Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot

University of Exeter

Status: Not yet enrolling

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

Treatments: Behavioral: Zithandani Stepping Stones and Creating Futures

Study type: Interventional

Funder types: Other

Identifiers

NCT06975137

1633030

MR/X004090/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Participants will be recruited as heterosexual couples and participate in 14 sessions, each approximately 3 hours long, with between 4 and 6 other couples, focused on gender norms, livelihoods and communication.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Individual inclusion:

• 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

Joint inclusion criteria:

• 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

Exclusion criteria individuals is as follows:

• 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

Joint couples exclusion criteria

• Relationship is not public knowledge
• Have been together for less than 6 months

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Zithandani Stepping Stones and Creating Futures

Experimental group

Description:

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

Treatment:

Behavioral: Zithandani Stepping Stones and Creating Futures