The Computer-based Drug and Alcohol Training Assessment in Kenya

NCT02388243 | Completed

• 2 other identifiers: GMH 0092-04RCT protocol
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of the two RCT registered here is to determine whether clinicians trained on the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)-linked brief intervention (BI) through the NextGenU.org model of training are able to deliver effective brief intervention for risky level of alcohol use. It is one study part of a larger program of research. The investigators hypothesize that the NextGenU.org model of online training with mentor and peer activities is an effective way to train clinicians to deliver the ASSIST-linked brief intervention. The investigators hypothesize that eligible participants receiving the brief intervention will decrease their alcohol consumption and experienced improved health and social outcomes more than those receiving only screening results and written information (p\<0.05). The investigators hypothesize the level of decrease in alcohol consumption will be similar to that of trials conducted in high-income countries (HIC).

Conditions

Alcohol-Related Disorders; Social Stigma; Substance-Related Disorders

Keywords

Brief intervention; Low and middle income countries (LMIC); eLearning; Screening; Capacity Building; Primary Health Care; Education, Medical; Education, Nursing; Education, Professional; Community Health Workers

Outcome Measures

Primary Outcomes (1)

• Mean Difference in alcohol consumption

  Difference in alcohol consumption between intervention and control (average grams/week in previous 7 and 14 day use collected through a timeline follow-back assessment.)

  one, three and six month post BI

Secondary Outcomes (8)

• Change from baseline in frequency of drinking

  baseline, one, three, and six months

• Change from baseline in alcohol consumption

  baseline, one, three, and six months

• Change from baseline in frequency of binge drinking

  baseline, and at one, three, and six months

• Change from baseline in stigma related to alcohol use

  baseline, and at one, three, and six months

• difference between group in stigma related to alcohol use,

  baseline, and at one, three, and six months

Other Outcomes (1)

• treatment outcomes

  baseline, one, three, and six months

Study Arms (4)

Brief Intervention in Public Clinic

EXPERIMENTAL

Written information after screening; 15 minutes or so brief intervention at recruitment with follow-up visit of about the same length after one month; in public clinic.

Behavioral: Brief Intervention in Public Clinic

Screening results in Public Clinic

ACTIVE COMPARATOR

Written information after screening; No brief intervention; in public clinic.

Behavioral: Screening Results in Public Clinic

Brief Intervention in Private Clinic

EXPERIMENTAL

Written information after screening; 15 minutes or so brief intervention at recruitment with follow-up visit of about the same length after one month; in private clinic.

Behavioral: Brief Intervention in Private Clinic

Screening results in Private Clinic

ACTIVE COMPARATOR

Written information after screening; No brief intervention; in private clinic.

Behavioral: Screening Results in Private Clinic

Interventions

Brief Intervention in Public Clinic BEHAVIORAL

The ASSIST-linked brief intervention includes a discussion, between the clinician and patient, of problem drinking and its associated adverse effects and how to address risky level of alcohol use, using motivational interviewing techniques, assess and manage any complication or co-morbidity uncovered, and request to the patient to follow-up in one month. Clinicians will also be asked to record their baseline and follow-up clinical assessment and management through clinical follow-up forms. The total brief intervention should be around 15 minutes, with a follow-up visit of about the same length a month later. This intervention in happening in a public clinic.

Also known as: ASSIST-linked brief intervention in public clinic

Brief Intervention in Public Clinic

Screening Results in Public Clinic BEHAVIORAL

At each public clinic, a community health worker will ask patients presenting for consultation who are aged 18 years or older to be screened for healthy lifestyle and to receive feedback on their results. The screening will include self-reported weight and height, (for BMI calculation), level of physical activity, and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The inclusion of the BMI and level of physical activity is to mask the purpose of the intervention, by decreasing the focus on substance use. The community health worker will provide the results of the BMI, physical activity and the ASSIST and will offer a leaflet with further explanation about how to address problems with those lifestyles

Also known as: Screening Results and Written Information in Public Clinic

Screening results in Public Clinic

Brief Intervention in Private Clinic BEHAVIORAL

The ASSIST-linked brief intervention includes a discussion, between the clinician and patient, of problem drinking and its associated adverse effects and how to address risky level of alcohol use, using motivational interviewing technics, assess and manage any complication or co-morbidity uncovered, and request to the patient to follow-up in one month. Clinicians will also be asked to record their baseline and follow-up clinical assessment and management through clinical follow-up forms. The total brief intervention should be around 15 minutes, with a follow-up visit of about the same length a month later. This intervention in happening in a private clinic.

