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临床试验/NCT06975137
NCT06975137已完成不适用

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

University of Exeter1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Physical IPV

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Zithandani Stepping Stones and Creating Futures

Experimental

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

干预措施: Zithandani Stepping Stones and Creating Futures (Behavioral)

结局指标

主要结局

Physical IPV

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

  • Gender Attitudes(6 months post baseline)
  • Violence towards children(6 months post baseline)
  • Depressive Symptoms assessed using the Patient Health Questionnaire - 9 (PHQ9)(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)
  • Empathy for Partner assessed with the Interpersonal Reactivity Index for Couples (IRIC) scale.(6 months post baseline)
  • Sexual Intimacy(6 months post baseline)
  • Communication with partner assessed using the Communications Pattern Questionnaire(6 months post baseline)
  • Anxiety Symptoms assessed using the Generalised Anxiety Disorder 7 (GAD7) questionnaire(6 months post baseline)
  • Emotional Dysregulation assessed using the Difficulties in Emotional Regulation Scale 16(6 months post baseline)
  • Alcohol Consumption in past 3 months, assessed with modified Alcohol use disorders identification test consumption (AUDIT C)(6 months post baseline)
  • Earnings in past month(6 months post baseline)
  • Money participant saved in past month(6 months post baseline)
  • Hunger in the past month(6 months post baseline)
  • Frequency of work efforts(6 months post baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Gibbs

Senior Lecturer

University of Exeter

研究点 (1)

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