Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot

NCT06975137 | Not Yet Recruiting

• 2 other identifiers: 1633030MR/X004090/1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this uncontrolled intervention study is to assess whether Zithandani Stepping Stones and Creating Futures is feasible to deliver, acceptable for participants, safe for participants and to estimate effect sizes, in young (ages 18-40 years) heterosexual couples, living in urban informal settlements in eThekwini Municipality, South Africa. The main questions it aims to answer are:

1. 1.Is Zithandani SSCF feasible to deliver to young couples, and what are the barriers and opportunities in intervention delivery?
2. 2.Is Zithandani SSCF acceptable to participants? What do they like and what do they not like about the intervention?
3. 3.Is Zithandani SSCF safe for female participants and do they engage adequately?
4. 4.Does Zithandani SSCF show indication of positive change on key indicators and what are the effect sizes?

Conditions

Intimate Partner Violence (IPV); Earning Outcomes; Mental Health; Couple Communication; Couple Conflict; Couples; Livelihoods

Keywords

informal settlements; South Africa; couples; intimate partner violence; couples communication; mental health; livelihoods

Outcome Measures

Primary Outcomes (4)

• Physical IPV

  Self-reports focused on men's perpetration and women's experience of physical intimate partner violence in the past 3 months, based on the WHO Violence Against Women Module - with 5 items. Recoded as a binary (yes/no)

  6 months post baseline

• Sexual IPV

  Self-reports focused on men's perpetration and women's experience of sexual intimate partner violence in the past 3 months, based on the WHO Violence Against Women Module - with 3 items. Recoded as a binary (yes/no)

  6 months post baseline

• Emotional IPV

  Self-reports focused on men's perpetration and women's experience of sexual intimate partner violence in the past 3 months, based on the WHO Violence Against Women Module - with 8 items. Recoded as a binary (yes/no)

  6 months post baseline

• Economic IPV

  Self-reports focused on men's perpetration and women's experience of sexual intimate partner violence in the past 3 months, based on the WHO Violence Against Women Module - with 7 items. Recoded as a binary (yes/no)

  6 months post baseline

Secondary Outcomes (16)

• Gender Attitudes

  6 months post baseline

• Violence towards children

  6 months post baseline

• Trust in relationship/partner measured using the Dyadic Trust scale

  6 months post baseline

• Relationship Satisfaction

  6 months post baseline

• Fear of Emotional Intimacy

  6 months post baseline

Other Outcomes (2)

• Individual Attendance at Intervention

  From enrollment to end of intervention deliver at ~7 weeks

• Couples Attendance at Intervention

  From enrollment to end of intervention deliver at ~7 weeks

Study Arms (1)

Zithandani Stepping Stones and Creating Futures

EXPERIMENTAL

Couples intervention delivered in groups of 4-7 heterosexual couples.

Behavioral: Zithandani Stepping Stones and Creating Futures

Interventions

Zithandani Stepping Stones and Creating Futures BEHAVIORAL

Delivered to heterosexual couples. 14 group based sessions, with each session lasting approximately 3 hours. Sessions are delivered by two trained facilitators. Intervention focused on transforming gender norms, strengthening communication, reducing symptoms of poor mental health and improving relationship dynamics. Mixture of couples focused, same-gender discussions, and whole group discussions.

Zithandani Stepping Stones and Creating Futures

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-40 years,
• Reside in the selected community
• Not in full time permanent employment, or in full-time education
• Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
• Able and willing to provide informed consent to participate
• Be a heterosexual couple
• Been together in a relationship for a minimum of 6 months
• Relationship is public knowledge
• Willing to participate in an intervention

You may not qualify if:

• Under 18 or 41+ years old
• Planning on leaving the community in the next 3 months
• Unable or unwilling to provide informed consent
• Unable to communicate in the main study languages
• Relationship is not public knowledge
• Have been together for less than 6 months

Sponsors & Collaborators

• University of Exeter: lead
• Medical Research Council, South Africa: collaborator
• University College, London: collaborator
• Project Empower: collaborator

Study Sites (1)

South African Medical Research Council

Durban, South Africa

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Andrew Gibbs

CONTACT

+44 (0)1392 722179; a.gibbs@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after study completion.
• Access Criteria: Free to download once registered on appropriate sites.

Locations

ZA (1)