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Completed

NCT Number: NCT06975137

Zithandani Stepping Stones and Creating Futures - 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:

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.

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Key information

Conditions

Intimate Partner Violence (IPV) Behavior Couple Communication Couple Conflict Couples Earning Outcomes Livelihoods Mental Health Personal Satisfaction Psychological Well-Being

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South African Medical Research Council

Durban, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Gender Attitudes

    Time frame: 6 months post baseline

    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.

  2. Violence towards children

    Time frame: 6 months post baseline

    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.

  3. Trust in relationship/partner measured using the Dyadic Trust scale

    Time frame: 6 months post baseline

    8 Items forming the Dyadic Trust (Larzelere & Huston, 1980), summed with range 8-45. Higher scores indicate more trust in relationship/partner.

  4. Relationship Satisfaction

    Time frame: 6 months post baseline

    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.

  5. Fear of Emotional Intimacy

    Time frame: 6 months post baseline

    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.

  6. Empathy for Partner assessed with the Interpersonal Reactivity Index for Couples (IRIC) scale.

    Time frame: 6 months post baseline

    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.

  7. Sexual Intimacy

    Time frame: 6 months post baseline

    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

  8. Communication with partner assessed using the Communications Pattern Questionnaire

    Time frame: 6 months post baseline

    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.

  9. Depressive Symptoms assessed using the Patient Health Questionnaire - 9 (PHQ9)

    Time frame: 6 months post baseline

    Patient Health Questionnaire - 9 (PHQ9) asking about past 2 week symptoms of depression. Range 0-27. Higher scores indicative of more symptoms of depression.

  10. Anxiety Symptoms assessed using the Generalised Anxiety Disorder 7 (GAD7) questionnaire

    Time frame: 6 months post baseline

    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.

  11. Emotional Dysregulation assessed using the Difficulties in Emotional Regulation Scale 16

    Time frame: 6 months post baseline

    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.

  12. Alcohol Consumption in past 3 months, assessed with modified Alcohol use disorders identification test consumption (AUDIT C)

    Time frame: 6 months post baseline

    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.

  13. Earnings in past month

    Time frame: 6 months post baseline

    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.

  14. Money participant saved in past month

    Time frame: 6 months post baseline

    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.

  15. Hunger in the past month

    Time frame: 6 months post baseline

    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.

  16. Frequency of work efforts

    Time frame: 6 months post baseline

    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.

Other outcomes

  1. Individual Attendance at Intervention

    Time frame: From enrollment to end of intervention deliver at ~7 weeks

    Proportion of sessions attended by individuals who provide informed consent.

  2. Couples Attendance at Intervention

    Time frame: From enrollment to end of intervention deliver at ~7 weeks

    Proportion of sessions attended by couples who provide informed consent.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Medical Research Council, South Africa
  • Project Empower
  • University College, London

Registry information

Official study title

Adapting an Evidenced-based Intervention to Reduce IPV for Use Among Young Heterosexual Couples in South Africa - Zithandani SSCF - Phase 2: Pilot

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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