NCT05783336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

March 13, 2023

Last Update Submit

May 7, 2024

Conditions

Intimate Partner ViolencePoverty

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Depressive symptoms

    6 months

  • Post-traumatic-stress symptoms

    6 months

  • Emotional Dysregulation

    6 months

  • Earnings

    6 months

  • Savings

    6 months

  • +5 more secondary outcomes

Study Arms (2)

SSCF+

EXPERIMENTAL

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+)

Control

NO INTERVENTION

No intervention control (wait-list)

Interventions

Stepping Stones and Creating Futures Plus (SSCF+)BEHAVIORAL

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

SSCF+

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South African Medical Research Council

Durban, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 40267104DERIVED

Study Officials

  • Rachel Jewkes

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

  • Andrew Gibbs

    University of Exeter

    PRINCIPAL INVESTIGATOR

  • Jenevieve Mannell

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

May 24, 2023

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared within 12 months of study completion on University of Exeter and South African Medical Research Council data repository.

Shared Documents
STUDY PROTOCOL
Time Frame
12 months from completion of study
Access Criteria
Freely available

Locations

ZA(1)