Also known as: ASSIST-linked brief intervention in Private Clinic

Brief Intervention in Private Clinic

Screening Results in Private Clinic BEHAVIORAL

At each private clinic, a support staff will ask patients presenting for consultation who are aged 18 years or older to be screened for healthy lifestyle and to receive feedback on their results. The screening will include self-reported weight and height, (for BMI calculation), level of physical activity, and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The inclusion of the BMI and level of physical activity is to mask the purpose of the intervention, by decreasing the focus on substance use. The support staff will provide the results of the BMI, physical activity and the ASSIST, and will offer a leaflet with further explanation about how to address problems with those lifestyles.

Also known as: Screening Results and Written Information in Private Clinic

Screening results in Private Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Have an Assist alcohol score of 11 to 26

You may not qualify if:

• Being pregnant
• Reaching a score of 27 or higher in one or more substances (other than tobacco or cannabis)
• Having attended an alcohol treatment program in the last year
• Reporting symptoms of suicide
• Having severe neurological or psychiatric impairment (such as overt psychosis)

Sponsors & Collaborators

• Africa Institute of Mental and Brain Health (AFRIMEB): lead
• Grand Challenges Canada: collaborator
• University of British Columbia: collaborator
• Nextgenu.org: collaborator
• CliniX Healthcare Limited: collaborator
• Presbyterian University of Eastern Africa: collaborator
• Kenya Medical Training College: collaborator

Study Sites (10)

Kibwezi subCounty Hospital

Kibwezi, Makueni County, Kenya

Location

Kalii Dispensary

Makindu, Makueni County, Kenya

Location

Kaunguni Dispensary

Makindu, Makueni County, Kenya

Location

Kiboko Health Centre

Makindu, Makueni County, Kenya

Location

Makindu subCounty Hospital

Makindu, Makueni County, Kenya

Location

Kola Health Centre

Machakos, Kenya

Location

Machakos Level 5 Hospital

Machakos, Kenya

Location

Mutituni Health Centre

Machakos, Kenya

Location

Shalom Hospital Athi River

Machakos, Kenya

Location

CliniX Buruburu

Nairobi, Kenya

Location

Related Publications (27)

• World Health Organization The global burden of disease: 2004 update. Geneva: WHO; 2008

  BACKGROUND

• World Health Organization. Global health risks: mortality and burden of disease attributable to selected major risks. ISBN 978 92 4 156387 1. WHO. 2009.

  BACKGROUND

• World Health Organization/Wonca Integrating Mental Health into Primary Care: a global perspective Geneva: World Health Organization, 2008

  BACKGROUND

• Humeniuk RE H-ES, Ali RL, Poznyak V, Monteiro MG. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): Manual for Use in Primary Care. Geneva, Switzerland: World Health Organization; 2010.

  BACKGROUND

• mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP). Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138690/

  PMID: 23741783 BACKGROUND

• Kaner EF, Beyer F, Dickinson HO, Pienaar E, Campbell F, Schlesinger C, Heather N, Saunders J, Burnand B. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004148. doi: 10.1002/14651858.CD004148.pub3.

  PMID: 17443541 BACKGROUND

• Ndetei DM, Khasakhala LI, Ongecha-Owuor FA, Kuria MW, Mutiso V, Kokonya DA. Prevalence of substance abuse among patients in general medical facilities in Kenya. Subst Abus. 2009 Apr-Jun;30(2):182-90. doi: 10.1080/08897070902802125.

  PMID: 19347756 BACKGROUND

• Ndetei DM KL, Odinga A. Baseline Study: The Mental Health Situation in Kangemi informal settlement Nairobi-Kenya: BasicNeeds Kenya; 2007

  BACKGROUND

• Ndetei DM KL, Omolo JO. Incentives for health worker retention in Kenya: An assessment of current practice Kenya: Africa Mental Health Foundation (AMHF), Institute of Policy Analysis and Research (IPAR), Kenya; 2008 May 2008.

  BACKGROUND

• Ndetei DM KL, Ongecha FA, Kokonya D, Mutiso V, Kuria M, Odhiambo G, Akanga S. A Study of Drug Use in Five Urban Centres in Kenya. African Journal of Drug and Alcohol Studies 2008;7:10.

