Feasibility of Peer-mentor Delivered Substance Use Brief Intervention for Adolescents in Kenya

Substance Use Clinical Trial

Official title:

A Pilot Study to Evaluate the Feasibility & Acceptability of a Peer-mentor Delivered Substance Use Screening and Brief Intervention for Adolescents in Kenya

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545904
• Other study ID #: MoiU6
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2022
• Source: Moi University
• Contact: FLORENCE M. JAGUGA, MMED
• Phone: +254726626391
• Email: flokemboi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Substance use brief intervention (BI)
The BI will be delivered in a single session (20-30 minutes) using motivational interviewing techniques and the FRAMES model i.e.(i) providing feedback on screening results (ii) ensuring responsibility on the part of the adolescents (iii) giving clear advice to stop/cut down (iv) giving menu of options (alternative healthy behaviors to engage in) (v) expressing empathy, and (vi) encouraging self-efficacy (15). The BI will be delivered for the highest scoring substance or the one the adolescent identifies as the most problematic.
• substance use education intervention
This intervention will entail review of material in the NACADA substance use education manual for adolescents, and will be followed by a question and answer session. The manual contains summarized and simple information on the harms and myths related to alcohol, tobacco, cannabis, prescription medication and khat use, substances. This education intervention will be delivered over a single 20-30 minute session by a counselor stationed at Rafiki clinic.

Locations

Country	Name	City	State
Kenya	Florence Jaguga	Eldoret	RIFT Valley

Sponsors (2)

Lead Sponsor	Collaborator
Moi University	Indiana University

Country where clinical trial is conducted

Kenya, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use scores (measured using ASSIST-Y)	The researchers will compare the changes in the mean ASSIST-Y scores between the two intervention and control arms	Change from baseline to 3 months post-intervention.
Secondary	Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool)	The researchers will compare the changes in the mean WHO-QOL scores between the intervention and control arms	Change from baseline to 3 months post-intervention.
Secondary	Fidelity to the intervention assessed using a researcher designed rating scale	Fidelity checklists will be developed based on key elements of the intervention. Items will be rated by the SBI trainers on a 3-point scale.	until completion of participant recruitment and follow-up, an average of 3 months
Secondary	Study Participation Rate	Number of participants who consent to take part in the study divided by the number of eligible patients. The researchers will also document reasons for refusal to participate in the study. Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those who eligibility meet criteria consent to participate	until completion of participant recruitment and follow-up, an average of 3 months
Secondary	Proportion of participants meeting inclusion criteria who get excluded	Number of participants excluded divided by number meeting inclusion criteria. The researchers will document reasons for exclusion; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those meeting inclusion criteria are not excluded	until completion of participant recruitment and follow-up, an average of 3 months
Secondary	Proportion of participants willing to be randomized	Number of participants consenting to participate divided by number willing to be randomized to either study arm; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those consenting are willing to be randomized to either study arm	until completion of participant recruitment and follow-up, an average of 3 months
Secondary	Study Completion Rate	Number of participants who complete both the baseline and month 3 assessments/intervention divided by the number of participants enrolled in each study arm; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% complete both baseline and month 3 assessments	Baseline, month 3
Secondary	Participant Burden	Time required to complete data collection at each assessment time point. Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of participants complete study assessments and the SBI in less than 90 minutes at baseline; and study assessments in less than 60 minutes at month 3	Baseline, month 3
Secondary	Data Completeness	Percentage of questionnaires/study measures completed; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those who enroll will complete at least 80% of study questionnaires/measures	Baseline, month 3