A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tyra Boomer
- 入组人数
- 533
- 试验地点
- 30
- 主要终点
- Perception of Risk
研究概览
简要总结
The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.
详细描述
This study's specific aims are to:
Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •1) preferably be enrolled in their high school's School-Based Health Center;
- •2) report NOT having engaged in any prior opioid misuse;
- •3) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
- •4) be willing to sit for 60 minutes/session to play the game;
- •5) be able to provide assent/parental/guardian consent (if under age 18).
排除标准
- •Failure to meet any of the inclusion criteria.
研究组 & 干预措施
Control Game
Control video game intervention.
干预措施: Video Game Control (Other)
PlaySmart
Video game intervention.
干预措施: PlaySmart (Behavioral)
结局指标
主要结局
Perception of Risk
时间窗: 3 months
Perceived risk was measured by the question, "How much do you think people risk harming themselves (physically or in other ways), if they..." try or use a drug. For example, "...try marijuana once or twice." The answer categories are "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Parallel questions refer to using the same drug "occasionally" and "regularly." It is an 8 item, 4-point Likert scale. Total score range from 0-24. Higher scores mean greater perception of risk.
Change in Perception of Risk
时间窗: Baseline, 6 weeks, 3, 6, and 12 months
Perceived risk was measured by the question, "How much do you think people risk harming themselves (physically or in other ways), if they..." try or use a drug. For example, "...try marijuana once or twice." The answer categories are "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Parallel questions refer to using the same drug "occasionally" and "regularly." It is an 8 item, 4-point Likert scale. Total score range from 0-24. Higher scores mean greater perception of risk. This outcome will be measured at baseline, after 6 weeks of gameplay, and at 3, 6, and 12 months after baseline.
Proportion Reporting 'Great Perceived Risk of Harm' From Opioid Misuse
时间窗: 3 months
Perceived risk of harm from opioid misuse was assessed using eight items adapted from the U.S. Monitoring the Future survey. Five items assess perceived risk associated with heroin use and three items assess perceived risk associated with prescription opioid misuse. Participants were asked how much risk people have of harming themselves (physically or in other ways) if they use the drug once or twice, occasionally, or regularly. Response options were "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Items were scored from 1 to 4 (no risk = 1, slight risk = 2, moderate risk = 3, great risk = 4). Item scores were summed to create a total perceived risk score (range 8-32), with scores \<32 indicating "no great perceived risk of harm" and scores=32 indicating "great perceived risk of harm." The primary outcome was defined as the proportion of participants who reported "great perceived risk of harm" from opioids (score=32) at 3 months.
次要结局
- Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions)(Baseline)
- Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Intentions to Misuse Opioids (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Self Efficacy for Refusing Opioids (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Attitudes to Misuse Opioids (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Involvement with Legally Manufactured Opioids (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Perceived Norms About Opioid Misuse (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Beliefs About Psychological Services (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Involvement with Marijuana (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Decision-Making Skills (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Help Seeking Behavior (General) (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Gameplay Usability (p2P Lab Questions)(6 weeks)
- Mental Health (Depression - PHQ-8) (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Help-Seeking Behavior (Past) (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Gameplay Engagement (p2P Lab Questions)(6 weeks)
- Self-Efficacy (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Experience with Pain (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Self-Stigma of Seeking Help Scale (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Gameplay Experience (p2P Lab Questions)(6 weeks)
- Involvement with Illegally Manufactured Opioids (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Involvement with Alcohol (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Intentions to Misuse Opioids (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Self Efficacy for Refusing Opioids (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Knowledge About Opioid Misuse and Its Risks (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Positive Attitudes Toward Opioid Misuse (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
- Negative Attitudes Toward Opioid Misuse (p2P Lab Questions)(Baseline, 6 weeks, 3, 6, and 12 months)
研究者
Tyra Boomer
Deputy Director, play2PREVENT Lab
Trustees of Dartmouth College