A Serious Game for Young People With First Episode Psychosis (OnTrack>The Game): Qualitative Findings of a Randomized Controlled Trial

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 description of the intervention) may also be applicable for other study designs.

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This information was included in the methods section of the manuscript. It was not elaborated on in the abstract because this manuscript focused the qualitative results of the intervention.
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In the current study, we refined and augmented OTG utilizing clinician and client feedback (e.g. Youth Advisory Board comprised of individuals with FEP) and tested it in an RCT comparing the short (2 months) and long term (5 months) effects of OTG versus recovery videos (RV) on engagement, stigma, empowerment, hope, recovery, and understanding of psychosis. Recovery videos were chosen as the comparison group due to pilot study participants reporting recovery videos as the most valued game feature [12]. In the current study we wanted to determine whether the videos alone were producing an effect on our domains of interest or if the videos embedded in the game in addition to other game elements were creating an effect." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants)." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Inclusion criteria was: a diagnosis of non-affective psychosis and receiving services at a CSC program, ages 16-30, English speaking, able to give fully-informed consent, access to the internet with a personal computer or tablet (sites provide access to computers or tablets onsite if this is a barrier), and access to email." Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were initially recruited from 18 clinical sites in the OnTrackNY network, a CSC program in New York State. Due to recruitment challenges imposed by the COVID-19 pandemic 57 of the 159 participants were recruited online from various CSC programs across the country." Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Quantitative outcomes were self-assessed through online questionnaires. Our study reported on qualitative outcomes. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Inclusion criteria was: a diagnosis of non-affective psychosis and receiving services at a CSC program, ages 16-30, English speaking, able to give fully-informed consent, access to the internet with a personal computer or tablet (sites provide access to computers or tablets onsite if this is a barrier), and access to email." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Based on the feedback, we improved the game's functionality (changing to a new platform that allows mobile use, developing a smartphone interface), included more quests and interactions with non-player characters, expanded the video library, added more customization features to the main character (hair, facial features, body type), and provided rewards for collecting points such as opportunities to upgrade the avatar's outfit and decorate their apartment. We also included an in-game computer with links to information about psychosis, treatment options, and wellness strategies."..."Quests provided opportunities to engage in decision making and view potential consequences of these decisions. For example, in one scenario the player was given the wrong drink at a coffee shop and had to decide how to respond, and in another, the player had to decide whether to engage in a social interaction with a neighbor. These scenarios provided individuals with the opportunity to practice social skills, see the outcomes of potential responses, and receive immediate feedback in a safe environment mimicking potential real world situations, designed to promote empowerment, hope, and recovery. Resources available on the in-game computer and the recovery videos triggered throughout the game (and also comprising the RV condition) provided opportunities for psychoeducation and promoted stories of hope and recovery in individuals with psychosis. " Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were provided basic instructions on how to access and navigate the intervention to which they were assigned and were given two months to play the entire game or watch all recovery videos. They were also encouraged to use OTG/RV on a weekly basis throughout that two-month period." Participants were emailed weekly reminders to play the game/watch the videos. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Client interview questions were intended to elaborate on quantitative measures and included questions about the game's influence on treatment engagement, recovery, empowerment, hope, understanding of psychosis, and stigma, which was divided into selfstigma and public stigma...Questions corresponding to each domain are included in Table 1. Additional questions were related to potential technical difficulties, favorite and least favorite aspects, frequency of use, relevance to experiences with symptoms and treatment, and recommendations for improvement.

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Clinician interviews asked questions about: whether game/videos were discussed in session; most helpful or least helpful aspects; perceived changes in client interactions with team and attitudes; whether they would recommend the game/videos to other clients; perceived barriers to client utilization and ways to encourage individuals to use the products; and recommendations for improvement."  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants)." Quantitative study randomization information will be provided in a separate manuscript. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants)." Quantitative study randomization information will be provided in a separate manuscript. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Quantitative study randomization information will be provided in a separate manuscript. Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants). Of 42 individuals who provided consent to contact for the qualitative study, 39 were contacted and 16 agreed to participate in the interview (5 in the RV and 11 in OTG groups). Of the 23 participants who were contacted but did not participate, 3 had difficulties with scheduling, 8 declined, and 12 did not respond or had invalid contact information."..."Nine clinicians from CSC programs (1 with a client in RV group and 8 with clients in both OTG and RV groups) were enrolled in the qualitative study between 6/25/20 and 8/31/20." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020. We planned to enroll 20 clients in a 1:1 ratio (e.g., 10 OTG participants and 10 RV participants). Of 42 individuals who provided consent to contact for the qualitative study, 39 were contacted and 16 agreed to participate in the interview (5 in the RV and 11 in OTG groups). Of the 23 participants who were contacted but did not participate, 3 had difficulties with scheduling, 8 declined, and 12 did not respond or had invalid contact information. Unfortunately, we faced difficulties engaging participants from the RV group. Some RV participants indicated they did not want to stay involved in the study after finding out they would not be able to play OTG and some did not want to complete additional assessments. Nine clinicians from CSC programs (1 with a client in RV group and 8 with clients in both OTG and RV groups) were enrolled in the qualitative study between 6/25/20 and 8/31/20." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "For the qualitative study, a subsample of participants from the OTG and RV groups who agreed to be contacted were recruited between 7/22/20 and 12/1/2020."... "Nine clinicians from CSC programs (1 with a client in RV group and 8 with clients in both OTG and RV groups) were enrolled in the qualitative study between 6/25/20 and 8/31/20." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is not applicable to our study. The trial ended as expected. Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Of 42 individuals who provided consent to contact for the qualitative study, 39 were contacted and 16 agreed to participate in the interview (5 in the RV and 11 in OTG groups)."..."Nine clinicians from CSC programs (1 with a client in RV group and 8 with clients in both OTG and RV groups) were enrolled in the qualitative study" Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i). In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).  D  I  S  C  U  S  S  I  O  N   2  2  )  I  n  t  e  r  p  r  e  t  a  t  i  o  n  c  o  n  s  i  s  t  e  n  t  w  i  t  h  r  e  s  u  l  t  s  ,  b  a  l  a  n  c  i  n  g  b  e  n  e  f  i  t  s  a  n  d  h  a  r  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study qualitatively examined the impact of OTG/RV on engagement, stigma, empowerment, hope, recovery, and understanding of psychosis in clients receiving CSC. Common themes for clients included relatability, increased hope and possibility of recovery, decreased self and public stigma, and increased understanding of the importance of family/social support, while OTG participants reported increased empowerment. Clinicians strongly preferred RV and offered suggestions for dissemination/implementation for both OTG and RVs including providing clients with computers or tablets, advertising the products through social media or a website, having families facilitate dissemination, and utilizing the products during onboarding of providers and during initial sessions with clients."