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Skhokho Supporting Success: A Cluster RCT of a Multi-faceted, School-based IPV Prevention Intervention in South Africa

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ClinicalTrials.gov Identifier: NCT02349321
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Rachel Jewkes, Medical Research Council, South Africa

Brief 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

Condition or disease Intervention/treatment Phase
Partner of Victim of Physical Abuse Behavioral: Skhokho Supporting Success for Schools Behavioral: Skhokho Supporting Success for Families Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 9, 2013
Actual Primary Completion Date : September 30, 2013
Actual Study Completion Date : May 30, 2016

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.
Behavioral: Skhokho Supporting Success for Schools
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.

Behavioral: Skhokho Supporting Success for Schools
All information describing each facet of the intervention are included in the arm/group descriptions.

Behavioral: Skhokho Supporting Success for Families
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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Child-caregiver communication scores [ Time Frame: 18 month follow up ]
    difference in scores derived through summing 5 questions

  2. Childhood trauma scale scores [ Time Frame: 18 month follow up ]
    Difference in scores derived through summing 15 items

  3. 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)

  4. Childhood trauma exposure incidence [ Time Frame: 18 month follow up ]
    Positive affirmation of teens and environment at home Emotional neglect Physical abuse Sexual abuse

  5. Bullying at school score [ Time Frame: 18 month follow up ]
    Comparison of scores across 3 items

  6. Score for communication with girlfriend/boyfriend [ Time Frame: 18 month follow up ]
    Difference in scores measured through summing responses to 5 items

  7. 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).

  8. 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

  9. Depression and anxiety score measured on the Child Depression Inventory [ Time Frame: 18-month follow up ]
    The difference in scores

  10. Gender attitudes score measured across 5 items [ Time Frame: 18-month follow up ]
    the difference in scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349321


Sponsors and Collaborators
Medical Research Council, South Africa
Investigators
Layout table for investigator information
Principal Investigator: Rachel Jewkes, MD SA Medical Research Council
Principal Investigator: Anik Gevers, PhD SA Medical Research Council

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rachel Jewkes, Professor Rachel K. Jewkes and Dr Anik Gevers, Medical Research Council, South Africa
ClinicalTrials.gov Identifier: NCT02349321    
Other Study ID Numbers: ECO22-9
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Rachel Jewkes, Medical Research Council, South Africa:
physical or sexual intimate partner violence
adolescents
primary prevention
randomised controlled trial
school
South Africa
parenting