Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT05545904
Brief Summary:
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.
Detailed Description:
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.
Investigating team and future plans: This study will be conducted by a team including faculty from Moi Teaching and Referral Hospital, faculty from Indiana University, and a team from the National Authority for Campaign Against Alcohol and drug abuse (NACADA). Our team has experience implementing and scaling peer-led substance use SBIs for adolescent populations. If the SBI and its delivery are found to be feasible and acceptable the plan is to partner with the government to conduct a full-scale multi-site RCT in Kenya and Indiana.
Study:
NCT05545904
Study Brief:
Protocol Section:
NCT05545904