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CompletedNCT05783336Updated Jul 13, 2026Results posted

Stepping Stones and Creating Futures Plus Pilot

An interventional study of Stepping Stones and Creating Futures Plus (SSCF+) in Intimate Partner Violence and Poverty, sponsored by University of Exeter. Completed at 1 site in South Africa. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of Exeter · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intimate Partner Violence
  • Poverty
03

In context

Lead sponsor

University of Exeter is the lead sponsor of 138 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
325 participants (actual)

Study arms

  • Experimental
    SSCF+

    Stepping Stones and Creating Futures Plus (SSCF+). Small group intervention, comprising approximately 15 sessions (each session \~3 hours), addressing gender, livelihoods, mental health.

    Behavioral: Stepping Stones and Creating Futures Plus (SSCF+)

  • No intervention
    Control

    No intervention control (wait-list)

Interventions

  • BehavioralStepping Stones and Creating Futures Plus (SSCF+)

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

06

What researchers measure

Primary outcomes

  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'.

    Time frame: 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'.

    Time frame: 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'.

    Time frame: 6 months

Secondary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 6 months

  4. Earnings

    Self-reported past month earnings (South African Rand)

    Time frame: 6 months

  5. Savings

    Self-report past month savings (South African Rand)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 6 months

07

Results

Posted Jul 13, 2026

Participant flow

Recruitment 24 May - 15 June 2023. Community recruitment, using 'chain-link' approach, focused on friendship networks. Eligible participant identified in community, asked to recruit friends who are similar and match eligibility criteria (from 3-10). Once assessed for eligibility and provided informed consent, a friendship group becomes a 'cluster' for the intervention and the focus for randomisation and intervention delivery.

Participant flow — Overall Study
MilestoneSSCF+Control
Started157168
Completed155165
Not completed23

Outcome measures

PrimaryPhysical 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'.

Time frame:
6 months
Reported as:
Count of participants · Participants
Physical Intimate Partner Violence
ParticipantsWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Physical Intimate Partner Violence26412532
PrimarySexual 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'.

Time frame:
6 months
Reported as:
Count of participants · Participants
Sexual Intimate Partner Violence
ParticipantsWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Sexual Intimate Partner Violence17271717
PrimarySevere 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'.

Time frame:
6 months
Reported as:
Count of participants · Participants
Severe Intimate Partner Violence
ParticipantsWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Severe Intimate Partner Violence25372324
SecondaryDepressive 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).

Time frame:
6 months
Reported as:
Mean · Score on a scale
Depressive Symptoms
Score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Depressive Symptoms18.7 ± 11.324.5 ± 12.417.8 ± 9.116.6 ± 8.9
SecondaryPost-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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Post-traumatic-stress Symptoms
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Post-traumatic-stress Symptoms13.8 ± 10.218.0 ± 12.113.0 ± 8.112.1 ± 8.0
SecondaryEmotional 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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Emotional Dysregulation
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Emotional Dysregulation31.2 ± 12.235.0 ± 13.629.9 ± 11.430.5 ± 9.9
SecondaryEarnings

Self-reported past month earnings (South African Rand)

Time frame:
6 months
Reported as:
Mean · South African Rand (ZAR)
Earnings
South African Rand (ZAR)Women: SSCF+Women: ControlMen: SSCF+Men: Control
Earnings325 (150 to 900)200 (0 to 500)400 (200 to 1200)350 (70 to 700)
SecondarySavings

Self-report past month savings (South African Rand)

Time frame:
6 months
Reported as:
Mean · South African Rand (ZAR)
Savings
South African Rand (ZAR)Women: SSCF+Women: ControlMen: SSCF+Men: Control
Savings150 (0 to 300)0 (0 to 200)50 (0 to 200)50 (0 to 400)
SecondaryHunger

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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Hunger
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Hunger6.4 ± 2.87.4 ± 2.56.8 ± 2.36.9 ± 2.5
SecondaryLivelihood 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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Livelihood Activities
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Livelihood Activities12.0 ± 5.112.2 ± 5.511.7 ± 4.811.4 ± 4.8
SecondaryWork 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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Work Stress
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Work Stress12.6 ± 2.412.1 ± 2.812.0 ± 2.811.3 ± 2.4
SecondaryWork 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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Work Shame
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Work Shame10.1 ± 2.710.6 ± 2.210.3 ± 2.39.7 ± 2.3
SecondaryCapabilities

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.

Time frame:
6 months
Reported as:
Mean · score on a scale
Capabilities
score on a scaleWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Capabilities8.9 ± 2.810.8 ± 3.29.1 ± 3.08.7 ± 2.6

Adverse events

Collected over From enrolment, through to endline follow up, at approximately 6 months after baseline.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Women: SSCF+0/73 (0%)0/73 (0%)0/73 (0%)
Women: Control0/89 (0%)2/89 (2.2%)0/89 (0%)
Men: SSCF+0/84 (0%)0/84 (0%)0/84 (0%)
Men: Control1/79 (1.3%)0/79 (0%)0/79 (0%)
Most frequent serious events
Most frequent serious events
EventWomen: SSCF+Women: ControlMen: SSCF+Men: Control
Violence experiencedSocial circumstances0/731/890/840/79
Threat to harmSocial circumstances0/731/890/840/79

Baseline characteristics

Age, Continuous
Age, Continuous(years)SSCF+ControlTotal
Mean23.7 (18 to 30)23.5 (18 to 30)23.6 (18 to 30)
Sex: Female, Male
Sex: Female, Male(Participants)SSCF+ControlTotal
Female7389162
Male8479163
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)SSCF+ControlTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)SSCF+ControlTotal
South Africa157168325
08

Study locations

1 site
  • South African Medical Research Council
    Durban, South Africa
09

References and documents

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 ↗

Study documents

  • Protocol, analysis plan and consent form · Nov 28, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymised data will be shared within 12 months of study completion on University of Exeter and South African Medical Research Council data repository.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05783336
Lead sponsor
University of Exeter
Collaborators
Medical Research Council, South Africa, University College, London
Responsible party
Andrew Gibbs (Senior Lecturer, University of Exeter) — Principal investigator
First posted
Mar 24, 2023
Start date
May 24, 2023
Primary completion
Nov 28, 2023
Completion
Nov 28, 2023
Results posted
Jul 13, 2026
Last update
Jul 13, 2026

Study contacts

Rachel Jewkes
principal investigator · Medical Research Council, South Africa
Andrew Gibbs
principal investigator · University of Exeter
Jenevieve Mannell
principal investigator · University College, London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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