Clinical trial NCT06975137: Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot
Official title: Adapting an Evidenced-based Intervention to Reduce IPV for Use Among Young Heterosexual Couples in South Africa - Zithandani SSCF - Phase 2: Pilot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: University College, London
name: Project Empower
First posted: 2025-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. 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.


Eligibility 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

Primary outcomes:
measure: Physical IPV
timeFrame: 6 months post baseline
measure: Sexual IPV
timeFrame: 6 months post baseline
measure: Emotional IPV
timeFrame: 6 months post baseline
measure: Economic IPV
timeFrame: 6 months post baseline
Secondary outcomes:
measure: Gender Attitudes
timeFrame: 6 months post baseline
measure: Violence towards children
timeFrame: 6 months post baseline
measure: Trust in relationship/partner measured using the Dyadic Trust scale
timeFrame: 6 months post baseline
measure: Relationship Satisfaction
timeFrame: 6 months post baseline
measure: Fear of Emotional Intimacy
timeFrame: 6 months post baseline
measure: Empathy for Partner assessed with the Interpersonal Reactivity Index for Couples (IRIC) scale.
timeFrame: 6 months post baseline
measure: Sexual Intimacy
timeFrame: 6 months post baseline
measure: Communication with partner assessed using the Communications Pattern Questionnaire
timeFrame: 6 months post baseline
measure: Depressive Symptoms assessed using the Patient Health Questionnaire - 9 (PHQ9)
timeFrame: 6 months post baseline
measure: Anxiety Symptoms assessed using the Generalised Anxiety Disorder 7 (GAD7) questionnaire
timeFrame: 6 months post baseline
measure: Emotional Dysregulation assessed using the Difficulties in Emotional Regulation Scale 16
timeFrame: 6 months post baseline
measure: Alcohol Consumption in past 3 months, assessed with modified Alcohol use disorders identification test consumption (AUDIT C)
timeFrame: 6 months post baseline
measure: Earnings in past month
timeFrame: 6 months post baseline
measure: Money participant saved in past month
timeFrame: 6 months post baseline
measure: Hunger in the past month
timeFrame: 6 months post baseline
measure: Frequency of work efforts
timeFrame: 6 months post baseline
Other outcomes:
measure: Individual Attendance at Intervention
timeFrame: From enrollment to end of intervention deliver at ~7 weeks
measure: Couples Attendance at Intervention
timeFrame: From enrollment to end of intervention deliver at ~7 weeks
Locations:
city: Durban
country: South Africa
facility: South African Medical Research Council
Study officials:
References: