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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05545904
Recruitment Status : Not yet recruiting
First Posted : September 19, 2022
Last Update Posted : September 19, 2022
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Moi University

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.

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Substance use brief intervention (BI) Behavioral: substance use education intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
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
Estimated Study Start Date : January 15, 2023
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Arm Intervention/treatment
Experimental: Intervention arm
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.
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.

Placebo Comparator: Control arm
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in substance use scores (measured using ASSIST-Y) [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool) [ Time Frame: Change from baseline to 3 months post-intervention. ]
    The researchers will compare the changes in the mean WHO-QOL scores between the intervention and control arms

  2. Fidelity to the intervention assessed using a researcher designed rating scale [ Time Frame: until completion of participant recruitment and follow-up, an average of 3 months ]
    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.

  3. Study Participation Rate [ Time Frame: until completion of participant recruitment and follow-up, an average of 3 months ]
    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

  4. Proportion of participants meeting inclusion criteria who get excluded [ Time Frame: until completion of participant recruitment and follow-up, an average of 3 months ]
    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

  5. Proportion of participants willing to be randomized [ Time Frame: until completion of participant recruitment and follow-up, an average of 3 months ]
    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

  6. Study Completion Rate [ Time Frame: Baseline, month 3 ]
    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

  7. Participant Burden [ Time Frame: Baseline, month 3 ]
    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

  8. Data Completeness [ Time Frame: Baseline, month 3 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05545904


Contacts
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Contact: FLORENCE M. JAGUGA, MMED +254726626391 flokemboi@gmail.com
Contact: MATTHEW AALSMA, PHD maalsma@iu.edu

Locations
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Kenya
Florence Jaguga
Eldoret, RIFT Valley, Kenya, 30100
Sponsors and Collaborators
Moi University
Indiana University
Investigators
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Principal Investigator: FLORENCE M, JAGUGA, MMED MOI TEACHING & REFERRAL HOSPITAL
Publications:
National Institute of Drug Abuse. Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide: Introduction | NIDA [Internet]. [cited 2022 Feb 27]. Available from: https://nida.nih.gov/publications/principles-adolescent-substance-use-disorder-treatment-research-based-guide/introduction
World Health Organisation. Brief Intervention. A Manual For Use In A Manual For Use In A Manual For Use In A Manual For Use In Primary Care Primary. 2003.
United Nations Office on drugs and Crime. International standards on drug use prevention - second updated edition [Internet]. 2018. 58 p. Available from: http://www.unodc.org/documents/prevention/standards_180412.pdf
Osborn TL, Venturo-Conerly KE, Wasil AR, Schleider JL, Weisz JR. Depression and Anxiety Symptoms, Social Support, and Demographic Factors Among Kenyan High School Students. J Child Fam Stud [Internet]. 2020 May 1 [cited 2020 Oct 22];29(5):1432-43. Available from: https://link.springer.com/article/10.1007/s10826-019-01646-8
World Health Organization (WHO). Optimal Mix of Health Services. 2007; Available from: https://www.who.int/mental_health/policy/services/2_Optimal Mix of Services_Infosheet.pdf

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Responsible Party: Moi University
ClinicalTrials.gov Identifier: NCT05545904    
Other Study ID Numbers: MoiU6
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders