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.: PACTR202011506380839 Date of Approval: 25/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomised controlled trial of TF-CBT in South African adolecents
Official scientific title A randomised controlled trial of TF-CBT in South African adolecents
Brief summary describing the background and objectives of the trial Although there is a high prevalence of trauma exposure and posttraumatic symptomatology in South African adolescents, few studies have evaluated interventions for these outcomes in this population. This study is a two-armed randomised controlled trial (RCT) comparing an abbreviated 8-sesssion version of trauma-focused cognitive behaviour therapy (TF-CBT) with enhanced treatment as usual (enhanced-TAU) for the treatment of posttraumatic stress disorder (PTSD) and depression amongst trauma-exposed adolescents in South Africa. Participants will be assessed at baseline, post-treatment and at 3-month, 1 year and 2 year follow ups.
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 Psychosocial
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 75
Recruitment status Closed to recruitment,follow-up continuing
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Traumafocused CBT or TFCBT 8 sessions, delivered weekly 8 weeks An abbreviated 8-session version of TF-CBT that includes the following components: relaxation training, affect modulation, cognitive coping, trauma narrative, cognitive reprocessing and safety planning. TF-CBT is a conjoint treatment that involves adolescent participants and a caregiver. In each session, the counsellor spends 45 minutes with the adolescent and 45 minutes with the caregiver. The treatment modules are supplemented with homework tasks. 37
Control Group Enhanced treatment as usual or enhanced TAU Control participants are referred to usual services in their residential area, including government mental health services and community-based NGOs. Treatment may vary in number and frequency of sessions, depending on what that service provider prescribes. 8 weeks Control participants are referred to usual services in their residential area, including government mental health services and community-based NGOs.Treatment decisions are then determined by the relevant person at the clinic or treatment agency. Psychotherapy services in the state health clinics are delivered by intern psychologists or registered counsellors working under weekly supervision by clinical psychologists, while psychiatric treatment is delivered by medical officers and psychiatric registrars. Community-based NGOs in most cases offer services by volunteer counsellors or social workers. Treatment as usual may vary in session number and content. The treatment as usual is enhanced because the research coordinator facilitates the referral for the participant to maximise the likelihood of the participant accessing the service and then follows up with the participant every two weeks to assess risk for suicidality, homicidality or abuse. 38 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must have been exposed to a traumatic event according to the DSM 5 PTSD Criterion A. Participants must meet criteria for a clinical or subclinical diagnosis of PTSD according to the DSM-5, as assessed using the KSADS-PL and the CPSS-5. Subclinical PTSD is defined as having at least 1 re-experiencing symptom, at least 2 avoidance symptoms, 2 arousal symptoms and/or a score of at least 21 on the CPSS-5. Adolescents with both acute (1-3 months post-trauma) and chronic (>3 months post-trauma) PTSD will be included into the study, given that the evidence for TF-CBT shows benefit for both acute and chronic groups. Provided that PTSD is the primary disorder requiring treatment, adolescents with comorbid mood disorders, anxiety disorders, substance use disorders and behavioural disorders (of oppositional defiant disorder, conduct disorder or and attention-deficit/hyperactivity disorder) and sub-clinical substance misuse will be included. At least six years of formal education. Proficiency in English or Afrikaans. Intellectual disability or autism spectrum disorder Psychotic disorder High suicide risk Clinically significant alcohol or substance abuse Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 11 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 07/03/2016 Stellenbosch University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University Faculty of Medicine and Health Sciences, Francie van Zyl Dr, Parow Cape Town 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 18/06/2014 University of Cape Town Faculty of Humanities Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Uuniversity of Cape Tow, Rondeboch, 7700 Cape Town 7700 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PTSD diagnosis as assessed on the K-SADS PL Baseline, post-treatment, 3-month follow up, 1 year follow up, 2 year follow up
Primary Outcome PTSD symptom severity as assessed by the CPSS 5 Baseline, post-treatment, 3-month follow up, 1 year follow up, 2 year follow up
Secondary Outcome Major depressive disorder assessed with the K-SADS PL Baseline, post-treatment, 3-month follow up, 1 year follow up, 2 year follow up
Secondary Outcome Severity of depression symptoms assessed with the Beck Depression Inventory II Baseline, post-treatment, 3-month follow up, 1 year follow up, 2 year follow up
Secondary Outcome Severity of aggression symptoms assessed with the Aggression Questionnaire Baseline, post-treatment, 3-month follow up, 1 year follow up, 2 year follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bathuthuzele Youth Stress Clinic Stellenbosch University Department of Psychiatry, Faculty of Medicine and Health Sciences, Francie van Zyl Dr, Parow Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Meiring Naude Rd, Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debra Kaminer Department of Psychology, University of Cape Town, Rondebosch, 7700 Cape Town 7700 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Soraya Seedat Stellenbosch University Department of Psychiatry, Faculty of Medicine and Health Sciences, Francie van Zyl Dr, Parow Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Debra Kaminer debbie.kaminer@uct.ac.za +27216503900 Department of Psychology, University of Cape Town, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Associate Professor University of Cape Town Psychology Department
Role Name Email Phone Street address
Public Enquiries Debra Kaminer debbie.kaminer@uct.ac.za +27216503900 Department of Psychology, University of Cape Town, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Associate Professor University of Cape Town Psychology Department
Role Name Email Phone Street address
Scientific Enquiries Debra Kaminer debbie.kaminer@uct.ac.za +27216503900 Department of Psychology, University of Cape Town, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Associate Professor University of Cape Town Psychology Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A results summary will be available on the University of Cape Town Open Data Repository (https://zivahub.uct.ac.za/) after publication. To access the data that underlie results published in any articles merging from the study, a proposal should be directed to Debbie.kaminer@uct.ac.za. To gain access, data requestors will need to sign a data access agreement. Data are from three months after publication for a period of fifteen years. Study Protocol From three months after publication for 15 years To access the data that underlie results published in any articles merging from the study, a proposal should be directed to Debbie.kaminer@uct.ac.za. To gain access, data requestors will need to sign a data access agreement.
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