RESUMO
We aim to review the association between childhood-onset mental health conditions and increased risk for early substance use including opioid misuse and opioid use disorders (OUD). The association between mental health conditions and opioid misuse suggests youth with mental health conditions may benefit from opioid prevention efforts that concurrently address mental health. To aid in the identification of youth with mental health conditions who could benefit from interventions, we will review opportunities and challenges associated with screening for mental health symptoms or substance use in settings where youth at high risk for mental health conditions present. We will also review how research projects within the National Institutes of Health's Helping to End Addiction Long-term (HEAL) Prevention Cooperative are addressing mental health within opioid misuse and OUD prevention interventions for youth.
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Comportamento Aditivo , Transtornos Relacionados ao Uso de Opioides , Adolescente , Humanos , Criança , Saúde Mental , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/etiologia , Analgésicos OpioidesRESUMO
The Helping to End Addiction Long-Term (HEAL) Prevention Cooperative (HPC) is rapidly developing 10 distinct evidence-based interventions for implementation in a variety of settings to prevent opioid misuse and opioid use disorder. One HPC objective is to compare intervention impacts on opioid misuse initiation, escalation, severity, and disorder and identify whether any HPC interventions are more effective than others for types of individuals. It provides a rare opportunity to prospectively harmonize measures across distinct outcomes studies. This paper describes the needs, opportunities, strategies, and processes that were used to harmonize HPC data. They are illustrated with a strategy to measure opioid use that spans the spectrum of opioid use experiences (termed involvement) and is composed of common "anchor items" ranging from initiation to symptoms of opioid use disorder. The limitations and opportunities anticipated from this approach to data harmonization are reviewed. Lastly, implications for future research cooperatives and the broader HEAL data ecosystem are discussed.
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Analgésicos Opioides , Transtornos Relacionados ao Uso de Opioides , Humanos , Ecossistema , Estudos Prospectivos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , CogniçãoRESUMO
BACKGROUND: Preventing tobacco product initiation in youth is a critical need. While cigarette smoking among youth has been on the decline, tobacco use in other forms, such as e-cigarettes and vaping, continue to be a major concern. The purpose of this study was to conduct a real-world, quasi-experimental test of the effectiveness of a web-based videogame, smokeSCREEN, aimed at developing healthy beliefs and knowledge associated with tobacco product use prevention, including electronic cigarettes. Methods: Adolescents (N = 560) aged 10-16 years were enrolled from schools and afterschool programs in a single-group pre-post study. Measures included a pre- and post-survey of beliefs and knowledge about tobacco product use. At post-survey, participants were asked questions regarding their gameplay experience. Paired responses for the tobacco product use in the beliefs and knowledge survey before and after the smokeSCREEN videogame intervention were compared using McNemar's test. Descriptive statistics were generated to assess overall participant gameplay experience. Results: McNemar's test showed significant differences in the proportions of correct answers before (pre-survey) and after (post-survey) the intervention in seven out of eight belief questions (p < . 0001). It also suggested significant differences in the proportions of correct answers before (pre-survey) and after (post-survey) the intervention in all six knowledge questions (p < . 0001). Several gender and age differences were noted for belief and knowledge questions related to e-cigarettes and vaping. There was no association between gameplay duration at post-survey or to the answers of the beliefs or knowledge questions. Overall, participants reported that they enjoyed playing the game. Conclusions: Findings suggest that the videogame intervention, smokeSCREEN, has a promising effect on participants' beliefs and knowledge about tobacco product use, including electronic cigarettes and vaping, and is well accepted by adolescents.
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Sistemas Eletrônicos de Liberação de Nicotina , Intervenção Baseada em Internet , Produtos do Tabaco , Jogos de Vídeo , Adolescente , Humanos , Uso de TabacoRESUMO
We sought to test the efficacy of extended-release naltrexone (XR-NTX) on HIV-related and drinking outcomes. From April 2011-February 2015, we conducted a 4-site randomized double-blind placebo controlled clinical trial involving 51 HIV-positive patients with heavy drinking and < 95% antiretroviral (ART) adherence. All participants received counseling. The primary outcome was proportion with ≥ 95% ART adherence. Secondary outcomes included HIV biomarkers, VACS Index score, and past 30-day heavy drinking days. Based on receipt of ≥ 5 injections, 23 participants were retained at 24 weeks. We did not detect an effect of XR-NTX on ART adherence (p = 0.38); undetectable HIV viral load (p = 0.26); CD4 cell count (p = 0.75) or VACS Index score (p = 0.70). XR-NTX was associated with fewer heavy drinking days (p = 0.03). While XR-NTX decreases heavy drinking days, we did not detect improvements in ART adherence or HIV outcomes. Strategies to improve retention in alcohol treatment and HIV-related outcomes among heavy drinking HIV-positive patients are needed.
