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Completed

NCT Number: NCT05783336

Stepping Stones and Creating Futures Plus Pilot

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South African Medical Research Council

Durban, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Stepping Stones and Creating Futures Plus (SSCF+)

Behavioral

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

Primary outcomes

  1. Physical Intimate Partner Violence

    Time frame: 6 months

    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'.

  2. Sexual Intimate Partner Violence

    Time frame: 6 months

    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'.

  3. Severe Intimate Partner Violence

    Time frame: 6 months

    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'.

Secondary outcomes

  1. Depressive Symptoms

    Time frame: 6 months

    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).

  2. Post-traumatic-stress Symptoms

    Time frame: 6 months

    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.

  3. Emotional Dysregulation

    Time frame: 6 months

    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.

  4. Earnings

    Time frame: 6 months

    Self-reported past month earnings (South African Rand)

  5. Savings

    Time frame: 6 months

    Self-report past month savings (South African Rand)

  6. Hunger

    Time frame: 6 months

    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.

  7. Livelihood Activities

    Time frame: 6 months

    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.

  8. Work Stress

    Time frame: 6 months

    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.

  9. Work Shame

    Time frame: 6 months

    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.

  10. Capabilities

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Medical Research Council, South Africa
  • University College, London

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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