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临床试验/NCT07132905
NCT07132905进行中(未招募)不适用

Randomized Pilot Trial of Church-Based Problem-Solving Therapy for Adolescent Girls and Young Women With a History of Gender-Based Violence in Zambia

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月19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)
入组人数
180
试验地点
2
主要终点
Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14)

研究概览

简要总结

This randomized controlled trial evaluates Mpata Yathu ("Our Space"), a trauma-informed, church-based counseling intervention for adolescent girls and young women in Lusaka, Zambia who have experienced gender-based violence and are living with or at risk for HIV. The intervention is delivered by lay counselors who provide individual problem-solving therapy and referrals for mental health, HIV, and GBV-related services. Participants are assigned to receive counseling immediately or after a three-month waitlist period. The study examines mental health, HIV-related outcomes, and the feasibility, acceptability, and fidelity of delivering this community-based intervention.

详细描述

Adolescent girls and young women in Zambia experience intersecting risks related to gender-based violence (GBV), mental health concerns, and HIV. Exposure to physical, sexual, emotional, or controlling violence is associated with psychological distress and may also create barriers to HIV prevention, treatment engagement, medication adherence, and clinic attendance. Limited availability of specialized mental health providers creates a need for culturally relevant, community-delivered approaches that can expand access to psychological support.

Mpata Yathu is a culturally adapted, lay counselor-delivered problem-solving therapy intervention based on the Friendship Bench model originally developed in Zimbabwe. The intervention was adapted through community-partnered processes for adolescent girls and young women in Lusaka with experiences of GBV and HIV-related vulnerability. Adaptations include trauma-informed and survivor-centered counseling practices, training on responding to GBV-related concerns, participant choice of lay counselor when feasible, and structured referral pathways for mental health, HIV, and GBV services. The intervention does not replace clinical or emergency care; participants requiring services beyond the scope of lay counseling are referred to appropriate providers.

The study uses a hybrid type 1 implementation-effectiveness randomized controlled design. This design assesses preliminary intervention effects while also examining implementation in real-world community settings. Participants are randomly assigned in a 1:1 ratio, using permuted blocks stratified by HIV status, to the intervention or waitlist control conditions. Allocation is generated and concealed through REDCap after completion of baseline procedures. Because counseling participation is apparent to participants and lay counselors, masking is not possible for intervention delivery; however, follow-up outcome assessors remain unaware of study assignment when feasible.

Intervention participants are offered up to six individual problem-solving therapy sessions during the first three months after enrollment. Waitlist control participants receive available usual care during this period and are offered the same intervention after the 3-month assessment. Each counseling session lasts approximately 45-60 minutes. Although sessions are intended to occur weekly, participants may complete sessions within a three-month period to accommodate school, work, caregiving, mobility, illness, and other barriers to participation. Counseling is delivered in private spaces at participating churches in the Matero and Chawama areas of Lusaka.

Lay counselors receive training in problem-solving therapy, trauma-informed and survivor-centered care, research ethics, confidentiality, GBV response procedures, referral protocols, and recognition of concerns requiring escalation. Ongoing supervision and fidelity monitoring support consistent delivery of the intervention. Session completion, counselor adherence to intervention procedures, participant experiences, and contextual barriers and facilitators are documented throughout implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, participants and lay counselors delivering the intervention will not be blinded to study arm assignment. However, quantitative outcome assessors conducting follow-up assessments at 3 and 6 months will be blinded to participants' group assignment to reduce bias in data collection. These assessors will not participate in intervention delivery and will be trained to avoid accessing materials or communication that could reveal arm status. Unblinding will only occur in the event of an adverse event or safety concern requiring knowledge of the participant's group assignment for appropriate clinical referral or management.

