Partner of Victim of Physical AbuseNCT02349321
Skhokho Supporting Success: A Cluster RCT of a Multi-faceted, School-based IPV Prevention Intervention in South Africa
A study testing Skhokho Supporting Success for Schools and Skhokho Supporting Success for Families in people with Partner of Victim of Physical Abuse, run by Medical Research Council, South Africa.
Trial summary
Development and evaluation of a multi-faceted school-based intervention to prevent intimate partner violence among Grade 8 high school students in South Africa Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Partner of Victim of Physical Abuse
- What is being tested?
- Skhokho Supporting Success for Schools and Skhokho Supporting Success for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,192 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2013to 30 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- NONE
About this study
Official title: Skhokho Supporting Success: A Cluster Randomised Controlled Trial of a Multi-faceted, School-based Intimate Partner Violence Primary Prevention Intervention in Gauteng, South Africa
Development and evaluation of a multi-faceted school-based intervention to prevent intimate partner violence among Grade 8 high school students in South Africa
Read the 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.
- Conditions
- Partner of Victim of Physical Abuse
- Being tested
- Skhokho Supporting Success for Schools, Skhokho Supporting Success for Families
- Keywords
- physical or sexual intimate partner violence, adolescents, primary prevention, randomised controlled trial, school, South Africa, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skhokho Supporting Success for SchoolsBehavioural
All information describing each facet of the intervention are included in the arm/group descriptions.
Skhokho Supporting Success for FamiliesBehavioural
All information describing each facet of the intervention are included in the arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| School Strengthening | Experimental | 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. Receives: Behavioral: Skhokho Supporting Success for Schools |
| School + Family Strengthening | Experimental | 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. Receives: Behavioral: Skhokho Supporting Success for Schools; Behavioral: Skhokho Supporting Success for Families |
| Arm 3: Control (Delayed Intervention) | No 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 being measured
The primary outcome is the main question the study is designed to answer.
The incidence of IPV (perpetration of physical or sexual IPV for boys and victimisation for girls)
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).
Measured: Over 18 months of the study
The incidence of severe physical and sexual IPV
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).
Measured: Over the last 12 months of the study
Secondary outcomes (10)
Child-caregiver communication scores
difference in scores derived through summing 5 questions
Measured: 18 month follow up
Childhood trauma scale scores
Difference in scores derived through summing 15 items
Measured: 18 month follow up
The incidence of non-partner rape victimisation and perpetration
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)
Measured: Over 18 months of the study
Childhood trauma exposure incidence
Positive affirmation of teens and environment at home Emotional neglect Physical abuse Sexual abuse
Measured: 18 month follow up
Bullying at school score
Comparison of scores across 3 items
Measured: 18 month follow up
Score for communication with girlfriend/boyfriend
Difference in scores measured through summing responses to 5 items
Measured: 18 month follow up
The incidence of emotional Intimate Partner Violence perpetration (for boys) and victimisation (for girls)
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).
Measured: 18 months follow up
the incidence of delinquency
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
Measured: 18-month follow up
Depression and anxiety score measured on the Child Depression Inventory
The difference in scores
Measured: 18-month follow up
Gender attitudes score measured across 5 items
the difference in scores
Measured: 18-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start9 Feb 2013
- Primary completion30 Sep 2013
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Partner of Victim of Physical AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Jewkes, Medical Research Council, South Africa
- Investigators
- Rachel Jewkes, MD, Principal investigator, SA Medical Research CouncilAnik Gevers, PhD, Principal investigator, SA Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349321
- Sponsor's protocol ID
- ECO22-9
- Status last verified
- Jul 2017
- First submitted
- 16 Jan 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31661530Shamu 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.
PubMed 26637828
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skhokho Supporting Success: A Cluster Randomised Controlled Trial of a Multi-faceted, School-based Intimate Partner Violence Primary Prevention Intervention in Gauteng, South Africa
- ClinicalTrials.gov ID
- NCT02349321
- Acronym / sponsor ID
- ECO22-9
- Conditions
- Partner of Victim of Physical Abuse
- Keywords
- physical or sexual intimate partner violence, adolescents, primary prevention, randomised controlled trial, school, South Africa, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,192 participants (estimated)
- Lead sponsor
- Medical Research Council, South AfricaUniversity, hospital or other
- Study start
- 9 Feb 2013 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development and evaluation of a multi-faceted school-based intervention to prevent intimate partner violence among Grade 8 high school students in South Africa
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School Strengthening | Experimental | Behavioral: Skhokho Supporting Success for SchoolsSkhokho 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. |
| School + Family Strengthening | Experimental | Behavioral: Skhokho Supporting Success for Schools, Behavioral: Skhokho Supporting Success for FamiliesSkhokho 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. |
| Arm 3: Control (Delayed Intervention) | No 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skhokho Supporting Success for SchoolsAll information describing each facet of the intervention are included in the arm/group descriptions. | Behavioural | School + Family Strengthening, School Strengthening |
| Skhokho Supporting Success for FamiliesAll information describing each facet of the intervention are included in the arm/group descriptions. | Behavioural | School + Family Strengthening |
Primary outcome
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).
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).
10 secondary outcomes
Child-caregiver communication scores
Time frame: 18 month follow up
Childhood trauma scale scores
Time frame: 18 month follow up
The incidence of non-partner rape victimisation and perpetration
Time frame: Over 18 months of the study
Childhood trauma exposure incidence
Time frame: 18 month follow up
Bullying at school score
Time frame: 18 month follow up
Score for communication with girlfriend/boyfriend
Time frame: 18 month follow up
The incidence of emotional Intimate Partner Violence perpetration (for boys) and victimisation (for girls)
Time frame: 18 months follow up
the incidence of delinquency
Time frame: 18-month follow up
Depression and anxiety score measured on the Child Depression Inventory
Time frame: 18-month follow up
Gender attitudes score measured across 5 items
Time frame: 18-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 31661530Jewkes 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.
- Derived from this study: PubMed 26637828Shamu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Jewkes, MD principal investigator
SA Medical Research Council
Anik Gevers, PhD principal investigator
SA Medical Research Council
Questions about this trial
What is this clinical trial studying?
A study testing Skhokho Supporting Success for Schools and Skhokho Supporting Success for Families in people with Partner of Victim of Physical Abuse, run by Medical Research Council, South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of IPV (perpetration of physical or sexual IPV for boys and victimisation for girls) (time frame: Over 18 months of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.