Stepping Stones and Creating Futures Plus Pilot

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Intimate Partner Violence, Poverty

Intervention / Treatment
-----------------
* Behavioral: Stepping Stones and Creating Futures Plus (SSCF+)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSCF+<br>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+)<br>* Group-based intervention delivered to small friendship networks, by a facilitator.<br>|
| No Intervention: Control<br>No intervention control (wait-list) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Intimate Partner Violence | Past 6 month experience (women) and perpetration (men) of physical IPV as assessed using WHO measure of IPV (5 items, binary) | 6 months | 
| Sexual Intimate Partner Violence | Past 6 month experience (women) and perpetration (men) of sexual IPV as assessed using WHO measure of IPV (3 items) | 6 months | 
| Severe Intimate partner violence | Past 6 month experience (women) and perpetration (men) of severe IPV as assessed using WHO IPV scale (8 items, coded into a binary) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Mean score of depressive symptoms as assessed by the Center for Epidemiology Studies Depression Scale (CESD) comprising 20 items | 6 months | 
| Post-traumatic-stress symptoms | Post traumatic stress symptoms experienced in past week (mean) as assessed through the Harvard Trauma Questionnaire (16 items) | 6 months | 
| Emotional Dysregulation | Assessed via the Difficulties in Emotional Regulation Scale (DERS) short form, 16 items. Mean score. | 6 months | 
| Earnings | Self-reported past month earnings (South African Rand) | 6 months | 
| Savings | Self-report past month savings (South African Rand) | 6 months | 
| Hunger | Past month food insecurity assessed through the 3 items of the Household Food Insecurity Access Scale (HFIAS) | 6 months | 
| Livelihood Activities | Frequency of livelihood strengthening activities in the past 3 months, assessed through seven items | 6 months | 
| Work stress | Experience of stress because of lack of work and money assessed through 4 items | 6 months | 
| Work shame | Experience of shame because of lack of work and money assessed through 4 items | 6 months | 
| Capabilities | Experience of capabilities assessed through 5 items of a modified ICECAP scale | 6 months |