South African Medical Research Council
Durban, South Africa
NCT Number: NCT05783336
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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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Durban, South Africa
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group-based intervention delivered to small friendship networks, by a facilitator.
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'.
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'.
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'.
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).
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.
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.
Time frame: 6 months
Self-reported past month earnings (South African Rand)
Time frame: 6 months
Self-report past month savings (South African Rand)
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.
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.
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.
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.
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.
University of Exeter
Other
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
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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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