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Alcoolismo/tratamento farmacológico , Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Naltrexona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Adulto , Consumo de Bebidas Alcoólicas , Contagem de Linfócito CD4 , Aconselhamento , Preparações de Ação Retardada , Método Duplo-Cego , Feminino , HIV , Infecções por HIV/sangue , Humanos , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
BACKGROUND: Videogames are becoming increasingly popular to deliver health interventions; however, their role in the primary prevention of cigarette and marijuana use has not yet been evaluated. The purpose of this study was to conduct a preliminary test of the efficacy of a role-playing videogame prototype, smokeSCREEN, aimed at developing knowledge and behavioral skills associated with primary prevention of cigarette and marijuana use. The authors also explored participants' gameplay experience. METHODS: This study employed a 1-group pretest-posttest design with 25 adolescent boys and girls aged 11 to 14 years (Mage = 11.56, SD = 0.77) who had never tried cigarettes or marijuana. Participants played four 1-hour gameplay sessions over a 2-week period. Assessments of knowledge, self-efficacy, attitudes, perceived norms, and intentions related to cigarette and marijuana prevention were collected at baseline and 2-week and 12-week follow-ups. Ratings of gameplay experience were collected after the 2 weeks of gameplay. One-way repeated-measures analyses of variance (ANOVAs) were conducted. RESULTS: Findings are (1) improvements in knowledge for both cigarette (Wilks' λ = 0.62, F(2, 23) = 7.21, P = .004) and marijuana (Wilks' λ = 0.67, F(2, 23) = 5.75, P = .009) use from pre- to post-gameplay that were characterized by large effects; and (2) nonsignificant trends in the expected direction emerged for changes in self-efficacy and perceived norms related to both cigarettes and marijuana that were characterized by medium-large effects. Overall, the players provided positive reports of their experience with the smokeSCREEN videogame prototype. CONCLUSIONS: These findings provide preliminary evidence that a videogame has the potential to influence key cognitive and motivational variables and can be an engaging means to deliver a cigarette and marijuana prevention intervention.
Assuntos
Comportamento do Adolescente/psicologia , Fumar Cigarros/prevenção & controle , Educação em Saúde/métodos , Fumar Maconha/prevenção & controle , Jogos de Vídeo/psicologia , Adolescente , Criança , Comportamento do Consumidor/estatística & dados numéricos , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Estudo de Prova de Conceito , AutoeficáciaRESUMO
BACKGROUND: Human immunodeficiency virus (HIV) disproportionately impacts minority youth. Interventions to decrease HIV sexual risk are needed. OBJECTIVE: We hypothesized that an engaging theory-based digital health intervention in the form of an interactive video game would improve sexual health outcomes in adolescents. METHODS: Participants aged 11 to 14 years from 12 community afterschool, school, and summer programs were randomized 1:1 to play up to 16 hours of an experimental video game or control video games over 6 weeks. Assessments were conducted at 6 weeks and at 3, 6, and 12 months. Primary outcome was delay of initiation of vaginal/anal intercourse. Secondary outcomes included sexual health attitudes, knowledge, and intentions. We examined outcomes by gender and age. RESULTS: A total of 333 participants were randomized to play the intervention (n=166) or control games (n=167): 295 (88.6%) were racial/ethnic minorities, 177 (53.2%) were boys, and the mean age was 12.9 (1.1) years. At 12 months, for the 258 (84.6%) participants with available data, 94.6% (122/129) in the intervention group versus 95.4% (123/129) in the control group delayed initiation of intercourse (relative risk=0.99, 95% CI 0.94-1.05, P=.77). Over 12 months, the intervention group demonstrated improved sexual health attitudes overall compared to the control group (least squares means [LS means] difference 0.37, 95% CI 0.01-0.72, P=.04). This improvement was observed in boys (LS means difference 0.67, P=.008), but not girls (LS means difference 0.06, P=.81), and in younger (LS means difference 0.71, P=.005), but not older participants (LS means difference 0.03, P=.92). The intervention group also demonstrated increased sexual health knowledge overall (LS means difference 1.13, 95% CI 0.64-1.61, P<.001), in girls (LS means difference 1.16, P=.001), boys (LS means difference 1.10, P=.001), younger (LS means difference 1.18, P=.001), and older (LS means difference=1.08, P=.002) participants. There were no differences in intentions to delay the initiation of intercourse between the two groups (LS means difference 0.10, P=.56). CONCLUSIONS: An interactive video game intervention improves sexual health attitudes and knowledge in minority adolescents for at least 12 months. TRIAL REGISTRATION: Clinicaltrials.gov NCT01666496; https://clinicaltrials.gov/ct2/show/NCT01666496 (Archived by WebCite at http://www.webcitation.org/6syumc9C0).
