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

Primary Purpose

Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Substance use brief intervention (BI)
substance use education intervention
Sponsored by
Moi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Florence Jaguga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention arm

Control arm

Arm Description

Participants randomized to the intervention arm will undergo a substance use screening and brief intervention delivered by the peer-mentors. Screening will be performed using the ASSIST-Y (28). The brief intervention will be delivered in a single session (20-30 minutes) using 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.

Participants assigned to the control arm will participate in a 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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
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
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
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
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

Full Information

First Posted
September 11, 2022
Last Updated
September 15, 2022
Sponsor
Moi University
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05545904
Brief Title
Feasibility of Peer-mentor Delivered Substance Use Brief Intervention for Adolescents in Kenya
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moi University
Collaborators
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Following enrollment and baseline assessment, participants will be randomized to one of the two study groups (allocation ratio: 1:1) - SBI intervention or the control condition (an education session on harms of substance use.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants randomized to the intervention arm will undergo a substance use screening and brief intervention delivered by the peer-mentors. Screening will be performed using the ASSIST-Y (28). The brief intervention will be delivered in a single session (20-30 minutes) using 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.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Participants assigned to the control arm will participate in a 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.
Intervention Type
Behavioral
Intervention Name(s)
Substance use brief intervention (BI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
substance use education intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in substance use scores (measured using ASSIST-Y)
Description
The researchers will compare the changes in the mean ASSIST-Y scores between the two intervention and control arms
Time Frame
Change from baseline to 3 months post-intervention.
Secondary Outcome Measure Information:
Title
Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool)
Description
The researchers will compare the changes in the mean WHO-QOL scores between the intervention and control arms
Time Frame
Change from baseline to 3 months post-intervention.
Title
Fidelity to the intervention assessed using a researcher designed rating scale
Description
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.
Time Frame
until completion of participant recruitment and follow-up, an average of 3 months
Title
Study Participation Rate
Description
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
Time Frame
until completion of participant recruitment and follow-up, an average of 3 months
Title
Proportion of participants meeting inclusion criteria who get excluded
Description
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
Time Frame
until completion of participant recruitment and follow-up, an average of 3 months
Title
Proportion of participants willing to be randomized
Description
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
Time Frame
until completion of participant recruitment and follow-up, an average of 3 months
Title
Study Completion Rate
Description
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
Time Frame
Baseline, month 3
Title
Participant Burden
Description
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
Time Frame
Baseline, month 3
Title
Data Completeness
Description
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
Time Frame
Baseline, month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FLORENCE M. JAGUGA, MMED
Phone
+254726626391
Email
flokemboi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
MATTHEW AALSMA, PHD
Email
maalsma@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FLORENCE M, JAGUGA, MMED
Organizational Affiliation
MOI TEACHING & REFERRAL HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florence Jaguga
City
Eldoret
State/Province
RIFT Valley
ZIP/Postal Code
30100
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
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Feasibility of Peer-mentor Delivered Substance Use Brief Intervention for Adolescents in Kenya

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