A Pilot Study to Evaluate the Feasibility & Acceptability of a Peer-mentor Delivered Substance Use Screening and Brief Intervention for Adolescents in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in substance use scores (measured using ASSIST-Y)
研究概览
简要总结
Adolescent substance use is prevalent in Kenya and in the US, and is associated with significant negative health and social outcomes. Unfortunately adolescents in both regions have limited access to substance use treatment because services are costly and scarce. The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use brief intervention among adolescents attending an out-patient clinic in Kenya.
详细描述
Background: Adolescent substance use is prevalent in Kenya and in the US, and is associated with significant negative health and social outcomes. Unfortunately adolescents in both regions have limited access to substance use treatment because services are costly and scarce. Substance use screening and brief Intervention (SBI) delivered in primary health care by peer-mentors, represents a promising strategy for overcoming these barriers to substance use treatment for adolescents.
Objective: The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use SBI among adolescents attending an out-patient clinic in Kenya.
Design: The study will use both qualitative and quantitative methods to meet its objectives
Intervention: SBI includes a single session of screening using the Alcohol, Smoking & Substance Use Involvement Screening Test for Youth questionnaire (ASSIST-Y), followed by a brief intervention (20-30 minutes of motivational interviewing) for those with moderate and high risk substance use. Three peers will be trained for five days on how to deliver the SBI. The peer-mentors will receive regular supervision throughout the study implementation process.
Outcomes: SBI feasibility will be defined by the extent to which fidelity to the SBI is maintained and the preliminary effects of the SBI on substance use and quality of life outcomes. SBI acceptability will be evaluated from the perspective of the adolescents using qualitative interviews guided by Sekhon's theoretical framework of acceptability. Feasibility of conducting a future full-scale RCT will be explored by measuring outcomes such as study participation rate, willingness to be randomized, study completion rates and ability to measure effectiveness outcomes.
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
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be adolescents attending the Rafiki clinic, aged 15-24 years and who have moderate or high risk substance use as defined by the Alcohol, Smoking & Substance Use Involvement Screening Test for Youth questionnaire (ASSIST-Y) scores
排除标准
- •The following youth will be excluded: (i) those ill during the appointment (ii) those who decline to assent/consent (iii) those already enrolled in the Fogarty project.
结局指标
主要结局
Change in substance use scores (measured using ASSIST-Y)
时间窗: Change from baseline to 3 months post-intervention.
The researchers will compare the changes in the mean ASSIST-Y scores between the two intervention and control arms
次要结局
- Fidelity to the intervention assessed using a researcher designed rating scale(until completion of participant recruitment and follow-up, an average of 3 months)
- Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool)(Change from baseline to 3 months post-intervention.)
- Participant Burden(Baseline, month 3)
- Study Participation Rate(until completion of participant recruitment and follow-up, an average of 3 months)
- Proportion of participants meeting inclusion criteria who get excluded(until completion of participant recruitment and follow-up, an average of 3 months)
- Proportion of participants willing to be randomized(until completion of participant recruitment and follow-up, an average of 3 months)
- Data Completeness(Baseline, month 3)
- Study Completion Rate(Baseline, month 3)