  BACKGROUND

• Ndetei DM KL, Omolo JO. Incentives for health worker retention in Kenya. Health Systems Reporter 2009

  BACKGROUND

• Ndetei DM KM, Khasakhala L, Maru HM, Mutiso V, Mwangi J. Substance Abuse and Psychiatric Co-morbidities: A Case Study of Patients at Mathari Psychiatric Hospital, Nairobi, Kenya. African Journal of Drug and Alcohol Studies 2008;7:6

  BACKGROUND

• Ndetei DM, Mathai M, Khasakhala LI, Mutiso V, Mbwayo AW. University medical education in Kenya: The challenges. Med Teach. 2010;32(10):812-5. doi: 10.3109/0142159X.2010.496011.

  PMID: 20854156 BACKGROUND

• Ndetei DM OF, Malow RM, Onyancha J, Mutiso V, Kokonya D, Khasakhala L, Odhiambo G, Rosenberg R. Next Priorities for International in Kenya: Results from Cohort study of Drug Use, HIV and HCV Patterns in Five Urban Areas. International Psychology Reporter 2006;10:3

  BACKGROUND

• Ndetei DM OF, Mutiso V, Kuria M, Khasakhala LI, Kokonya DA. The challenges of human resources in mental health in Kenya. South African Psychiatry Review 2007;10:4

  BACKGROUND

• Ndetei DM, Pizzo M, Khasakhala LI, Maru HM, Mutiso VN, Ongecha-Owuor FA, Kokonya DA. Perceived economic and behavioural effects of the mentally ill on their relatives in Kenya: a case study of the Mathari Hospital. Afr J Psychiatry (Johannesbg). 2009 Nov;12(4):293-9. doi: 10.4314/ajpsy.v12i4.49050.

  PMID: 20033112 BACKGROUND

• Kuria, M. Factors associated with relapse and remission of alcohol dependent persons after community based treatment. Open Journal of Psychiatry, 3, 264-272. doi: 10.4236/ojpsych.2013.32025, 2013

  BACKGROUND

• McKimm J, Jollie C, Cantillon P. ABC of learning and teaching: Web based learning. BMJ. 2003 Apr 19;326(7394):870-3. doi: 10.1136/bmj.326.7394.870. No abstract available.

  PMID: 12702625 BACKGROUND

• Phipps R, Merisotis J. What's the Difference? A Review of Contemporary Research on the Effectiveness of Distance Learning in Higher Education Policy report: The Institute for Higher Education Policy; 1999.

  BACKGROUND

• Harden RM, Hart IR. An international virtual medical school (IVIMEDS): the future for medical education? Med Teach. 2002 May;24(3):261-7. doi: 10.1080/01421590220141008.

  PMID: 12098412 BACKGROUND

• 2005 Program Evaluation Findings Report: Massachusetts Institute of Technology, MIT OpenCourseWare; 2006 June 5, 2006.

  BACKGROUND

• Kahn JG YJ, Kahn JS.

  BACKGROUND

• Richwine MP, McGowan JJ. A rural virtual health sciences library project: research findings with implications for next generation library services. Bull Med Libr Assoc. 2001 Jan;89(1):37-44.

  PMID: 11209799 BACKGROUND

• Browling A, Ebrahim S. Handbook of Health Research Methods: McGraw-Hill International; 2005.

  BACKGROUND

• Fleming MF, Barry KL, Manwell LB, Johnson K, London R. Brief physician advice for problem alcohol drinkers. A randomized controlled trial in community-based primary care practices. JAMA. 1997 Apr 2;277(13):1039-45.

  PMID: 9091691 BACKGROUND

• Lillie E KM, and Stuart H. Opening Minds at University: Results of a Contact--Based Anti-Stigma Intervention Mental Health Commission of Canada.

  BACKGROUND

• Bokhar MU IA. Open Source Tools: Empowered the E-learning Pedagogy in Distance Education. International Journal of Computer Technology and Applications 2011;2:6.

  BACKGROUND

Related Links

• Africa Mental Health Foundation webpage about the Project
• NextGenU site which gives access to the online courses
• the funding organisation

MeSH Terms

Conditions

Alcohol-Related Disorders; Social Stigma; Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David M Ndetei, PhD

  Africa Institute of Mental and Brain Health (AFRIMEB)

  PRINCIPAL INVESTIGATOR

• Erica Frank, MD, MPH

  University of British Columbia, NextGenU.org

  PRINCIPAL INVESTIGATOR

• Victoria N Mutiso, PhD

  Africa Institute of Mental and Brain Health (AFRIMEB)

  PRINCIPAL INVESTIGATOR

• Veronic Clair, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (10)