Physical ViolencePhase 2NCT03257176
Stepping Stones and Creating Futures Intervention Pilot
A Phase 2 study testing Stepping Stones and Creating Futures in people with Physical Violence and Sexual Violence, run by University of KwaZulu at 1 site in South Africa.
Trial summary
This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Violence, Sexual Violence, Livelihoods
- What is being tested?
- Stepping Stones and Creating Futures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 May 2012to 30 Jul 2013
- Phase
- Phase 2
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18
- Mentally competent
- Able to communicate in English, Zulu, or Xhosa
- Normally resident in the informal settlement
Who cannot join
- Over 30
- Unable to do informed consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gender and Health Research Unit, South African Medical Research Council
Durban, KwaZulu-Natal, 4001
About this study
This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality.
- Conditions
- Physical Violence, Sexual Violence, Livelihoods
- Being tested
- Stepping Stones and Creating Futures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping Stones and Creating FuturesBehavioural
21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.
| Study group | Role | What they receive |
|---|---|---|
| Stepping Stones and Creating Futures | Experimental | Receive the 21 session intervention Receives: Behavioral: Stepping Stones and Creating Futures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past three month physical IPV perpetration (men) and experience (women)
Physical intimate partner violence is assessed using five items based on the WHO VAW scale, asking about perpetration (men) and experience (women) of these five behaviourally specific actions in the past three months. A positive response to any of the five items leads to a person being classified as perpetrating (men) and experiencing (women) physical IPV in the past three months.
Measured: 12 months post baseline
Past three month sexual IPV perpetration (men) and experience (women)
Sexual intimate partner violence is assessed using three items based on the WHO VAW scale for sexual IPV. Questions are asked for the past three month perpetration (men) and experience (women). A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past three months.
Measured: 12 months post baseline
Earnings in past month
A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands and a continuous scale.
Measured: 12 months post baseline
Secondary outcomes (6)
Work stress
4 items ask about work stress because of a lack of work. Responses are on a likert scale.
Measured: 12 months post baseline
Feelings about work shame
4 items ask about shame because of type and lack of work. Responses are on a likert scale.
Measured: 12 months post baseline
Gender attitudes
Modified gender equitable men's scale assess participant's gender attitudes.
Measured: 12 months post baseline
Controlling behaviours
Controlling behaviours are assessed using a modified Sexual Relationship Power (SRP) scale. Men's control of female sexual partner's and women's experience of controlling behaviours from a male partner.
Measured: 12 months post baseline
Condom use at last sex
Single item asking about condom use at last sex
Measured: 12 months post baseline
Hunger in the past month
Single item assesses hunger in the past month
Measured: 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start2 May 2012
- Primary completion30 Jul 2013
- Study completion30 Jul 2013
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 Physical ViolenceStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Project Empower
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257176
- Sponsor's protocol ID
- HSS/0789/011
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059.
PubMed 26590246Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325.
PubMed 25544716
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepping Stones and Creating Futures Intervention Pilot
- ClinicalTrials.gov ID
- NCT03257176
- Acronym / sponsor ID
- HSS/0789/011
- Conditions
- Physical Violence, Sexual Violence, Livelihoods
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Project Empower
- Study start
- 2 May 2012 (actual)
- Primary completion
- 30 Jul 2013 (actual)
- Study completion
- 30 Jul 2013 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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.
This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stepping Stones and Creating Futures | Experimental | Behavioral: Stepping Stones and Creating FuturesReceive the 21 session intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Over 18
- Mentally competent
- Able to communicate in English, Zulu, or Xhosa
- Normally resident in the informal settlement
Key exclusion criteria (2 listed)
- Over 30
- Unable to do informed consent
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 |
|---|---|---|
| Stepping Stones and Creating Futures21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods. | Behavioural | Stepping Stones and Creating Futures |
Primary outcome
Past three month physical IPV perpetration (men) and experience (women)
Time frame: 12 months post baseline
Physical intimate partner violence is assessed using five items based on the WHO VAW scale, asking about perpetration (men) and experience (women) of these five behaviourally specific actions in the past three months. A positive response to any of the five items leads to a person being classified as perpetrating (men) and experiencing (women) physical IPV in the past three months.
Past three month sexual IPV perpetration (men) and experience (women)
Time frame: 12 months post baseline
Sexual intimate partner violence is assessed using three items based on the WHO VAW scale for sexual IPV. Questions are asked for the past three month perpetration (men) and experience (women). A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past three months.
Earnings in past month
Time frame: 12 months post baseline
A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands and a continuous scale.
6 secondary outcomes
Work stress
Time frame: 12 months post baseline
Feelings about work shame
Time frame: 12 months post baseline
Gender attitudes
Time frame: 12 months post baseline
Controlling behaviours
Time frame: 12 months post baseline
Condom use at last sex
Time frame: 12 months post baseline
Hunger in the past month
Time frame: 12 months post baseline
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 22 Aug 2017.
- Background: PubMed 26590246Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059.
- Results publication: PubMed 25544716Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stepping Stones and Creating Futures in people with Physical Violence and Sexual Violence, run by University of KwaZulu at 1 site in 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 4 inclusion and 2 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Past three month physical IPV perpetration (men) and experience (women) (time frame: 12 months post baseline). The study lists 3 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 NCT03257176, 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 22 Aug 2017.