- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349321
Skhokho Supporting Success: A Cluster RCT of a Multi-faceted, School-based IPV Prevention Intervention in South Africa
Skhokho Supporting Success: A Cluster Randomised Controlled Trial of a Multi-faceted, School-based Intimate Partner Violence Primary Prevention Intervention in Gauteng, South Africa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary prevention of intimate partner violence among young men and women requires an intervention which addresses the underlying driving factors of such violence operating at different ecological levels.That is, interventions need to address factors impacting directly on youth and their family relationships, school as an institutional setting. In the school, holistic interventions strengthen the curriculum and teaching, but also the broader environment of learning, including addressing positive discipline and the culture of the school. In order to prevent violence, interventions need to build gender equality, challenge the normative use of violence in schools and homes (e.g., corporal punishment), strengthen teen-adult relationships and communication, and build negotiation and conflict resolution skills, as well as addressing stress and coping.
A three-arm, cluster randomised controlled trial based in high schools in Gauteng, South Africa is evaluating such a multi-faceted primary prevention intervention. This intervention includes school strengthening components for learners and educators, which includes providing a teaching materials for the grade 8 life orientation (LO) curriculum (which covers gender and violence), training teachers in LO teaching, training staff on positive discipline and establishing learner clubs. A second intervention seeks to strengthen families and is a workshop based intervention delivered over 4 day long sessions for a parent or caregiver and their grade 8 adolescent.
The intervention is being evaluated in a three arm randomised controlled trial, with school-level randomisation involving 24 schools. One is a delayed intervention control arm, two arms have the school strengthening intervention and one arm additionally have the family strengthening intervention.
The outcomes will be addressed using qualitative and quantitative methods with data collected from Grade 8 learners (the primary outcome group), school educators and administrators, and parents/caregivers of Grade 8s. These measures will be conducted pre-intervention and at 6, 12, and 18 month follow up periods. In addition, an economic costing evaluation will be conducted.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- LEARNER/TEEN PARTICIPANTS: enrolled in Grade 8 in one of the study schools; informed consent from parent/guardian to participate in study
- EDUCATOR PARTICIPANTS: currently employed/working as an educator (of any group of learners) at one of the study schools
- PARENT/CAREGIVER PARTICIPANTS: the male or female parent/caregiver/guardian of a Grade 8 learner in Arm 2 schools
Exclusion Criteria:
NONE
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: School Strengthening
Skhokho Supporting Success for Schools: (a) Full year Grade 8 Life Orientation Learner Workbook (following the national curriculum), Educator Guide, and LO Educator support workshops; (b) Educator workshops including values, positive discipline skills, adolescent development, and stress and coping; (c) Learner club workshops (Grade 8s-11s) including creating change for a safe and vibrant school community, human rights at school, communication and conflict resolution skills, and stress and coping.
|
All information describing each facet of the intervention are included in the arm/group descriptions.
|
Experimental: School + Family Strengthening
Skhokho Supporting Success for Schools: See description above. Skhokho Supporting Success for Families: Participatory four-day workshop for parents/caregivers and their young adolescent children including parallel and joint dialogue sessions. This workshop aims to promote supportive, open relationships between parents/caregivers and their teens and includes communication, negotiation and conflict resolution skills; positive discipline skills; challenging traditional gender constructions; understanding the impact of child abuse; stress and coping. |
All information describing each facet of the intervention are included in the arm/group descriptions.
All information describing each facet of the intervention are included in the arm/group descriptions.
|
No Intervention: Arm 3: Control (Delayed Intervention)
This group will continue with "treatment as usual" (i.e: school services, activities, and textbooks without specialised intervention).
At the end of primary data collection, these schools will be eligible to receive the Schools Strengthening Intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of IPV (perpetration of physical or sexual IPV for boys and victimisation for girls)
Time Frame: Over 18 months of the study
|
Any participant who responds affirmatively to any one of the five questions on physical intimate partner violence or one question on sexual intimate partner violence at the 6, 12 or 18 month data collection points will be deemed to be an incident case of IPV victimisation (if female) or perpetration (if male).
|
Over 18 months of the study
|
The incidence of severe physical and sexual IPV
Time Frame: Over the last 12 months of the study
|
Any participant who responds affirmatively to more than one of the five questions on physical intimate partner violence and/or one question on sexual intimate partner violence at the 12 or 18 month data collection points will be deemed to be an incident case of severe IPV victimisation (if female) or perpetration (if male).
|
Over the last 12 months of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child-caregiver communication scores
Time Frame: 18 month follow up
|
difference in scores derived through summing 5 questions
|
18 month follow up
|
Childhood trauma scale scores
Time Frame: 18 month follow up
|
Difference in scores derived through summing 15 items
|
18 month follow up
|
The incidence of non-partner rape victimisation and perpetration
Time Frame: Over 18 months of the study
|
Any participant who responds affirmatively to any of the non-partner rape questions (2 for girls and 4 for boys) will be deemed to be an incident case of non-partner rape victimisation (if female) and perpetration (if male)
|
Over 18 months of the study
|
Childhood trauma exposure incidence
Time Frame: 18 month follow up
|
Positive affirmation of teens and environment at home Emotional neglect Physical abuse Sexual abuse
|
18 month follow up
|
Bullying at school score
Time Frame: 18 month follow up
|
Comparison of scores across 3 items
|
18 month follow up
|
Score for communication with girlfriend/boyfriend
Time Frame: 18 month follow up
|
Difference in scores measured through summing responses to 5 items
|
18 month follow up
|
The incidence of emotional Intimate Partner Violence perpetration (for boys) and victimisation (for girls)
Time Frame: 18 months follow up
|
Any participant who responds affirmatively to any one of the three questions on emotional intimate partner violence at the 6, 12 or 18 month data collection points will be deemed to be an incident case of emotional IPV victimisation (if female) or perpetration (if male).
|
18 months follow up
|
the incidence of delinquency
Time Frame: 18-month follow up
|
Any participant who responds affirmatively to any one of five questions on delinquency at the 6, 12 or 18 months data collection points will be deemed to be an incident case of delinquency
|
18-month follow up
|
Depression and anxiety score measured on the Child Depression Inventory
Time Frame: 18-month follow up
|
The difference in scores
|
18-month follow up
|
Gender attitudes score measured across 5 items
Time Frame: 18-month follow up
|
the difference in scores
|
18-month follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rachel Jewkes, MD, SA Medical Research Council
- Principal Investigator: Anik Gevers, PhD, SA Medical Research Council
Publications and helpful links
General Publications
- Jewkes R, Gevers A, Chirwa E, Mahlangu P, Shamu S, Shai N, Lombard C. RCT evaluation of Skhokho: A holistic school intervention to prevent gender-based violence among South African Grade 8s. PLoS One. 2019 Oct 29;14(10):e0223562. doi: 10.1371/journal.pone.0223562. eCollection 2019.
- Shamu S, Gevers A, Mahlangu BP, Jama Shai PN, Chirwa ED, Jewkes RK. Prevalence and risk factors for intimate partner violence among Grade 8 learners in urban South Africa: baseline analysis from the Skhokho Supporting Success cluster randomised controlled trial. Int Health. 2016 Jan;8(1):18-26. doi: 10.1093/inthealth/ihv068. Epub 2015 Dec 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ECO22-9
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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