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Comportamento Sexual/psicologia , Jogos de Vídeo/psicologia , Adolescente , Criança , Feminino , Humanos , Masculino , Grupos Minoritários , Comportamento de Redução do RiscoRESUMO
BACKGROUND: The Patient Protection and Affordable Care Act encourages healthcare systems to track quality-of-care measures; little is known about their impact on mortality rates. The objective of this study was to assess associations between HIV quality of care and mortality rates. METHODS: A longitudinal survival analysis of the Veterans Aging Cohort Study included 3038 human immunodeficiency virus (HIV)-infected patients enrolled between June 2002 and July 2008. The independent variable was receipt of ≥80% of 9 HIV quality indicators (QIs) abstracted from medical records in the 12 months after enrollment. Overall mortality rates through 2014 were assessed from the Veterans Health Administration, Medicare, and Social Security National Death Index records. We assessed associations between receiving ≥80% of HIV QIs and mortality rates using Kaplan-Meier survival analysis and adjusted Cox proportional hazards models. Results were stratified by unhealthy alcohol and illicit drug use. RESULTS: The majority of participants were male (97.5%) and black (66.8%), with a mean (standard deviation) age of 49.0 (8.8) years. Overall, 25.9% reported past-year unhealthy alcohol use and 28.4% reported past-year illicit drug use. During 24 805 person-years of follow-up (mean [standard deviation], 8.2 [3.3] years), those who received ≥80% of QIs experienced lower age-adjusted mortality rates (adjusted hazard ratio, 0.75; 95% confidence interval, .65-.86). Adjustment for disease severity attenuated the association. CONCLUSIONS: Receipt of ≥80% of select HIV QIs is associated with improved survival in a sample of predominantly male, black, HIV-infected patients but was insufficient to overcome adjustment for disease severity. Interventions to ensure high-quality care and address underlying chronic illness may improve survival in HIV-infected patients.
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Infecções por HIV/mortalidade , Qualidade da Assistência à Saúde , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Mortalidade , Análise de Sobrevida , VeteranosRESUMO
Harms of opioid analgesics, especially high-dose therapy among individuals with comorbidities and older age, are increasingly recognized. However, trends in opioid receipt among HIV-infected patients are not well characterized. We examined trends, from 1999 to 2010, in any and high-dose (≥120 mg/day) opioid receipt among patients with and without HIV, by age strata, controlling for demographic and clinical correlates. Of 127,216 patients, 64 % received at least one opioid prescription. Opioid receipt increased substantially among HIV-infected and uninfected patients over the study; high-dose therapy was more prevalent among HIV-infected patients. Trends in high-dose receipt stratified by three age groups revealed an increasing trend in each age strata, higher among HIV-infected patients. Correlates of any opioid receipt included HIV, PTSD and major depression. Correlates of high-dose receipt included HIV, PTSD, major depression and drug use disorders. These findings suggest a need for appropriate balance of risks and benefits, especially as these populations age.
