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.: PACTR201511001345372 Date of Approval: 11/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of PTSD
Official scientific title Effectiveness of Prolonged Exposure for adolescents with PTSD, as administered by counsellors: Comparative trial of supportive counselling
Brief summary describing the background and objectives of the trial The proposed research aims to examine the effectiveness of a psychotherapeutic intervention administered by counsellors to treat the symptoms of PTSD in adolescents exposed to trauma. We aim to conduct a randomized controlled trial (RCT) to compare Prolonged Exposure for Adolescents (PE-A) to Supportive Counselling (SC) to determine the comparative effectiveness in reducing PTSD and associated symptoms in adolescents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Posttraumatic Stress Disorder
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 08/11/2012
Actual trial start date 08/02/2013
Anticipated date of last follow up 25/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
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 Computer generated permuted block, block size 6 Individuals assigned one at a time after assessment completed by primary investigator Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Prolonged Exposure Treatment 10 - 14 sessions 60 - 90 min Cognitive behavioural psychological treatment 33
Experimental Group Supportive Counselling 10 - 14 sessions 60 - 90 minutes Supportive counselling psychological treatment 33 Active-Treatment of Control Group
Experimental Group Supportive Counselling 10 - 14 sessions 60 - 90 minutes Supportive counselling psychological treatment 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents with chronic (at least 3-months) full PTSD and sub-threshold PTSD will be included. Sub-threshold PTSD is defined as having at least 1 re-experiencing symptom, at least 2 avoidance symptoms, 2 arousal symptoms and a score of 11 on the CPSS. Adolescents aged 13 to 17 years, who have experienced a single-incident interpersonal trauma (index-trauma), will be included. The experience of a previous trauma will not lead to exclusion from the study. Adolescents with conduct disorder will be excluded. Participants seeking or requiring alternative treatments (medication) will also be excluded. All other adolescents will be eligible for participation. This includes adolescents with, for example, comorbid mood disorders, anxiety disorders, substance use disorders and ADHD provided that PTSD is deemed to be the principal disorder requiring treatment. 13 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 08/08/2012 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
SU Medical Faculty, Parow Parow 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PTSD symptoms pre-, mid-, post-, 3 month-, 6-month, 12 month and yearly thereafter up to 5 years after treatment
Secondary Outcome Presence of PTSD diagnosis same as above
Secondary Outcome Presence of depression symptoms same as above
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cape Town high schools interested to participate in study To protect the child participants the individual schools may not be identified by name Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SURMEPI SU Medical school Parow 7500 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University SU Medical school Parow 7500 South Africa University
COLLABORATORS
Name Street address City Postal code Country
D Alexander SU Medical school Parow 7500 South Africa
I Mbanga SU Medical school Parow 7550 South Africa
T Jacobs SU Medical school Cape Town 7500 South Africa
S Seedat SU Medical school Cape Town 7500 South Africa
W Rossouw 67 Visagie Street Cape Town 7460 South Africa
E Yadin UPEN Philadelphia 19104 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jaco Rossouw jacorossouw@telkomsa.net +27215587198 67 Visagie Street
City Postal code Country Position/Affiliation
Cape Town 7460 South Africa Clinical Psychologist
Role Name Email Phone Street address
Public Enquiries Jaco Rossouw jacorossouw@telkomsa.net +27215587198 67 Visagie Street
City Postal code Country Position/Affiliation
Cape Town 7460 South Africa Clinical Psychologist
Role Name Email Phone Street address
Scientific Enquiries Jaco Rossouw jacorossouw@telkomsa.net +27215587198 67 Visagie Street
City Postal code Country Position/Affiliation
Cape Town 7460 South Africa Clinical Psychologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Trial Information Trial phase 09/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 18/11/2015 Did not understand the description, 2 treatment groups, one group a comparative treatment group Single group: all participants receive same intervention throughout study Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Ethics IsApprovedByEC 23/11/2015 Ethics letter received true true
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 09/07/2018 pactr update Other Paediatrics, Other
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 18/11/2015 Missed this item when filling in form the first time Outcome Assessors ,