Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203698019870 Date of Approval: 24/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ziyembekezo Za Umoyo--Promoting Hope, Forgiveness, Spirituality, Prudence and Self-control to Address Unhealthy Alcohol Use in Zambia: Evaluating and Scaling a Character Strengths Intervention
Official scientific title Ziyembekezo Za Umoyo--Promoting Hope, Forgiveness, Spirituality, Prudence and Self-control to Address Unhealthy Alcohol Use in Zambia: Evaluating and Scaling a Character Strengths Intervention
Brief summary describing the background and objectives of the trial Background: Unhealthy alcohol use (UAU) is a critical worldwide health concern, having been the leading global risk factor for premature death and disease among young people ages 15-49 for the past 30 years. In Zambia, alcohol contributes to the burden of HIV/AIDS, and high underage drinking rates increase the risk of school failure and alcohol use disorder. Character strengths such as spirituality, hope, prudence, forgiveness and self-control have been shown to correlate with decreased alcohol use. Two promising interventions which have been pilot tested in Zambia—Global Resilience Oral Workshops (GROW), a resilience training program, and Celebration of Liberation (CL), a faith-based substance use recovery program—show promise for enhancing these five character strengths and reducing UAU in adolescents and young adults. Objective: The Ziyembekezo Za Umoyo (Hopes for Life) Project will create two combined GROW/CL interventions, one focused on alcohol prevention for use in schools (GROW-CL), and the other (CL-GROW) focused on recovery from unhealthy alcohol use (UAU) for use in community-based settings, and test their ability to enhance five key character strengths (spirituality, hope, prudence, forgiveness and self-control) and decrease UAU in 800 urban and rural youths ages 13-24.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/03/2022
Actual trial start date
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ziyembekezo Schools Prevention Resilience Curriculum Ziyembekezo community intervention curriculum 90-minute behavioral intervention weekly 36 weeks school groups 48 weeks community groups Ziyembekezo Schools Prevention and Resilience Curriculum: The school-based prevention curriculum will build on lessons learned in the Global Resilience Oral Workshops (GROW) Zambia clinical trial (2017-2019), which led to decreased alcohol use in 643 Zambian youth ages 11-14. Weekly 90 minute GROW after-school sessions combine a variety of spiritual practices such as Bible storytelling, drama, music, dance, positive affirmations, prayer, meditation, gratitude and forgiveness exercises, along with resilience exercises from positive psychology such as problem solving, brainstorming, goal setting, role modelling, and active constructive response. Each session focuses on teaching and practicing one of the 24 Values in Action (VIA) character strengths. GROW’s 24 week curriculum will be followed by 12 weeks of Celebration of Liberation (CL) sessions which teach participants how to apply lessons learned in GROW to avoid Unhealthy Alcohol Use (UAU). Ziyembekezo Community Recovery and Character Growth Curriculum: This community-based intervention curriculum will build on lessons learned in two years of CL implementation that have spawned more than 400 CL recovery groups across Zambia and four neighbouring countries. Weekly 90 minute CL sessions use spiritual practices similar to those used in GROW to teach 10 practices for overcoming UAU. Each weekly session focuses on one of the 10 practices, a spiritual affirmation, or a health teaching lesson regarding medical problems caused by UAU, while also integrating teaching on one of the VIA character strengths. Two cycles of CL instruction will be followed by one cycle of GROW, to assist participants in focusing on character growth and resilience building that will help them move beyond a focus on abstinence from substances into a thriving and flourishing life. 400
Control Group Schools Prevention Curriculum community intervention curriculum Written education materials 36 weeks for schools 48 weeks for community Ziyembekezo Schools Prevention and Resilience Curriculum: The school-based prevention curriculum will build on lessons learned in the Global Resilience Oral Workshop GROW Zambia clinical trial (2017-2019), which led to decreased alcohol use in 643 Zambian youth ages 11-14. Weekly 90 minute GROW after-school sessions combine a variety of spiritual practices such as Bible storytelling, drama, music, dance, positive affirmations, prayer, meditation, gratitude and forgiveness exercises, along with resilience exercises from positive psychology such as problem solving, brainstorming, goal setting, role modelling, and active constructive response. Each session focuses on teaching and practicing one of the 24 Values in Action (VIA) character strengths. GROW’s 24 week curriculum will be followed by 12 weeks of Celebration of Liberation (CL) sessions which teach participants how to apply lessons learned in GROW to avoid UAU. Ziyembekezo Community Recovery and Character Growth Curriculum: This community-based intervention curriculum will build on lessons learned in two years of CL implementation that have spawned more than 400 CL recovery groups across Zambia and four neighbouring countries. Weekly 90 minute CL sessions use spiritual practices similar to those used in GROW to teach 10 practices for overcoming UAU. Each weekly session focuses on one of the 10 practices, a spiritual affirmation, or a health teaching lesson regarding medical problems caused by UAU, while also integrating teaching on one of the VIA character strengths. Two cycles of CL instruction will be followed by one cycle of GROW, to assist participants in focusing on character growth and resilience building that will help them move beyond a focus on abstinence from substances into a thriving and flourishing life. 