Assuntos
Analgésicos Opioides/administração & dosagem , Dor Crônica/tratamento farmacológico , Prescrições de Medicamentos/estatística & dados numéricos , Infecções por HIV/complicações , Manejo da Dor/tendências , Veteranos/estatística & dados numéricos , Dor Aguda/tratamento farmacológico , Dor Aguda/epidemiologia , Dor Aguda/etiologia , Adulto , Idoso , Analgésicos Opioides/uso terapêutico , Dor Crônica/epidemiologia , Dor Crônica/etiologia , Estudos de Coortes , Estudos Transversais , Esquema de Medicação , Feminino , Infecções por HIV/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Dor/tratamento farmacológico , Dor/epidemiologia , Dor/etiologia , Manejo da Dor/métodos , Manejo da Dor/estatística & dados numéricos , Prevalência , Fatores Sexuais , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: To address the need for risk behavior reduction and human immunodeficiency virus prevention interventions that capture adolescents "where they live," we created a tablet-based videogame to teach skills and knowledge and influence psychosocial antecedents for decreasing risk and preventing human immunodeficiency virus infection in minority youth in schools, after-school programs, and summer camps. METHODS: We developed PlayForward: Elm City Stories over a 2-year period, working with researchers, commercial game designers, and staff and teens from community programs. The videogame PlayForward provides an interactive world where players, using an avatar, "travel" through time, facing challenges such as peer pressure to drink alcohol or engage in risky sexual behaviors. Players experience how their choices affect their future and then are able to go back in time and change their choices, creating different outcomes. A randomized controlled trial was designed to evaluate the efficacy of PlayForward. Participants were randomly assigned to play PlayForward or a set of attention/time control games on a tablet at their community-based program. Assessment data were collected during face-to-face study visits and entered into a web-based platform and unique real-time "in-game" PlayForward data were collected as players engaged in the game. The innovative methods of this randomized controlled trial are described. We highlight the logistical issues of conducting a large-scale trial using mobile technology such as the iPad(®), and collecting, transferring, and storing large amounts of in-game data. We outline the methods used to analyze the in-game data alone and in conjunction with standardized assessment data to establish correlations between behaviors during gameplay and those reported in real life. We also describe the use of the in-game data as a measure of fidelity to the intervention. RESULTS: In total, 333 boys and girls, aged 11-14 years, were randomized over a 14-month period: 166 were assigned to play PlayForward and 167 to play the control games. To date (as of 1 March 2016), 18 have withdrawn from the study; the following have completed the protocol-defined assessments: 6 weeks: 271 (83%), 3 months: 269 (84%), 6 months: 254 (79%), 12 months: 259 (82%), and 24 months: is ongoing with 152 having completed out of the 199 participants (76%) who were eligible to date (assessment windows were still open). CONCLUSION: Videogames can be developed to address complex behaviors and can be subject to empiric testing using community-based randomized controlled trials. Although mobile technologies pose challenges in their use as interventions and in the collection and storage of data they produce, they provide unique opportunities as new sources of potentially valid data and novel methods to measure the fidelity of digitally delivered behavioral interventions.
Assuntos
Infecções por HIV/prevenção & controle , Projetos de Pesquisa , Comportamento de Redução do Risco , Jogos de Vídeo , Adolescente , Consumo de Bebidas Alcoólicas/prevenção & controle , Criança , Computadores de Mão , Interpretação Estatística de Dados , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Grupos Minoritários , Influência dos Pares , RiscoRESUMO
BACKGROUND: Videogame interventions are becoming increasingly popular as a means to engage people in behavioral interventions; however, strategies for examining data from such interventions have not been developed. OBJECTIVE: The objective of this study was to describe how a technology-based intervention can yield meaningful, objective evidence of intervention exposure within a behavioral intervention. This study demonstrates the analysis of automatic log files, created by software from a videogame intervention, that catalog game play and, as proof of concept, the association of these data with changes in substance use knowledge as documented with standardized assessments. METHODS: We analyzed 3- and 6-month follow-up data from 166 participants enrolled in a randomized controlled trial evaluating a videogame intervention, PlayForward: Elm City Stories (PlayForward). PlayForward is a videogame developed as a risk reduction and prevention program targeting HIV risk behaviors (substance use and sex) in young minority adolescents. Log files were analyzed to extract the total amount of time spent playing the videogame intervention and the total number of game levels completed and beaten by each player. RESULTS: Completing and beating more of the game levels, and not total game play time, was related to higher substance use knowledge scores at the 3- (P=.001) and 6-month (P=.001) follow-ups. CONCLUSIONS: Our findings highlight the potential contributions a videogame intervention can make to the study of health behavior change. Specifically, the use of objective data collected during game play can address challenges in traditional human-delivered behavioral interventions. TRIAL REGISTRATION: Clinicaltrials.gov NCT01666496; https://clinicaltrials.gov/ct2/show/NCT01666496 (Archived by WebCite at http://www.webcitation.org/6cV9fxsOg).
