跳至主要内容
临床试验/NCT03301012
NCT03301012招募中不适用

Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) Experiment

Chestnut Health Systems3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
3
主要终点
Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)

研究概览

简要总结

At discharge from outpatient treatment, researchers will recruit 300 young adults and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) experimental condition. Participants in the experimental conditions will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile phone metadata, EMA responses, and EMI utilization. The study's primary aim and hypothesis are:

Aim 1: Test the effects of experimental assignment on the frequency of substance use.

H1 Relative to the control group, participants in the experimental group will have lower scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge).

详细描述

At discharge from outpatient treatment, researchers will recruit 300 young adults and randomly assign them to recovery support as usual control condition or the Smartphone Addiction Recovery Coach for Young Adults (SARC-YA) experimental condition. Participants in the experimental conditions will receive a smartphone, a calling/texting/data plan, and the SARC-YA mobile applications for the first 6 months post treatment discharge. Experimental participants will 1) complete a 2-3 minute recovery-focused ecological momentary assessment (EMA) at 5 random times a day, receive feedback on their current answers, and provided access to behavioral charting of their past answers over time; and 2) receive continuous access to a suite of self-initiated ecological momentary interventions (EMI) to support their recovery via tool box of coping tools, apps related to getting support, and apps related to maintaining a healthy lifestyle. Data include standardized assessments, urine tests, mobile phone metadata, EMA responses, and EMI utilization. The study's aims and their associated hypotheses are:

Aim 1: Test the effects of experimental assignment on the frequency of substance use.

H1 Relative to the control group, participants in the experimental group will have lower scores on the quarterly Substance Frequency Scale (3, 6, 9 months post- discharge). Aim 2: Evaluate the extent to which the experimental effects are moderated by baseline substance use frequency. H2 The Substance Frequency Scale Scores at intake will moderate the effects of experimental on the quarterly subsequent Substance Frequency Scale scores. Aim 3: Test the extent to which the frequency of substance use mediates the effects of experimental assignment on other aspects of recovery including SUD symptoms, HIV risk behavior, quality of life, mental wellness, and days of school. H3a Relative to the control group, participants in the experimental group will have better scores on other aspects of recovery (reverse of number of SUD symptoms, reverse of HIV risk behaviors, quality of life, mental wellness, days of school) in the quarterly interviews. H3b Higher Substance Frequency Scale scores (regardless of assignment) in a given quarter will be associated with worse scores on other aspects of recovery in the next quarter. H3c Substance Frequency Scale scores in a given quarter will mediate the impact of the experimental assignment on other aspects of recovery in the next quarter. Aim 4: Within the experimental condition, determine the degree to which EMA responses (e.g., use, withdrawal, craving, negative and positive affect) and EMI utilization predict the duration of abstinence (to be done within experimental condition.) H4a The duration of abstinence will be negatively related to EMA measures of the recency of use, withdrawal, craving, low self-efficacy to resist relapse, increased negative affect, and decreased positive affect. H4b The duration of abstinence will be positively related to immediate and cumulative EMI utilization.

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
None

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • discharge from an adolescent outpatient SUD treatment program to the community;
  • substance use during the 90 days prior to treatment;
  • aged 18 to 26 at the time of discharge;

排除标准

  • inability to read and communicate in English;
  • does NOT reside or plan to stay in Chicago during the next 9 months;

结局指标

主要结局

Change in GAIN's Substance Frequency Scale from baseline to 6 months (effect of providing the intervention)

时间窗: 6 month SFS minus baseline SFS

The GAIN's Substance Frequency Scale (SFS; alpha=.85; test-retest rho=.94) ranges from 0 to 100% and is calculated as the average percent of days in the past 90 that adolescents reported alcohol, cannabis, stimulates, opioids, and other substance use, days of heavy substance use, and days of problems from substance use. Thus it incorporates the frequency of use, range of substances used, amount used, and degree to which use is causing problems.

次要结局

  • Change in GAIN's Substance Frequency Scale from 6 to 9 months (effect of withdrawing the intervention)(9 months SFS minus 6 month SFS)
  • Change in GAIN Substance Disorder Screener (SDScr) from baseline to 6 months(6 month minus baseline)
  • Change in European Quality of Life 5 dimensions (EQ5D) from baseline to 6 months(6 month minus baseline)
  • Change in the days of school from baseline to 6 months(6 month minus baseline)
  • Change in GAIN Risk Behavior Screener (RBScr) from baseline to 6 months(6 month minus baseline)
  • Change in Mental Health Continuum Short Form (MHC-SF) from baseline to 6 months(6 month minus baseline)
  • Duration of abstinence after a given EMA(Measured at 5 random times per day over 6 months in the experimental condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael L. Dennis, Ph.D.

Senior Research Psychologist and GAIN Coordinating Center Director

Chestnut Health Systems

研究点 (3)

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