Intimate Partner Violence (IPV)NCT06975137
Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot
A study testing Zithandani Stepping Stones and Creating Futures in people with Intimate Partner Violence (IPV) and Earning Outcomes, run by University of Exeter at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence (IPV), Earning Outcomes, Mental Health
- What is being tested?
- Zithandani Stepping Stones and Creating Futures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Jul 2025to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Adapting an Evidenced-based Intervention to Reduce IPV for Use Among Young Heterosexual Couples in South Africa - Zithandani SSCF - Phase 2: Pilot
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:
- Is Zithandani SSCF feasible to deliver to young couples, and what are the barriers and opportunities in intervention delivery?
- Is Zithandani SSCF acceptable to participants? What do they like and what do they not like about the intervention?
- Is Zithandani SSCF safe for female participants and do they engage adequately?
- 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.
- Conditions
- Intimate Partner Violence (IPV), Earning Outcomes, Mental Health, Couple Communication, Couple Conflict, Couples
- Being tested
- Zithandani Stepping Stones and Creating Futures
- Keywords
- informal settlements, South Africa, couples, intimate partner violence, couples communication, mental health, livelihoods
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zithandani Stepping Stones and Creating FuturesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Zithandani Stepping Stones and Creating Futures | Experimental | Couples intervention delivered in groups of 4-7 heterosexual couples. Receives: Behavioral: Zithandani Stepping Stones and Creating Futures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months post baseline
Secondary outcomes (16)
Gender Attitudes
Attitudes in relation to gender and acceptability of violence (9 items) based on prior research in South Africa. Responses (Strongly Disagree to Strongly Agree) range 9-45, higher scores indicative of greater inequitable gender attitudes.
Measured: 6 months post baseline
Violence towards children
Among those reporting a child living in their home, perpetration of physical and/or emotional abuse in the past 4 weeks against the child, using 4 items. Recoded into yes/no.
Measured: 6 months post baseline
Trust in relationship/partner measured using the Dyadic Trust scale
8 Items forming the Dyadic Trust (Larzelere \& Huston, 1980), summed with range 8-45. Higher scores indicate more trust in relationship/partner.
Measured: 6 months post baseline
Relationship Satisfaction
5 items (Woolf-King et al., 2019) focused on satisfaction in relationship, with scores from 0-50, and higher scores indicate greater satisfaction in relationship.
Measured: 6 months post baseline
Fear of Emotional Intimacy
35 items, from (Descutner \& Thelen, 1991) responses Strongly Disagree to Strongly Agree (5 point Likert), range 35-175. Higher scores indicate greater fear of emotional intimacy.
Measured: 6 months post baseline
Empathy for Partner assessed with the Interpersonal Reactivity Index for Couples (IRIC) scale.
13 items, Empathetic concern using the Interpersonal Reactivity Index for Couples (IRIC) scale. (Péloquin \& Lafontaine, 2010) summed together to create score. Score range: 0-52, with higher scores indicating greater empathy for partner.
Measured: 6 months post baseline
Sexual Intimacy
13 items, drawn from Conroy et al. (2021), developed in Malawi, and previously used in South Africa. Responses: Strongly disagree to strongly agree (4 point Likert response). Individual items summed together to create a continuous score (13-52). Higher scores indicative of greater sexual intimacy
Measured: 6 months post baseline
Communication with partner assessed using the Communications Pattern Questionnaire
11 items, from the Communications Pattern Questionnaire and previously used in South Africa (Woolf-King et al., 2019). Range 11-55, higher scores indicate 'better' communication with partner.
Measured: 6 months post baseline
Depressive Symptoms assessed using the Patient Health Questionnaire - 9 (PHQ9)
Patient Health Questionnaire - 9 (PHQ9) asking about past 2 week symptoms of depression. Range 0-27. Higher scores indicative of more symptoms of depression.
Measured: 6 months post baseline
Anxiety Symptoms assessed using the Generalised Anxiety Disorder 7 (GAD7) questionnaire
Generalised Anxiety Disorder 7 (GAD7) (Spitzer et al., 2006) asking about past 2 weeks symptoms of anxiety. Range 0-21. Highers scores indicative of more symptoms of anxiety.
Measured: 6 months post baseline
Emotional Dysregulation assessed using the Difficulties in Emotional Regulation Scale 16
Difficulties in Emotional Regulation Scale 16 (DERS-16) - 16 items (Bjureberg et al., 2016) adapted for use in South Africa. Range 16-80, with higher scores indicating greater emotional dysregulation.