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •To be eligible for enrollment in the RCT, participants must meet the following criteria:
  • •aged 15 to 24 years;
  • •Speak Nyanja, Bemba, and/or English fluently;
  • •Reside in the Matero or Chawama constituency area during the time of recruitment;
  • •Report lifetime exposure to GBV, as assessed by the following sections of the WHO Multi-country Study on Women's Health and Domestic Violence Against Women instrument:
  • •Section 7 (Physical Violence by Intimate Partner): Reports of being slapped, pushed, hit with a fist, kicked, dragged, choked, or threatened/attacked with a weapon by a husband or partner.
  • •Section 8 (Sexual Violence by Intimate Partner): Reports of being physically forced to have sex, having sex out of fear, or being forced to engage in degrading sexual acts by a husband or partner.
  • •Section 9 (Emotional Abuse by Intimate Partner): Reports of being insulted, belittled, intimidated, or threatened by a partner.
  • •Section 10 (Physical Violence by Non-Partner): Lifetime experiences of being beaten or physically mistreated by someone other than a partner since age
  • •Section 11 (Sexual Violence by Non-Partner): Forced sex or sexual acts since age 15 by a non-partner, and childhood sexual abuse before age
  • •Exhibit moderate depressive symptoms indicated by a score of 10-14 on the 9-item Patient Health Questionnaire (PHQ-9), or common mental disorder (CMD) symptoms (e.g., depression, anxiety) as indicated by a score of 9 or higher on the 14-item Shona Symptom Questionnaire (SSQ-14); and
  • •Be living with HIV or demonstrate HIV risk behaviors, as defined by validated items from the World AIDS Foundation survey,25 including unprotected sex, multiple sexual partners, coerced sex, or transactional sex.

排除标准

  • •Women will be excluded if they:
  • •Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening
  • •Report severe symptoms of depression (score > 14 on PHQ-9) or no to mild depression symptoms (PHQ-9 score <10), and/or severe anxiety symptoms using the Generalized Anxiety Disorder 7-item scale or GAD-7 (score >14 on GAD-7)
  • •Have intellectual or cognitive disabilities that limit their ability to complete the screening tools, interact with a lay counselor and/or provide informed consent; and/or
  • •Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study.
  • •Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).

研究组 & 干预措施

Immediate Mpata Yathu Intervention

Experimental

Participants randomized to this arm will receive the Mpata Yathu intervention immediately after enrollment. Mpata Yathu is a church-based, lay counselor-delivered adaptation of the Friendship Bench problem-solving therapy model. The intervention includes six weekly individual counseling sessions focused on structured problem-solving techniques and delivered in private spaces within local Catholic churches in Lusaka, Zambia. Counseling is provided by trained lay counselors who are pastors, teachers, peer navigators, and other trusted community members. Sessions are trauma-informed and survivor-centered, with integrated referrals for mental health, HIV, or GBV-related support services as needed. Follow-up assessments occur at 3 and 6 months.

干预措施: Mpata Yathu ("Our Space") (Behavioral)

Waitlist Control - Delayed Mpata Yathu Intervention

Experimental

Participants in this arm will receive usual care during the first three months after enrollment and will then receive the Mpata Yathu intervention between Months 3 and 6. Mpata Yathu is a church-based, lay counselor-delivered problem-solving therapy adapted from the Friendship Bench model. It consists of six weekly individual counseling sessions, delivered in church settings by trained lay counselors using a trauma-informed, survivor-centered approach. Sessions include structured problem-solving and optional referrals for HIV, GBV, or mental health services. Follow-up assessments are conducted at 3 months (pre-intervention) and again at 6 months (post-intervention).

干预措施: Mpata Yathu ("Our Space") (Behavioral)

结局指标

主要结局

Change in symptoms of common mental disorders (CMDs) as measured by the Shona Symptom Questionnaire (SSQ-14)

时间窗: Baseline and 3-month follow-up

The primary outcome is change in symptoms of common mental disorders (CMDs), measured using the Shona Symptom Questionnaire (SSQ-14), a 14-item screening tool used in Friendship Bench studies. Each item is scored as 0 or 1, with a total score range of 0-14. Higher scores reflect greater symptom severity. The primary analysis will compare mean SSQ-14 scores between the intervention and waitlist control arms at the 3-month follow-up, prior to the waitlist group receiving the intervention. SSQ-14 will also be measured at 6 months to assess within-group changes, but this is not part of the primary between-group analysis.

次要结局

  • Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, 3-month, and 6-month follow-up)
  • Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale(Baseline, 3-month, and 6-month follow-up)
  • Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS)(Baseline, 3-month, and 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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