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Intimate Partner ViolenceNCT05783336

Stepping Stones and Creating Futures Plus Pilot

A study testing Stepping Stones and Creating Futures Plus (SSCF+) in people with Intimate Partner Violence and Poverty, run by University of Exeter at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Intimate Partner Violence, Poverty
What is being tested?
Stepping Stones and Creating Futures Plus (SSCF+)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
1 siteSouth Africa
Study dates
24 May 2023to 28 Nov 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Normally resident in the community where recruiting
  • Aged 18-30 years old
  • Not in formal employment, or full-time education
  • Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
  • Able to provide informed consent

Who cannot join

  • Only in the community temporarily
  • Unable to provide informed consent
  • Under 18 years of age, or over 31 years old at point of recruitment
  • Unable to communicate in main study languages

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • South African Medical Research Council

    Durban

Other trials in South Africa

About this study

Official title: An Inter-disciplinary Approach to Understanding and Intervening on Contextual Factors That Shape HIV-risk for Young Women and Men in South Africa: Phase 2 - the Feasibility, Acceptability and Potential Effect Size of a Pilot Randomised Controlled Trial

The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The main questions it aims to answer are:

  • Is the intervention acceptable and feasible
  • What is the potential effect size on key outcomes of intimate partner violence

Participants will be randomised (1:1) to compare SSCF+ and a control arm to see if there are differences between the two on intimate partner violence.

Read the detailed description

Intimate partner violence is very common in South Africa, particularly urban informal settlements. We have co-developed an intervention, called Stepping Stones and Creating Futures Plus (SSCF+), which will be evaluated in women and men aged 18-25 years living in KwaZulu-Natal, South Africa.

This is a pilot randomised controlled trial and as such there is focus on understanding whether the intervention is acceptable (to participants), feasible to deliver, and the potential effect sizes we may see in a full trial.

Being tested
Stepping Stones and Creating Futures Plus (SSCF+)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stepping Stones and Creating Futures Plus (SSCF+)Behavioural

    Group-based intervention delivered to small friendship networks, by a facilitator.

Study groups in NCT05783336
Study groupRoleWhat they receive
SSCF+ExperimentalStepping Stones and Creating Futures Plus (SSCF+). Small group intervention, comprising approximately 15 sessions (each session ~3 hours), addressing gender, livelihoods, mental health.
Receives: Behavioral: Stepping Stones and Creating Futures Plus (SSCF+)
ControlNo interventionNo intervention control (wait-list)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Intimate Partner Violence

    Past 6 month experience (women) and perpetration (men) of physical IPV as assessed using WHO measure of IPV. This consists of 5 items of behaviourally specific experiences (e.g. slapped, hit) that occurred in the past 6-months. Response options are 'never', 'once', 'a few times' or 'many times'. Recoded as a binary based on the 5-items, with any 'positive' response classified as 'yes'.

    Measured: 6 months

  2. Sexual Intimate Partner Violence

    Past 6 month experience (women) and perpetration (men) of sexual IPV as assessed using WHO measure of IPV. This uses 3-items which are behaviourally specific (e.g. forced to have sex when did not want) that occurred in the past 6-months. Response options are 'never', 'once', 'a few times' or 'many times'. Recoded as a binary based on the 3-items, with any 'positive' response classified as 'yes'.

    Measured: 6 months

  3. Severe Intimate Partner Violence

    Past 6 month experience (women) and perpetration (men) of severe IPV as assessed using WHO IPV physical and sexual IPV scales. Comprising of behaviourally specific acts, specifically 5 physical and 3 sexual, that occurred in the past 6-months. Response options are 'never', 'once', 'a few times' or 'many times'. Recoded as a binary based on the 8-items, with any two 'positive' response classified as 'yes'.

    Measured: 6 months

Secondary outcomes (10)

  1. Depressive Symptoms

    Mean score of depressive symptoms as assessed by the Center for Epidemiology Studies Depression Scale (CESD) comprising 20 items, which are summed to create a score. Possible range 0-40 with higher scores indicating more depressive symptoms (bad).

    Measured: 6 months

  2. Post-traumatic-stress Symptoms

    Post traumatic stress symptoms experienced in past week as assessed through the Harvard Trauma Questionnaire (16 items). Items are summed and potential range is 0-48 and higher scores indicate more symptoms.

    Measured: 6 months

  3. Emotional Dysregulation

    Assessed via the Difficulties in Emotional Regulation Scale (DERS) short form, with 16 items, summed. Potential range is 16-80 and higher scores indicate greater difficulties in positively regulating emotions.

    Measured: 6 months

  4. Earnings

    Self-reported past month earnings (South African Rand)

    Measured: 6 months

  5. Savings

    Self-report past month savings (South African Rand)

    Measured: 6 months

  6. Hunger

    Past month food insecurity assessed through the 3 items of the Household Food Insecurity Access Scale (HFIAS). Items are summed with potential range from 3-12, with higher scores indicating more food insecurity/hunger.

    Measured: 6 months

  7. Livelihood Activities

    Frequency of livelihood strengthening activities in the past 3 months, assessed through seven items, drawn from the UN Multi-country Study of Men and Violence in Asia and the Pacific. The items were summed with potential range 0-28, with higher scores indicating a greater frequency of livelihood activities.

    Measured: 6 months

  8. Work Stress

    Experience of stress because of lack of work and money assessed through 4 items, drawn from the International Men and Gender Equality Survey (IMAGES). Items are summed with a potential range 4-16, with higher scores indicative of more stress.

    Measured: 6 months

  9. Work Shame

    Experience of shame because of lack of work and money assessed through 4 items, drawn from the International Men and Gender Equality Survey (IMAGES). Items are summed with a potential range 4-16, with higher scores indicative of more shame about lack of work.

    Measured: 6 months

  10. Capabilities

    Experience of capabilities assessed through 5 items of a modified ICECAP-A (ICEpop CAPability measure for Adults) scale. Items are summed with potential range from 0-20, higher scores are bad, as indicate reduced capabilities.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start24 May 2023
  3. Primary completion28 Nov 2023
  4. Study completion28 Nov 2023

Resources

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
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783336
Sponsor's protocol ID
EC023-10/2022
Status last verified
Jul 2026
First submitted
13 Mar 2023
Last updated
13 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data will be shared within 12 months of study completion on University of Exeter and South African Medical Research Council data repository.

Publications

  • Gibbs A, Washington L, Mkhwanazi S, Chirwa E, Khaula S, Shai NJ, Willan S, Batura N, Burgess R, Mnandi N, Simelane N, Jewkes R, Mannell J. Stepping Stones and Creating Futures Plus: A pilot randomised controlled trial of a co-developed intervention with young South Africans. PLOS Glob Public Health. 2025 Apr 23;5(4):e0004494. doi: 10.1371/journal.pgph.0004494. eCollection 2025.

    PubMed 40267104

Questions about this trial

What is this clinical trial studying?

A study testing Stepping Stones and Creating Futures Plus (SSCF+) in people with Intimate Partner Violence and Poverty, run by University of Exeter 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 5 inclusion and 4 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 13 Jul 2026. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Physical Intimate Partner Violence (time frame: 6 months). 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 NCT05783336, which also lists 1 linked publication.

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 13 Jul 2026.

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