Measured: 6 months post baseline
Alcohol Consumption in past 3 months, assessed with modified Alcohol use disorders identification test consumption (AUDIT C)
Alcohol use disorders identification test consumption (AUDIT C) (3 items). Rather than asking about past 12 months as is normal, items reworded to ask about past 3 months (e.g. In the last 3 months, how often do you have a drink containing alcohol?). Response options as in original scale. Scores range from 0-13, with higher scores indicating more alcohol consumption.
Measured: 6 months post baseline
Earnings in past month
A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands (ZAR) and a continuous scale, with no upper limit.
Measured: 6 months post baseline
Money participant saved in past month
A single item question asks "In the last month how much did you put aside for savings?" Responses are in Rands (ZAR) and are on a continuous scale, with no upper limit.
Measured: 6 months post baseline
Hunger in the past month
Household food-security questionnaire (3 items) asking about hunger in the household in the past 4 weeks. Range 3-12 with higher scores indicative of greater food insecurity.
Measured: 6 months post baseline
Frequency of work efforts
7 items asking about work effort in the past 3 months, adapted for use in South Africa. Scored 0-3, with range 0-21, with higher scores indicative of greater livelihoods effort.
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 Jul 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, University College, London, Project Empower
- Responsible party
- Principal investigator, Andrew Gibbs, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975137
- Sponsor's protocol ID
- 1633030
- Other IDs
- MR/X004090/1
- Status last verified
- Jun 2026
- First submitted
- 7 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared at data repository 12 months after data collection is completed. Data will either be at the SAMRC data repository or the UK Data Service.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Evidenced-based Intervention to Reduce IPV for Use Among Young Heterosexual Couples in South Africa - Zithandani SSCF - Phase 2: Pilot
- ClinicalTrials.gov ID
- NCT06975137
- Acronym / sponsor ID
- 1633030
- Conditions
- Intimate Partner Violence (IPV), Earning Outcomes, Mental Health, Couple Communication, Couple Conflict, Couples
- Keywords
- informal settlements, South Africa, couples, intimate partner violence, couples communication, mental health, livelihoods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, University College, London, Project Empower
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is Zithandani SSCF feasible to deliver to young couples, and what are the barriers and opportunities in intervention delivery?
- Is Zithandani SSCF acceptable to participants? What do they like and what do they not like about the intervention?
- Is Zithandani SSCF safe for female participants and do they engage adequately?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zithandani Stepping Stones and Creating Futures | Experimental | Behavioral: Zithandani Stepping Stones and Creating FuturesCouples intervention delivered in groups of 4-7 heterosexual couples. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zithandani Stepping Stones and Creating FuturesDelivered 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. | Behavioural | Zithandani Stepping Stones and Creating Futures |
Primary outcome
Physical IPV
Time frame: 6 months post baseline
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)
Sexual IPV
Time frame: 6 months post baseline
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)
Emotional IPV
Time frame: 6 months post baseline
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)
Economic IPV
Time frame: 6 months post baseline
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)
16 secondary outcomes
Gender Attitudes
Time frame: 6 months post baseline
Violence towards children
Time frame: 6 months post baseline
Trust in relationship/partner measured using the Dyadic Trust scale
Time frame: 6 months post baseline
Relationship Satisfaction
Time frame: 6 months post baseline
Fear of Emotional Intimacy
Time frame: 6 months post baseline
Empathy for Partner assessed with the Interpersonal Reactivity Index for Couples (IRIC) scale.
Time frame: 6 months post baseline
Sexual Intimacy
Time frame: 6 months post baseline
Communication with partner assessed using the Communications Pattern Questionnaire
Time frame: 6 months post baseline
Depressive Symptoms assessed using the Patient Health Questionnaire - 9 (PHQ9)
Time frame: 6 months post baseline
Anxiety Symptoms assessed using the Generalised Anxiety Disorder 7 (GAD7) questionnaire
Time frame: 6 months post baseline
Emotional Dysregulation assessed using the Difficulties in Emotional Regulation Scale 16
Time frame: 6 months post baseline
Alcohol Consumption in past 3 months, assessed with modified Alcohol use disorders identification test consumption (AUDIT C)
Time frame: 6 months post baseline
Earnings in past month
Time frame: 6 months post baseline
Money participant saved in past month
Time frame: 6 months post baseline
Hunger in the past month
Time frame: 6 months post baseline
Frequency of work efforts
Time frame: 6 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be shared at data repository 12 months after data collection is completed. Data will either be at the SAMRC data repository or the UK Data Service.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zithandani Stepping Stones and Creating Futures in people with Intimate Partner Violence (IPV) and Earning Outcomes, run by University of Exeter at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical IPV (time frame: 6 months post baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.