Assuntos
Intervenção Educacional Precoce/métodos , Transtornos Relacionados ao Uso de Substâncias , Telemedicina/métodos , Jogos de Vídeo/ética , Adolescente , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Comportamento de Redução do RiscoRESUMO
Adults who abuse substances are at increased risk for contracting sexually transmitted infections, including HIV. Within this population, sexual risk behaviors have been associated with increased impulsivity. Studies in non-clinical populations showing gender-related differences in sexual decision-making and casual sexual partnering suggest impulsivity has a greater influence on men than women, but these differences have not been documented in substance-using patients. In a sample of 89 adults with recent cocaine use and receiving outpatient psychiatric treatment, we tested the hypothesis that gender moderates the effect of impulsivity on sexual risk-taking. Using logistic regression modeling, we tested the main and gender-moderated effects of task-related impulsivity on the probability of having a casual sexual partner and multiple sexual partners. Results confirmed a significant gender-by-impulsivity interaction; men who were more impulsive on a continuous performance task had significantly higher rates of sexual risk-taking than less impulsive men, but women's impulsivity was unrelated to these outcomes. Impulsive men were over three times as likely as less impulsive men to have a recent casual partner. Implications of these results and suggestions for future research are discussed.
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Few studies have explored the application of message framing to promote health behaviors in adolescents. In this exploratory study, we examined young adolescents' selection of gain- versus loss-framed images and messages when designing an HIV-prevention intervention to promote delayed sexual initiation. Twenty-six adolescents (aged 10-14 years) participated in six focus groups and created and discussed posters to persuade their peers to delay the initiation of sexual activity. Focus groups were audio-recorded and transcribed. A five-person multidisciplinary team analyzed the posters and focus group transcripts using thematic analysis. The majority of the posters (18/26, 69%) contained both gain- and loss-framed content. Of the 93/170 (56%) images and messages with framing, similar proportions were gain- (48/93, 52%) and loss-framed (45/93, 48%). Most gain-framed content (23/48, 48%) focused on academic achievement, whereas loss-framed content focused on pregnancy (20/45, 44%) and HIV/AIDS (14/45, 31%). These preliminary data suggest that young adolescents may prefer a combination of gain- and loss-framing in health materials to promote reduction in sexual risk behaviors.
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Promoção da Saúde/métodos , Sexo sem Proteção/prevenção & controle , Adolescente , Criança , Feminino , Grupos Focais , Infecções por HIV/prevenção & controle , Humanos , Masculino , Projetos Piloto , Gravidez , Gravidez na Adolescência/prevenção & controle , Comportamento Sexual/psicologiaRESUMO
Health interventions are increasingly focused on young adolescents, and as a result, discussions with this population have become a popular method in qualitative research. Traditional methods used to engage adults in discussions do not translate well to this population, who may have difficulty conceptualizing abstract thoughts and opinions and communicating them to others. As part of a larger project to develop and evaluate a video game for risk reduction and HIV prevention in young adolescents, we were seeking information and ideas from the priority audience that would help us create authentic story lines and character development in the video game. To accomplish this authenticity, we conducted in-depth interviews and focus groups with young adolescents aged 10 to 15 years and employed three novel methods: Storytelling Using Graphic Illustration, My Life, and Photo Feedback Project. These methods helped provide a thorough understanding of the adolescents' experiences and perspectives regarding their environment and future aspirations, which we translated into active components of the video game intervention. This article describes the processes we used and the valuable data we generated using these three engaging methods. These three activities are effective tools for eliciting meaningful data from young adolescents for the development of health interventions.
