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.: PACTR202003522145106 Date of Approval: 18/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Project Aspire: Expanding mental health counselling to reach at-risk adolescents.
Official scientific title Expanding mental health counselling from primary care to reach at-risk youth.: MIND-Y
Brief summary describing the background and objectives of the trial Like many low- and middle-income countries (LMICs), South Africa (SA) faces the challenge of how to reduce the high prevalence of common mental disorders within its under-resourced health care system. There have been several initiatives to increase access to mental health counselling in SA, primarily through the integration of counselling for common mental disorders into primary health care (PHC) services. While these efforts are starting to reduce the treatment gap for adults who access PHC services, at-risk adolescents (15-18) generally do not utilise these services. To address this gap, we propose a feasibility trial to explore how to expand mental health counselling from primary health care services to reach at risk youth in community settings. The main objectives are to (i) test the feasibility and acceptability of a youth-focused motivational interviewing and problem solving therapy intervention as well recruitment procedures and performance of outcome measures to inform a fully powered future trial. A second objective is to explore the initial effect of this intervention on volume of alcohol consumed and symptoms of depression. It is hoped that the findings from this feasibility test will lay a foundation for future studies that provide more robust evidence of the impact of mental health counselling for at-risk youth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ASPIRE
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/10/2019
Actual trial start date 18/11/2019
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Motivational interviewing and referral to care one session of counselling and referral to care 60 minutes Participants assigned to this arm will receive a single counselling session (~1 hour in duration). This is session 1 of the ASPIRE intervention, and the content and delivery of this session will be identical to that received by participants assigned to the intervention condition. The session includes screening for heavy alcohol use and depression, feedback about the screening results and levels of risk, psycho-education about how alcohol or feelings of depression can affect young people, and (depending on their primary condition), motivational interviewing to enhance motivation to reduce alcohol use or behavioural activation to address symptoms of depression. The session will conclude with setting personal goals and developing a plan for change. Participants will also be given referrals to usual care providers for further follow up. 1 Active-Treatment of Control Group
Experimental Group Motivational interviewing and problem solving therapy 4 counselling sessions, each spaced a week apart up to 4 hours of counselling Participants assigned to this condition will receive a four-session blended MI-PST intervention. The goals are to motivate participants to make changes to their risk behaviours and strengthen their problem-solving skills to help them cope better with stress and life problems that are risk factors for common mental disorders. The intervention, based on Lazarus and Folkman’s (1984) coping theory, teaches problem-focused coping skills for mutable problems and emotion-focused coping strategies (acceptance and seeking support) for immutable problems. Each session functions iteratively to build readiness to change and adaptive problem-solving and coping skills. All sessions have a motivational component, a psycho-education component (in which participants are taught problem-solving skills and how to apply them) and include an opportunity to apply newly learned skills through exercises and homework. More specifically, participants are taught steps for addressing problems that are important and can be solved; strategies for dealing with negative and intrusive worries that are unimportant; and steps for coping with problems that are important but cannot be solved. Participants are also taught emotional regulation techniques. A patient handbook, summarizing the content of the counselling sessions and containing worksheets that participants use to practice the problem-solving method, is used to guide counselling. 1
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Provide written informed assent/ consent to participate in the study • Have written informed parental consent to participate (if younger than 18 years of age). • Be between 15 and 18 years old • Screen at risk for depression, with a CES-D 10 score ≥10 and/or • Screen at moderate or severe risk for alcohol-related health problems, with an ASSIST-Y score ≥ 5) and report at least 2 episodes of heavy drinking (≥ 5 drinks) in the last month. • Currently receiving treatment (counselling or medication) for a mental or substance use disorder. • Participating in another intervention research study. Adolescent: 13 Year-18 Year 15 Year(s) 18 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 26/08/2019 South African Medical Research Councils Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Duiker Street, Francie Van Zyl Drive Parow 7505 South Africa
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 19/09/2019 University of Cape Towns Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Barnard Fuller Building, Anzio Road, Observatory Cape Town 7935 South Africa
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 31/10/2019 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London 1575 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants reporting heavy alcohol use at baseline who achieve significant reductions in the number of days of heavy drinking baseline, 6 weeks and 3 months post-enrollment
Primary Outcome Proportion of participants reporting risk of depression at baseline who report significant reductions in CES-D 10 scores at 6- week and 3- month end-points. baseline 6 weeks and 3 months post-enrolment
Secondary Outcome Generalised anxiety as measured by the GAD-7 scale baseline, 6 weeks and 3 months post-enrolment