400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School Inclusion Criteria: All students ages 13-18 who are enrolled in grade 8 classes and are in classes selected by their school administrator using the above criteria will be eligible to participate in the Ziyembekezo after school program. Wherever possible, entire classes will be recruited together to decrease selection bias. Students who attend recruitment sessions and sign assent forms will be included in the study, provided that their parents also attend recruitment sessions and sign consent forms. Community Inclusion Criteria: Youth ages 18-24 with known or suspected Unhealthy Alcohol Use (UAU) who attend an information session, agree to health habits screening, have an ASSIST alcohol score of 2 or more upon screening, and provide informed consent will be eligible for inclusion in the study. For the school intervention component, we will exclude youths who are not enrolled in a school that has agreed to participate in the research project. We will also exclude people not likely to remain in the area where the school is located to the completion of the study follow-up. For the community intervention component, we will exclude youths who have no documented evidence of UAU. We will also exclude people not likely to remain at the site to the completion of the study follow-up. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 24 Year(s) Both
Student Inclusion Criteria: All students ages 13-18 who are enrolled in grade 8 classes and are in classes selected by their school administrator using the above criteria will be eligible to participate in the Ziyembekezo after school program. Wherever possible, entire classes will be recruited together to decrease selection bias. Students who attend recruitment sessions and sign assent forms will be included in the study, provided that their parents also attend recruitment sessions and sign consent forms. Youth ages 18-24 with known or suspected UAU who attend an information session, agree to health habits screening, have an ASSIST alcohol score of 2 or more upon screening, and provide informed consent will be eligible for inclusion in the study. For the school intervention component, we will exclude youths who are not enrolled in a school that has agreed to participate in the research project. We will also exclude people not likely to remain in the area where the school is located to the completion of the study follow-up. For the community intervention component, we will exclude youths who have no documented evidence of UAU. We will also exclude people not likely to remain at the site to the completion of the study follow-up. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 24 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/02/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Zambia, Biomedical Research Ethics Committee, Ridgeway Campus, P.O. Box 50110, Lusaka, Zambia. Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/02/2022 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Chalala Office Lot No. 18961/M, Off Kasama Road Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes are reduced alcohol use and increases in prudence, forgiveness, hope, self-control, and spirituality. Alcohol use will be measured using WHO’s Global School Health Survey quantity-frequency measures and the Zambian ASSIST alcohol score and for community participants, additional measures include AUDIT-C and daily drinking questionnaire. Measures for prudence, hope, self-control, forgiveness, and spirituality will be developed in the study. Four different time points every 6 months
Secondary Outcome (1) reduction in HIV risk behaviors; (2) increase in quality of life scores; and (3) increases in the five key character strengths targeted by the interventions (measured using character strength measures developed and validated as part of this study). Every 6 months after start of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Serenity Harm Reduction Programme of Zambia Roma Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Templeton World Charity Foundation Bayside Executive Park Building 2, 2nd Floor West Bay street Nassau Bahamas
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Templeton World Charity Foundation Bayside Executive Park, Building 2, 2nd Floor, West Bay street Nassau 242 Bahamas Charities/Societies/Foundation
Secondary Sponsor AIRO Healthcare Inc. 153 Saddle run court Macon Georgia 31210 USA United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wilbroad Mutale wmutale@yahoo.com +260967780284 2882/3 Ibex Hill
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Paul Seale jseale@augusta.edu +14789720972 1120 15th Street, CJ2300
City Postal code Country Position/Affiliation
Augusta GA 30912 United States of America Proffesor
Role Name Email Phone Street address
Public Enquiries Mataanana Mulavu mataananamulavu@gmail.com +260976068927 Plot 11323 off leopards hill road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Project Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After de-identification, all individual participant data collected during this trial as part of the project’s quantitative evaluation component, including data dictionaries, will be made available on or before September 30, 2024, the final date of the project’s grant funding. We will also provide a copy of the study protocol. Statistical Analysis Plan,Study Protocol Data will be made available on 30th September 2024. Data will be shared with researchers who provide a methodologically sound proposal, such as a meta-analysis or a proposal that would advance scientific inquiry related to issues addressed by this study (e.g. reduction of unhealthy alcohol use, interventions to enhance character strengths, studies of the impact of spiritual interventions, etc.). The study data will be posted online with Open Science Framework. Proposals should be directed to Dr. Wilbroad Mutale at wmutale@yahoo.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information