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Serviços de Saúde do Adolescente/organização & administração , Coleta de Dados/métodos , Promoção da Saúde/organização & administração , Jogos de Vídeo , Adolescente , Criança , Feminino , Grupos Focais , Humanos , Entrevistas como Assunto , Masculino , Pesquisa QualitativaRESUMO
PURPOSE: Adolescents are the age group that is least likely to know their HIV status and may unknowingly transmit the virus to others. A randomized controlled trial was conducted to evaluate the impact of the original video game intervention, PlayTest!, on behavioral antecedents for HIV testing and counseling (HTC). METHODS: Participants (N = 287 adolescents) were recruited between 2018 and 2020 and were 48% female, aged 14-18 years (mean age = 15.4 years), and 76% racial minorities. Participants were randomized 1:1 and assigned to either play PlayTest! or a set of control games, â¼one session per week for an hour per session over 4-6 weeks (gameplay) after school. The primary outcome measure was participants' attitudes around HTC at 6 months, with intentions, knowledge, self-efficacy, and behaviors assessed as secondary outcomes. RESULTS: Two hundred and ninety-six participants were enrolled/randomized; nine were withdrawn due to incomplete parental consent forms, leaving 287 participants: 145 were randomized to PlayTest! and 142 to the control condition. Mixed between-within subjects ANOVAs assessed the impact of the study conditions on outcomes. Improvements were seen in the PlayTest! group in HTC attitudes (p < .001), intentions (p < .001), knowledge (p < .001), and self-efficacy (p = .002) at all time-points. At 6 months, for those who had access to HTC (N = 134; prior to COVID-19) and for those who did not have access to HTC (N = 261; during COVID-19), there were no differences in self-reported HTC between the two groups (p = .289 and p = .074, respectively). DISCUSSION: PlayTest! impacted important behavioral antecedents related to HTC and has the potential to broadly increase HTC rates in adolescents.
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COVID-19 , Infecções por HIV , Jogos de Vídeo , Adolescente , Humanos , Feminino , Masculino , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Aconselhamento , Teste de HIVRESUMO
Games offer advantages over traditional methods of assessing cognitive function among children and adolescents. However, the validity of game-based assessments has not been systematically evaluated. We conducted a systematic review and meta-analysis to assess the validity of game-based assessments measuring cognitive function among children and adolescents. We systematically searched several databases using pre-defined inclusion criteria. For papers that met the criteria, we extracted and analyzed the cognitive functions measured by each study, the correlation coefficients between game-based and traditional assessments, and factors that could influence the validity of game-based assessments. Our review identified 19 articles featuring 20 studies, 18 games, and 378 unique correlations between game-based and traditional assessments of cognitive function. Game-based assessments yielded significant correlations (n=282, 75%) with traditional assessments, over half of which were in the low to medium range in strength (r=0.3-0.69, n=227, 80%). Factors related to the child, such as age, gender, and prior gaming experience, may influence the validity of game-based assessments by modifying performance on game-based assessments. In addition, we found that game-based assessments that measured cognitive functions across more than one neurocognitive domain and used a prediction model for scoring were more likely to yield significant correlations. In contrast, including a narrative storyline in a game-based assessment was less likely to yield significant correlations. Most studies were of good quality, although the lack of sample size justification was a limiting factor. Further research is needed to elucidate the influence of identified factors on the validity of game-based assessment to justify the wide adoption of game-based assessments of cognitive function among children and adolescents.
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Cognição , Narração , Criança , Adolescente , HumanosRESUMO
Adolescents who engage in non-opioid substance misuse and/or experience mental health symptoms are at greater risk of misusing opioids and/or developing opioid use disorder. Adolescence is a critical developmental period to both prevent the initiation of opioid misuse and target mental health. To date, there are no digital health games targeting both conditions. We describe the protocol for a randomized controlled trial designed to assess the efficacy of an original digital health game, PlaySmart. Five hundred and thirty-two adolescents aged 16-19 years old, who are at greater risk for initiating opioid misuse are recruited from 10 Connecticut school-based health sites. Participants are randomized to PlaySmart or a set of time/attention control videogames. Randomization was stratified by sex at birth and school grade. Participants play their assigned game or games for up to six weeks (300 minutes) and complete assessment questions over a 12-month period (baseline, post-gameplay, 3, 6, and 12 months). The primary outcome is perception of risk of harm of opioid misuse at 3 months. Secondary outcome measures specific to opioid misuse include intentions, self-efficacy, attitudes, knowledge, and perceived norms. Mental health outcomes include measures of depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), help-seeking behaviors, stigma, measures of self-regulation, self-efficacy to seek professional help for mental health, and knowledge around coping skills. PlaySmart has the potential to significantly reduce the risk of initiation of opioid misuse, improve mental health outcomes, and given its high levels of engagement and accessibility, holds the promise for extensive reach, scale, and impact for adolescents. Trial registration: ClinicalTrials.gov: NCT04941950. Registered on 23 June 2021.