Stepping Stones and Creating Futures Plus Pilot

NCT ID: NCT05783336

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2023-11-28

Brief Summary

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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

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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.

Conditions

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Intimate Partner Violence Poverty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SSCF+

Stepping Stones and Creating Futures Plus (SSCF+). Small group intervention, comprising approximately 15 sessions (each session \~3 hours), addressing gender, livelihoods, mental health.

Group Type EXPERIMENTAL

Stepping Stones and Creating Futures Plus (SSCF+)

Intervention Type BEHAVIORAL

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

Control

No intervention control (wait-list)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stepping Stones and Creating Futures Plus (SSCF+)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Andrew Gibbs

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Jewkes

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council, South Africa

Andrew Gibbs

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Jenevieve Mannell

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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South African Medical Research Council

Durban, , South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type DERIVED
PMID: 40267104 (View on PubMed)

Other Identifiers

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EC023-10/2022

Identifier Type: -

Identifier Source: org_study_id

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