and mortality while promoting resilience and healthy development. For all substance use disorders, evidence-based interventions should be available and should be used according to the needs and preferences of the patient. Involuntary admission was the only topic that did not reach consensus, mainly due to its ethical implications and resulting lack of comparable evidence. Conclusions: High-risk substance use and overdoses among youth have become a major challenge. The system’s response has been insufficient and needs substantial change. Internationally devised consensus statements provide a first step in system improvement and reform.

BACKGROUND Up to 6 years after the 2011 Christchurch earthquakes, approximately one-third of parents in the Christchurch region reported difficulties managing the continuously high levels of distress their children were experiencing. In response, an app named Kākano was co-designed with parents to help them better support their children’s mental health. OBJECTIVE The objective of this study was to evaluate the acceptability, feasibility, and effectiveness of Kākano, a mobile parenting app to increase parental confidence in supporting children struggling with their mental health. METHODS A cluster-randomized delayed access controlled trial was carried out in the Christchurch region between July 2019 and January 2020. Parents were recruited through schools and block randomized to receive immediate or delayed access to Kākano. Participants were given access to the Kākano app for 4 weeks and encouraged to use it weekly. Web-based pre- and postintervention measurements were undertaken. RESULTS A total of 231 participants enrolled in the Kākano trial, with 205 (88.7%) participants completing baseline measures and being randomized (101 in the intervention group and 104 in the delayed access control group). Of these, 41 (20%) provided full outcome data, of which 19 (18.2%) were for delayed access and 21 (20.8%) were for the immediate Kākano intervention. Among those retained in the trial, there was a significant difference in the mean change between groups favoring Kākano in the brief parenting assessment (F1,39=7, P=.012) but not in the Short Warwick-Edinburgh Mental Well-being Scale (F1,39=2.9, P=.099), parenting self-efficacy (F1,39=0.1, P=.805), family cohesion (F1,39=0.4, P=.538), or parenting sense of confidence (F1,40=0.6, P=.457). Waitlisted participants who completed the app after the waitlist period showed similar trends for the outcome measures with significant changes in the brief assessment of parenting and the Short Warwick-Edinburgh Mental Well-being Scale. No relationship between the level of app usage and outcome was found. Although the app was designed with parents, the low rate of completion of the trial was disappointing. CONCLUSIONS Kākano is an app co-designed with parents to help manage their children’s mental health. There was a high rate of attrition, as is often seen in digital health interventions. However, for those who did complete the intervention, there was some indication of improved parental well-being and self-assessed parenting. Preliminary indications from this trial show that Kākano has promising acceptability, feasibility, and effectiveness, but further investigation is warranted. CLINICALTRIAL Australia New Zealand Clinical Trials Registry ACTRN12619001040156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377824&isReview=true

SUMMARY: Depression and anxiety are common in adolescents, but most affected will not get any formal help. Digital mental health technologies (i.e. resources and interventions to support and improve mental health) are a potential way to extend the reach and increase adolescents’ access to therapies, at a relatively low cost. Many young people can access the internet and mobile technologies, including in low- and middle-income countries. There has been increased interest in integrating technologies in a range of settings, especially because of the effect of the COVID-19 pandemic on adolescent mental health, at a time when services are under pressure. This clinical review gives an overview of digital technologies to support the prevention and management of depression and anxiety in adolescence. The technologies are presented in relation to their technological approaches, underlying psychological or other theories, setting, development, evaluations to date and how they might be accessed. There is also a discussion of the potential benefits, challenges and future developments in this field.