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, 

References & Publications (35)

Aalsma MC, Aarons GA, Adams ZW, Alton MD, Boustani M, Dir AL, Embi PJ, Grannis S, Hulvershorn LA, Huntsinger D, Lewis CC, Monahan P, Saldana L, Schwartz K, Simon KI, Terry N, Wiehe SE, Zapolski TCB. Alliances to disseminate addiction prevention and treatment (ADAPT): A statewide learning health system to reduce substance use among justice-involved youth in rural communities. J Subst Abuse Treat. 2021 Sep;128:108368. doi: 10.1016/j.jsat.2021.108368. Epub 2021 Mar 16. — View Citation

Aalsma MC, Dir AL, Zapolski TCB, Hulvershorn LA, Monahan PO, Saldana L, Adams ZW. Implementing risk stratification to the treatment of adolescent substance use among youth involved in the juvenile justice system: protocol of a hybrid type I trial. Addict Sci Clin Pract. 2019 Sep 6;14(1):36. doi: 10.1186/s13722-019-0161-5. — View Citation

Atwoli L, Mungla PA, Ndung'u MN, Kinoti KC, Ogot EM. Prevalence of substance use among college students in Eldoret, western Kenya. BMC Psychiatry. 2011 Feb 28;11:34. doi: 10.1186/1471-244X-11-34. — View Citation

Carney T, Johnson K, Carrico A, Myers B. Acceptability and feasibility of a brief substance use intervention for adolescents in Cape Town, South Africa: A pilot study. Int J Psychol. 2020 Dec;55(6):1016-1025. doi: 10.1002/ijop.12668. Epub 2020 Apr 13. — View Citation

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. Review. — View Citation

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. eCollection 2016. — View Citation

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. — View Citation

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. — View Citation

Gamarel KE, Brown L, Kahler CW, Fernandez MI, Bruce D, Nichols S; Adolescent Medicine Trials Network for HIV/AIDS Intervention. Prevalence and correlates of substance use among youth living with HIV in clinical settings. Drug Alcohol Depend. 2016 Dec 1;169:11-18. doi: 10.1016/j.drugalcdep.2016.10.002. Epub 2016 Oct 11. — View Citation

Harris SK, Csémy 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. — View Citation

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. — View Citation

Hoeft TJ, Fortney JC, Patel V, Unützer 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. — View Citation

Hogue A, Henderson CE, Becker SJ, Knight DK. Evidence Base on Outpatient Behavioral Treatments for Adolescent Substance Use, 2014-2017: Outcomes, Treatment Delivery, and Promising Horizons. J Clin Child Adolesc Psychol. 2018 Jul-Aug;47(4):499-526. doi: 10.1080/15374416.2018.1466307. Epub 2018 Jun 12. — View Citation

Hogue A, Henderson CE, Ozechowski TJ, Robbins MS. Evidence base on outpatient behavioral treatments for adolescent substance use: updates and recommendations 2007-2013. J Clin Child Adolesc Psychol. 2014;43(5):695-720. doi: 10.1080/15374416.2014.915550. Epub 2014 Jun 13. Review. — View Citation

Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, de Lacerda RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S. Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction. 2008 Jun;103(6):1039-47. doi: 10.1111/j.1360-0443.2007.02114.x. Epub 2008 Mar 28. — View Citation

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. Review. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

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. — View Citation

Musyoka CM, Mbwayo A, Donovan D, Mathai M. Alcohol and substance use among first-year students at the University of Nairobi, Kenya: Prevalence and patterns. PLoS One. 2020 Aug 28;15(8):e0238170. doi: 10.1371/journal.pone.0238170. eCollection 2020. — View Citation

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

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

Peltzer K, Matseke G, Azwihangwisi M. Evaluation of alcohol screening and brief intervention in routine practice of primary care nurses in Vhembe district, South Africa. Croat Med J. 2008 Jun;49(3):392-401. — View Citation

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. — View Citation

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. — View Citation

Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8. — View Citation

Skevington SM, Dehner S, Gillison FB, McGrath EJ, Lovell CR. How appropriate is the WHOQOL-BREF for assessing the quality of life of adolescents? Psychol Health. 2014;29(3):297-317. doi: 10.1080/08870446.2013.845668. Epub 2013 Nov 6. — View Citation

Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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

Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. — View Citation

Winn LAP, Paquette KL, Donegan LRW, Wilkey CM, Ferreira KN. Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study. J Subst Abuse Treat. 2019 Aug;103:14-22. doi: 10.1016/j.jsat.2019.05.009. Epub 2019 May 14. — View Citation

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. — View Citation

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.

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

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. — View Citation

* 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