Secondary Outcome Tobacco and other drug use Baseline, 6 weeks and 3 months post-enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Delft South African Medical Research Council Driftsands, Off Hindle Road, Brentwood Park Cape Town 7580 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Joint funding Global Health Trials United Kingdom Research Initiative UKRI Polaris House North Star Avenue Swindon Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council 1 Duiker Street Francie Van Zyl Drive Parow 7505 South Africa Research Institute
COLLABORATORS
Name Street address City Postal code Country
Prof Katherine Sorsdahl Centre for Public Mental Health, University of Cape Town, Sawkins Avenue Rondebosch 7505 South Africa
Dr Melissa Neuman London School of Hygiene and Tropical Medicine, Keppel Street, London London United Kingdom
Prof Helen Weiss London School of Hygiene and Tropical Medicine, Keppel Street, London London United Kingdom
Dr Claire van der Westhuizen Centre for Public Mental Health, University of Cape Town, Sawkins Avenue Rondebosch South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bronwyn Myers bmyers@mrc.ac.za 27219380993 Alcohol Tobacco and Other Drug Research Unit, South African Medical Research Council, Francie Van Zyl Drive
City Postal code Country Position/Affiliation
Parow 7505 South Africa Chief Specialist Scientist
Role Name Email Phone Street address
Scientific Enquiries Bronwyn Myers bmyers@mrc.ac.za 27219380993 South African Medical Research Council, Francie Van Zyl Drive,
City Postal code Country Position/Affiliation
Parow 7505 South Africa Chief Specialist Scientist
Role Name Email Phone Street address
Public Enquiries Nancy Hornsby nancy.hornsby@mrc.ac.za 27219380398 South African Medical Research Council Francie Van Zyl Drive
City Postal code Country Position/Affiliation
Parow 7505 South Africa Scientist
Role Name Email Phone Street address
Principal Investigator Katherine Sorsdahl katherine.sorsdahl@uct.ac.za 27216504798 Centre for Public Mental Health, University of Cape Town, Sawkins Road
City Postal code Country Position/Affiliation
Rondebosch South Africa Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data and the study codebook will be available on request from the principal investigator after publication of the main outcomes. Summary results will be available on the project's webpage within 12 months of the study completion date. Study Protocol Summary results will be available 12 months after study completion. De-identified data will be available to other researchers after publication of the main study outcomes. Requests for access to the data should be made using the data request form available on the project website. If a publication on the topic has been planned, but not published, or if the users plan to replicate an analysis already completed, the external users can submit an enquiry to the SAMRC principal investigator who will then contact the authors of the planned output. If the authors registered the planned output more than 6 months previously, and if significant progress has not been made, the topic may become available to the applicant. Should the elapsed time be less than 6 months or the authors are nearing completion, the external users will be informed that the topic is not available, but that they may check on the website again after a certain period of time, as communicated by the project team.
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
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 06/03/2020 Record was incomplete Prof Katherine Sorsdahl, Centre for Public Mental Health, University of Cape Town, Sawkins Avenue, Rondebosch, 7505, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 06/03/2020 Record was incomplete Dr Melissa Neuman, London School of Hygiene and Tropical Medicine, Keppel Street, London, London, , United Kingdom
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 06/03/2020 Record was incomplete Prof Helen Weiss, London School of Hygiene and Tropical Medicine, Keppel Street, London, London, , United Kingdom
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 06/03/2020 Incomplete record Dr Claire van der Westhuizen, Centre for Public Mental Health, University of Cape Town, Sawkins Avenue, Rondebosch, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 06/03/2020 We have updated this as per the feedback of the trial reviewer Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 06/03/2020 We have updated this as per the feedback of the trial reviewer De-identified individual participant data and the study codebook will be available on request from the principal investigator after publication of the main outcomes. Summary results will be available on the project's webpage within 12 months of the study completion date.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 06/03/2020 We have updated this as per the feedback of the trial reviewer Summary results will be available 12 months after study completion. De-identified data will be available to other researchers after publication of the main study outcomes.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 06/03/2020 We have updated this as per the feedback of the trial reviewer Requests for access to the data should be made using the data request form available on the project website. If a publication on the topic has been planned, but not published, or if the users plan to replicate an analysis already completed, the external users can submit an enquiry to the SAMRC principal investigator who will then contact the authors of the planned output. If the authors registered the planned output more than 6 months previously, and if significant progress has not been made, the topic may become available to the applicant. Should the elapsed time be less than 6 months or the authors are nearing completion, the external users will be informed that the topic is not available, but that they may check on the website again after a certain period of time, as communicated by the project team.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 06/03/2020 We have updated this as per the feedback of the trial reviewer Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 06/03/2020 This is an ongoing trial, no results are available No No