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.: PACTR201906746835089 Date of Approval: 03/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Development, implementation and evaluation of a CBT-based intervention for the management of anxiety symptoms in South African children with visual impairments
Official scientific title Research Protocol: Development, implementation and evaluation of a cognitive behavioural therapy -based intervention programme for the management of anxiety symptoms in South African children with visual impairments
Brief summary describing the background and objectives of the trial The study was motivated by the dearth of research on this topic and aimed to examine the effects of a specifically tailored, group-based, universally delivered, cognitive behavior therapy intervention for anxiety in children with visual impairments, and to examine the influence of three predictor variables (i.e., age, gender and level of visual impairment) on prevention effects. A randomized wait-list control group design with pre-, post- and follow-up intervention measures was employed. The final sample of 52 assenting children (aged 9–13) with varying degrees of visual impairment received the anxiety intervention. Participants were followed over a course of ten months during which their anxiety symptoms were assessed quantitatively at four time points (T1–T4).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PAM
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 13/02/2014
Actual trial start date 24/02/2014
Anticipated date of last follow up 19/08/2014
Actual Last follow-up date 03/11/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL http:/www.ajod.org/10.4102/ajod.v4i1.160
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PAM anxiety intervention programme 10 sessions of anxiety intervention programme Participants received the 10 PAM group sessions over the course of 5 weeks. It was delivered twice weekly and lasted approximately 45 minutes each. The study employed a randomised wait-list control group design with pre-, post- and follow-up intervention measures, with two groups (immediate intervention and delayed interventiongroup) each receiving a 10 session anxiety intervention programme. The main outcome measure relates to the participants' symptoms of anxiety as indicated on the Revised Child Anxiety and Depression Scale. 27
Control Group PAM anxiety intervention programme 10 sessions of 45 minutes each 5 weeks X two sessions per week A specifically tailored CBT-based anxiety intervention (PAM program) for South African children with visual impairments was evaluated in two special schools (school 1 and school 2). The study was set up as a randomized wait-list control group design with pre-, post- and follow-up intervention measures. Participants were randomly assigned to either an IIG (immediate intervention group or experimental group) or a DIG (delayed intervention group or the control in this case) at their school. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children with visual impairments attending two special schools in South Africa universal prevention where participants were included regardless of anxiety status participants age between 9 and 13 regardless of visual impairment, no other disability Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 13 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 31/01/2013 Research Ethics Committee Human Research Humaniora at Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Victoria Streets Stellenbosch 7600 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure relates to the participants symptoms of anxiety as indicated on the RCADS-30 and PSWQ-S. After assenting to participate, the 52 participants were randomly assigned to either an IIG or DIG at their respective school. During data analysis, the IIG’s from School 1 and School 2 were combined to form one IIG, and the DIG’s from School 1 and School 2 were combined to form one DIG. The combined IIG included 27 participants (15 boys, 12 girls) with a mean age of 11.44 (SD = 1.47); and the combined DIG included 25 participants (13 boys, 12 girls) with a mean age of 11.58 (SD = 1.35).Both of the programmes groups received the 10 session PAM anxiety intervention programme. They completed evaluations at 4 points. The PAM program did not lead to post intervention reductions in self-reported anxiety and worry scores on the RCADS-30 and PSWQ-C. These non-significant results may relate to the fact that base-line anxiety symptoms were unexpectedly low. The overall mean score within each group virtually remained unchanged from T1 to T4. 4 points
Secondary Outcome The secondary outcome A second aim of the present study was to examine the effects of the predictor variables of age, gender and level of visual impairment. Younger (9–11-year-olds) and legally blind participants reported significant reductions in anxiety scores on the RCADS-30 from pre- (T1) to post- (T3) test. Girls also reported a significant reduction in worry scores on the PSWQ-C. Thus, although there were no overall effects, it appears that the PAM program may be beneficial for girls, younger participants (aged 9–11) and legally blind children. Results relating to the legally blind group are particularly noteworthy, as children with severe visual impairments have been identified as a high-risk group. It is also encouraging to note the effects relating to a decrease in symptoms of major depression for younger (age 9–11-year-olds) and legally blind children. These results are important as it has been noted that some larger scale depression prevention studies have recently found non-significant universal effects. 4 points
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Stellenbosch University corner of Victoria and Ryneveld Streets Stellenbosch 7600 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Meiring Naude Road Pretoria 0001 South Africa
Fulbright Scholarship Program 887 Pretorius Street Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor not applicable not applicable not applicable South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Helene Loxton corner of Victoria and Ryneveld Streets Stellenbosch 7600 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lisa Visagie visagie.lisa@gmail.com +27824564622 corner of Victoria and Ryneveld Streets
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Consolidoc at Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Leslie Swartz lswartz@sun.ac.za +27824593559 corner of Victoria and Ryneveld Streets
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Professor at Department of Psychology Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Helene Loxton hsl@sun.ac.za +27218083417 corner of Victoria and Ryneveld Streets
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Associate Professor in Department of Psychology at Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data are available in an unpublished doctoral dissertation (Visagie, 2016) at http://scholar.sun.ac.za/handle/10019.1/100110 Study Protocol The data have already been shared Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://scholar.sun.ac.za/handle/10019.1/100110 Yes Data available in dissertation: article in process 03/06/2019 03/06/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://dx.doi.org/10.4102/ajod.v4i1.160
Changes to trial information