Mindfulness Mobile App to Reduce Adolescent Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- Number of Participants With Marijuana Use
研究概览
简要总结
Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide. The proposed Phase II project aims to develop and test the efficacy of a mobile app, called Qlarity, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Qlarity app is based on the primary substance use cessation components tested in our previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation; it applies a mindfulness approach as the guiding framework for the intervention.
详细描述
There is growing evidence that interventions based on mindfulness have been an efficacious intervention for a variety of problems, including substance use among adolescents. We propose to adapt and test the feasibility and efficacy of a smart phone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use through the development of stress reduction, emotion regulation, and mindfulness skills. During the development process, 20 high-risk adolescents will be recruited for participation in focus groups and usability testing of early versions of the app; their initial reactions to content and functionality will help guide final iterations. Qlarity is a twelve module program, and each module consists of a teaching component and a practice component. Modules take 5 minutes or less to complete. Module topics include developing an awareness of mind and body states, mindful decision making, and maintaining sobriety.
In this study, the Qlarity app will be evaluated with 400 high risk adolescents that are involved in the juvenile justice system; the first 20 adolescents will be involved in the development process and the remaining 380 participants will be randomly and equally assigned to the Qlarity condition (n = 190) or the Department of Youth Services standard treatment condition (n = 190). Youth will be assessed at baseline and will be instructed to attempt to reduce substance use with a target quit date of 28 days in the future. The Qlarity group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month follow-ups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Qlarity group will also be asked for their thoughts and opinions on the app. Biochemical verification of self-reported substance use, a urine sample, will be collected at each interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any gender, age 13-18
- •recent involvement with juvenile justice system
- •documented substance use
- •English speaking
- •living in the community (e.g., with biological/adoptive/foster parents)
排除标准
- •non-English speaking
结局指标
主要结局
Number of Participants With Marijuana Use
时间窗: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect marijuana in a urine sample.
Number of Participants With Prescribed Drugs Use
时间窗: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect prescribed drugs in a urine sample.
Number of Participants With Hard Drug Use
时间窗: Baseline, 3 months
An EZ Split Key 10 panel cup was used to detect hard drugs in a urine sample.
Change in Adolescent Use of Cigarettes
时间窗: Baseline, 1 month, 3 months
Change in nicotine use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Alcohol
时间窗: Baseline, 1 month, 3 months
Change in alcohol use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Marijuana
时间窗: Baseline, 1 month, 3 months
Change in marijuana use (frequency of use and amount consumed) as measured by Youth Substance Use Interview
Change in Adolescent Use of Other Recreational Substances
时间窗: Baseline, 1 month, 3 months
Change in use of hard drugs as measured by the Youth Substance Use Interview
Change in Ability to Limit Substance Use
时间窗: Baseline, 1 month, 3 months
Self-efficacy for limiting substance use consists of 6 items that assess the ability to abstain from drug use. Response options range from 0 = cannot do at all to 10 = certainly can do. A sum score was computed and thus, values can range between 0 and 60. Higher scores indicate greater ability to abstain
Change in Emotion Regulation
时间窗: Baseline, 1 month, 3 months
Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Emotional regulation was assessed with a 5-point response option (1 = almost never, 5 = almost always). A sum score was computed and thus, values can range between 1 and 55. A higher score indicates greater levels of emotional regulation.
Change in Mindfulness Behavior - Observing Subscale
时间窗: Baseline, 1 month, 3 months
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Change in Mindfulness Behavior - Describing Subscale
时间窗: Baseline, 1 month, 3 months
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Change in Mindfulness Behavior - Acting With Awareness Subscale
时间窗: Baseline, 1 month, 2 months
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Change in Mindfulness Behavior - Non-judging of Inner Experience Subscale
时间窗: Baseline, 1 month, 3 months
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Change in Mindfulness Behavior - Non-reactivity to Inner Experience Subscale
时间窗: Baseline, 1 month, 3 months
Mindfulness is measured by the Five Facet Mindfulness Questionnaire. Mindfulness was assessed with a 5-point response option (1 = never or very rarely true, 5 = every often or always true) and sum scores were computed for each subscale. Subscales include observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Score could range from 8 to 40 for all subscales other than reactivity to inner experience which could range from 7 to 35. A higher score indicates greater levels of mindfulness.
Change in Attitude Toward Substance Use - Beliefs and Consequences Subscale
时间窗: Baseline, 1 month, 3 months
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
Change in Attitudes Towards Substance Use - Lifestyle and Value Incompatibility Subscale
时间窗: Baseline, 1 month, 3 months
Change in attitude related to drug use is measured with Adolescent Attitudes toward Substance Use. Subscales are (1) Beliefs and Consequences (9 items) and (2) Lifestyle and Value incompatibility (5 items). Response options were 0 to 10. Standardized scores were computed and values could range from -2.0 to 2.0. Higher scores represent more prosocial attitudes.
次要结局
未报告次要终点