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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05783336
Other study ID # EC023-10/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2023
Est. completion date November 28, 2023

Study information

Verified date May 2024
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 323
Est. completion date November 28, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stepping Stones and Creating Futures Plus (SSCF+)
Group-based intervention delivered to small friendship networks, by a facilitator.

Locations

Country Name City State
South Africa South African Medical Research Council Durban

Sponsors (3)

Lead Sponsor Collaborator
University of Exeter Medical Research Council, South Africa, University College, London

Country where clinical trial is conducted

South Africa, 

Outcome

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