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临床试验/NCT07492368
NCT07492368进行中(未招募)不适用

Development and Testing of a Smartphone-Delivered Climate Adaptation and IPV-Related Stress Intervention for Residents of Informal Settlements in Kenya Using Ecological Momentary Approaches

Africa Institute of Mental and Brain Health (AFRIMEB)1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2026年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
272
试验地点
1
主要终点
Incidence and Severity of Intimate Partner Violence (VAR CORR-5)

研究概览

简要总结

This study is testing a smartphone-delivered program to help women living in informal settlements in Kenya manage intimate partner violence (IPV) and stress related to extreme weather events. Women in these communities often face high levels of violence from partners, challenges caused by climate-related events, and limited access to support services.

Participants will be randomly assigned to either a mobile intervention or a comparison condition. The mobile program provides short, tailored sessions that help women learn safety planning, coping skills, and strategies for adapting to climate-related stress. The program also offers tools to improve communication and strengthen social support.

The main goal of the study is to see whether this smartphone-based approach can reduce the frequency and severity of IPV over 12 months. The study will also examine changes in stress levels, self-confidence in handling problems, social support, and safety behaviors.

Results from this study may help create accessible, scalable support for women experiencing IPV and climate-related stress in similar settings.

详细描述

This study is a randomized controlled trial designed to test the effectiveness of a smartphone-delivered intervention that integrates climate adaptation strategies with an evidence-based approach to reducing intimate partner violence (IPV) and related stress among women living in informal settlements in Kenya.

Women living in informal settlements face high levels of poverty, climate-related stressors, and intimate partner violence. Climate-related shocks can increase household stress and economic strain, which may in turn increase the risk of IPV. Despite growing evidence linking climate stress and violence, there are few scalable, low-cost interventions that address both climate-related stress and IPV risk simultaneously.

The intervention builds on prior formative and pilot work conducted in the R21 phase of this project. It combines climate adaptation and problem-solving strategies with core elements of the Women Initiating New Goals of Safety (WINGS) intervention. The program is delivered via smartphone and uses brief, event-triggered sessions to provide support when participants report elevated stress or conflict risk. Participants receive tailored content focused on safety planning, coping skills, communication strategies, and climate-related adaptation planning.

In the R33 phase, 272 women who previously participated in the R21 phase and meet eligibility criteria will be enrolled and randomized to either the smartphone intervention or a comparison condition. Participants will be followed for 12 months.

The primary outcome is the incidence and severity of intimate partner violence over the 12-month follow-up period. Secondary outcomes include stress, self-efficacy, social support, safety behaviors, and related mental health indicators. Assessments will occur at baseline and at multiple follow-up time points, including 3, 6, and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years or older
  • Resident of Kibera or Mathare informal settlement in Nairobi, Kenya
  • Speaks Swahili or English
  • Participated in the parent study (1R21MH127356)
  • Reported at least one form of intimate partner violence (psychological, -physical, or sexual) in the past 12 months
  • Willing to provide informed consent
  • Willing to use a smartphone for daily assessments and intervention activities

排除标准

  • No past-year intimate partner violence reported in parent study
  • Did not participate in the parent study (1R21MH127356)
  • Under 18 years of age
  • Unable to provide informed consent
  • Does not speak Swahili or English
  • Not a resident of Kibera or Mathare informal settlements

研究组 & 干预措施

Event-triggered WINGS-based EMI

Experimental

Participants receive the single-session WINGS plus ongoing, event-triggered Ecological Momentary Intervention (EMI) following extreme weather events (EWE)(heatwaves, cold spells, heavy rainfall). EMIs include daily prompts with personalized safety plans, SOS contacts, and service lists for two weeks post-EWE.

干预措施: Event-Triggered WINGS-Based EMI (Behavioral)

Event-triggered WINGS-based EMI

Experimental

Participants receive the single-session WINGS plus ongoing, event-triggered Ecological Momentary Intervention (EMI) following extreme weather events (EWE)(heatwaves, cold spells, heavy rainfall). EMIs include daily prompts with personalized safety plans, SOS contacts, and service lists for two weeks post-EWE.

干预措施: Single-Session Mobile WINGS (Behavioral)

Single-session WINGS (mobile version)

Active Comparator

Participants receive a one-time, self-administered mobile version of the WINGS intervention, including safety planning, psychoeducation, goal setting, and service referrals.

干预措施: Single-Session Mobile WINGS (Behavioral)

结局指标

主要结局

Incidence and Severity of Intimate Partner Violence (VAR CORR-5)

时间窗: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods

Measured using the WHO IPV diagnostic (VAW CORR-5) instrument, which includes subscales for controlling behaviors and sexual, physical, and emotional IPV.

次要结局

  • Safety Behaviors (Safety Behavior Checklist)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • Receipt of IPV-Related Services (SRI)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods)
  • Social Support (ESSI)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • Perceived Stress (PSS)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • Current Safety(Daily during two-week EMA periods)
  • Depression Symptoms (PHQ-9)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • Anxiety Symptoms (GAD-7)(Baseline, immediately post-single session of WINGS, and at 3, 6, and 12 months)
  • Emotional Stress (Momentary)(Daily during two-week EMA periods)
  • Climate Related Comfort(Daily during two-week EMA periods)
  • Social and Environmental Context(Daily during two-week EMA periods)
  • Coping Strategies(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • Disability and Functioning (WHODAS)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months)
  • IPV Self-Efficacy (DVSE)(Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMI periods)

研究者

发起方
Africa Institute of Mental and Brain Health (AFRIMEB)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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