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.: PACTR201804003332337 Date of Approval: 17/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adolescent Executive Functioning and Drumming Study
Official scientific title Adolescent (HIV) Executive Function and Drumming (AHEAD) Study: a randomised controlled pilot trial of a group drumming programme aiming to improve executive functioning in adolescents with HIV
Brief summary describing the background and objectives of the trial HIV-associated neurocognitive disorder (HAND) in the highly active antiretroviral therapy (HAART) era is dominated by the mild forms of cognitive impairment and is often associated with executive function impairments. There are few studies specifically focused on adolescent HAND, particularly in rural sub-Saharan Africa and in behaviourally acquired HIV. It is important to look at adolescent executive functioning specifically because their executive control and self-regulation is still maturing. Executive functioning predicts important outcomes and behaviour, including adherence, academic outcomes and potentially sexual risk-taking. Impaired executive function could therefore contribute to worse outcomes. There are very few intervention studies in this age group aiming to improve executive functioning. Some research has been done on using computerised cognitive rehabilitation therapy (CCRT) in slightly younger age groups with limited success in terms of improving executive function. Mindfulness-based stress reduction (MBSR) also had limited success on improving EF in adolescents with HIV. Many other interventions have been tried in other populations. Short-term music-based interventions have started to show potential in younger age groups (Moreno et al 2011). Long-term musical training is associated with superior performance on executive function tasks (Zuk et al 2014). A group-based intervention would be developmentally appropriate in adolescence. Group drumming has been shown to improve attention on behavioural report measures in at-risk youth. We hypothesise that a group drumming intervention would be a feasible and acceptable intervention to improve executive function in adolescents with HIV. The primary objective of this study is to assess the feasibility and acceptability of a group drumming programme for adolescents in rural South Africa, with the secondary objectives being to assess the effects on executive function, behaviour and mental health.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AHEAD
Disease(s) or condition(s) being studied HIV-associated neurocognitive disorder,Infections and Infestations,Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 09/07/2018
Actual trial start date 14/07/2018
Anticipated date of last follow up 16/11/2018
Actual Last follow-up date 25/11/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Wits HREC protocol number M180291; OxTREC reference 23-17.
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 randomisation using a randomisation table generated by GraphPad QuickCalcs online random number generator Allocation not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Djembe drumming group 1 hour per week 8 weeks A hand drumming circle led by a trained facilitator with everyone sitting with his/her own drum in a circle. Progressively increasing rhythmic complexity with combination of core taught rhythms and improvised rhythms. 30
Control Group Passive control group N/A N/A The control group will not receive any intervention. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 12-19-year-old male and female adolescents with chronic diseases (both HIV-positive and HIV-negative participants will be included to protect the HIV status) attending the clinic. - Participant is willing and able to give informed consent (for those aged 18 or 19 years old) or assent (for those aged 12 to 17 years old). - The primary caregiver is willing to give informed consent for participation in the study on behalf of participants aged 12 to 17 years old. - Participant¿s HIV status is known. - Participant is willing to share his/her HIV status with the study team. - Participant knows his/her own HIV status. - The participant must currently live in the MRC/Wits Agincourt Research Site villages and plan to remain in the study area for the next 6 months. - profound hearing loss or deafness - current severe infective illness - another uncontrolled medical condition - cerebral palsy - known intellectual disability due to another cause - epilepsy - recent central nervous system infections - current or previous brain malignancies - a previous stroke - history of a significant head injury - current participation in a band or music group that involves the playing of musical instruments by the participant. 12 Year(s) 19 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 05/04/2018 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nuffield Department of Medicine Research Building University of Oxford Old Road Campus Roosevelt Drive, Oxford 00000 United Kingdom
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 06/04/2018 University of Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Research Office Faculty of Health Sciences, Offices 301/302/304 Phillip Tobias Building, third floor 29 Princess of Wales Terrance Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The attendance rates, attrition rates and number of logistical problems encountered during implementation will be used to assess the feasibility of the programme. Weekly during intervention phase
Primary Outcome The acceptability ratings from the early drop-out and endline acceptability questionnaires will be used as the outcome measure for acceptability of the intervention. Once at study exit (whether early or at endline)
Secondary Outcome OCS-Exec executive function test scores Baseline Endline
Secondary Outcome OCS-Exec Iowa Gambling Task Baseline Endline
Secondary Outcome Strengths and Difficulties Questionnaire emotional symptoms score Baseline Endline
Secondary Outcome Strengths and Difficulties Questionnaire hyperactivity/inattention score Baseline Endline
Secondary Outcome Strengths and Difficulties Questionnaire total difficulties score Baseline Endline
Secondary Outcome Strengths and Difficulties Questionnaire prosocial behaviour score Baseline Endline
Secondary Outcome Self-reporting questionnaire-20 (SRQ-20) score Baseline Endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kildare Clinic Kildare Village South Africa
Agincourt Community Health Centre Agincourt Village 1368 South Africa
Xanthia Clinic Xanthia Village South Africa
Cunningmoore Clinic Cunningmoore Village 1255 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Society for Education, Music and Psychology Research (SEMPRE) Gerry Farrell Travelling Scholarship Room 855 Institute of Education 20 Bedford Way London WC1H 0AL United Kingdom
Murray Speight Research Fund, Rhodes Trust South Parks Road Oxford OX1 3RG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Research Services, University Offices, Wellington Square Oxford OX1 2JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Andeline dos Santos University of Pretoria, Lynnwood Road, Elandspoort 357-Jr Pretoria 0132 South Africa
Dr Ryan Wagner Wits School of Public Health, 60 York Road, Parktown Johannesburg 2193 South Africa
Prof Alan Stein Department of Psychiatry, University of Oxford, Warneford Hospital, Warneford Lane Oxford OX3 7JX United Kingdom
Prof Gaia Scerif Department of Experimental Psychology, University of Oxford, Anna Watts Building, Walton Street Oxford OX3 6HG United Kingdom
Dr Sonkanise Nkosi University of Johannesburg Soweto Campus Soweto 1809 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kirsten Rowe kirsten.rowe@psych.ox.ac.uk +447743515289 / +27764821605 Linacre College, St Cross Road
City Postal code Country Position/Affiliation
Oxford OX1 3JA United Kingdom DPhil Student, Department of Psychiatry, University of Oxford
Role Name Email Phone Street address
Principal Investigator Ryan Wagner ryan.wagner@wits.ac.za +27 71 586 0906 Wits School of Public Health, 60 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Research Fellow, MRC/Wits Rural Public Health and Health Transitions Research Unit
Role Name Email Phone Street address
Public Enquiries Kirsten Rowe kirsten.rowe@psych.ox.ac.uk +447743515289 / +27764821605 Linacre College, St Cross Road
City Postal code Country Position/Affiliation
Oxford OX1 3JA United Kingdom DPhil Student, Department of Psychiatry, University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Kirsten Rowe kirsten.rowe@psych.ox.ac.uk +447743515289 / +27764821605 Linacre College, St Cross Road
City Postal code Country Position/Affiliation
Oxford OX1 3JA United Kingdom DPhil Student, Department of Psychiatry, University of Oxford
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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