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Substance UseNCT05545904

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

A study testing Substance use brief intervention (BI) and substance use education intervention in people with Substance Use, run by Moi University at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use
What is being tested?
Substance use brief intervention (BI) and substance use education intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteKenya
Study dates
15 Jan 2023to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

FLORENCE M. JAGUGA, MMED contact

+254726626391

flokemboi@gmail.com

MATTHEW AALSMA, PHD contact

maalsma@iu.edu

Kenya1 site

  • Florence Jaguga

    Eldoret, RIFT Valley, 30100

Other trials in Kenya

About this study

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

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.

Read the 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.

Conditions
Substance Use
Being tested
Substance use brief intervention (BI), substance use education intervention
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Substance use brief intervention (BI)Behavioural

    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 interventionBehavioural

    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.

Study groups in NCT05545904
Study groupRoleWhat they receive
Intervention armExperimentalParticipants 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.
Receives: Behavioral: Substance use brief intervention (BI)
Control armPlacebo comparatorParticipants 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.
Receives: Behavioral: substance use education intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline to 3 months post-intervention.

Secondary outcomes (8)

  1. 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

    Measured: Change from baseline to 3 months post-intervention.

  2. 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.

    Measured: until completion of participant recruitment and follow-up, an average of 3 months

  3. 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

    Measured: until completion of participant recruitment and follow-up, an average of 3 months

  4. 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

    Measured: until completion of participant recruitment and follow-up, an average of 3 months

  5. 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

    Measured: until completion of participant recruitment and follow-up, an average of 3 months

  6. 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

    Measured: Baseline, month 3

  7. 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

    Measured: Baseline, month 3

  8. 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

    Measured: Baseline, month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start15 Jan 2023 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545904
Sponsor's protocol ID
MoiU6
Status last verified
Sep 2022
First submitted
11 Sep 2022
Last updated
19 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Degenhardt L, Stockings E, Patton G, Hall WD, Lynskey M. The increasing global health priority of substance use in young people. Lancet Psychiatry. 2016 Mar;3(3):251-64. doi: 10.1016/S2215-0366(15)00508-8. Epub 2016 Feb 18.

    PubMed 26905480

  • 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

  • Heradstveit O, Skogen JC, Hetland J, Hysing M. Alcohol and Illicit Drug Use Are Important Factors for School-Related Problems among Adolescents. Front Psychol. 2017 Jun 20;8:1023. doi: 10.3389/fpsyg.2017.01023. eCollection 2017.

    PubMed 28676779

  • Ritchwood TD, Ford H, DeCoster J, Sutton M, Lochman JE. Risky Sexual Behavior and Substance Use among Adolescents: A Meta-analysis. Child Youth Serv Rev. 2015 May;52:74-88. doi: 10.1016/j.childyouth.2015.03.005.

    PubMed 25825550

  • Gaitho D, Kumar M, Wamalwa D, Wambua GN, Nduati R. Understanding mental health difficulties and associated psychosocial outcomes in adolescents in the HIV clinic at Kenyatta National Hospital, Kenya. Ann Gen Psychiatry. 2018 Jul 10;17:29. doi: 10.1186/s12991-018-0200-8. eCollection 2018.

    PubMed 30002721

  • Lisdahl KM, Gilbart ER, Wright NE, Shollenbarger S. Dare to delay? The impacts of adolescent alcohol and marijuana use onset on cognition, brain structure, and function. Front Psychiatry. 2013 Jul 1;4:53. doi: 10.3389/fpsyt.2013.00053. eCollection 2013.

    PubMed 23847550

  • Erskine HE, Moffitt TE, Copeland WE, Costello EJ, Ferrari AJ, Patton G, Degenhardt L, Vos T, Whiteford HA, Scott JG. A heavy burden on young minds: the global burden of mental and substance use disorders in children and youth. Psychol Med. 2015 May;45(7):1551-63. doi: 10.1017/S0033291714002888. Epub 2014 Dec 23.

    PubMed 25534496

  • Richmond-Rakerd LS, Slutske WS, Wood PK. Age of initiation and substance use progression: A multivariate latent growth analysis. Psychol Addict Behav. 2017 Sep;31(6):664-675. doi: 10.1037/adb0000304. Epub 2017 Aug 14.

    PubMed 28805408

  • Zewdu S, Hanlon C, Fekadu A, Medhin G, Teferra S. Treatment gap, help-seeking, stigma and magnitude of alcohol use disorder in rural Ethiopia. Subst Abuse Treat Prev Policy. 2019 Jan 18;14(1):4. doi: 10.1186/s13011-019-0192-7.

    PubMed 30658659

  • Jaguga F, Kwobah E. A review of the public sector substance use disorder treatment and prevention systems in Kenya. Subst Abuse Treat Prev Policy. 2020 Jul 20;15(1):47. doi: 10.1186/s13011-020-00291-5.

    PubMed 32690036

  • Hoeft TJ, Fortney JC, Patel V, Unutzer J. Task-Sharing Approaches to Improve Mental Health Care in Rural and Other Low-Resource Settings: A Systematic Review. J Rural Health. 2018 Dec;34(1):48-62. doi: 10.1111/jrh.12229. Epub 2017 Jan 13.

    PubMed 28084667

  • 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

  • Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.

    PubMed 22566420

  • Winters KC, Lee S, Botzet A, Fahnhorst T, Nicholson A. One-year outcomes and mediators of a brief intervention for drug abusing adolescents. Psychol Addict Behav. 2014 Jun;28(2):464-474. doi: 10.1037/a0035041.

    PubMed 24955669

Questions about this trial

What is this clinical trial studying?

A study testing Substance use brief intervention (BI) and substance use education intervention in people with Substance Use, run by Moi University at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact FLORENCE M. JAGUGA, MMED (+254726626391, flokemboi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in substance use scores (measured using ASSIST-Y) (time frame: Change from baseline to 3 months post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545904, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.

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