Opportunities for Suicide Prevention Integration Into Task-shifted Mental Health Interventions in Low-resourced Contexts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS)
研究概览
简要总结
Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.
详细描述
The proposed research will (1) examine the epidemiology and health impacts of recurrent suicidal ideation on mothers over time, (2) characterize key features of suicidal ideation and finalize intervention package components within the study context, and (3) conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, we anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings. The focus of this registration is the pilot clinical trial.
A stratified cluster randomized controlled trial design, with 6 village clusters allocated in a 1:1 ratio to the intervention and control arms will be used. The stratification will be level of the Union Council (which is the smallest district administrative unit) and include Sihala and Shah Allah Ditta. While a village cluster (VC) will be the unit of randomization. Each VC will have 900-1400 population of women of reproductive age based within two to three contiguous catchment areas of the government employed community health workers called Lady Health Workers (LHWs). The reason for choosing village cluster as the unit of randomization is to minimize contamination/spillage between trial participants as the intervention will be delivered within community-based households. The intervention (KPZ) and control (EUC) village clusters will be geographically separated and the chance of intervention cluster participants regularly meeting control cluster participants will be negligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •for trial participants receiving the intervention:
- •Speak Urdu fluently
- •Be actively receiving care from a clinician
- •Have access to a mobile phone
- •Intending to reside in the study area for the entire duration of the follow up (approx. six months)
- •Has a child 3 years or under or is pregnant
排除标准
- •for trial participants receiving the intervention:
- •Women requiring immediate inpatient care for any reason (medical or psychiatric)
- •Women who do not speak and/or comprehend Urdu language
- •Inclusion Criteria for Peers and health system stakeholders:
- •Speak Urdu fluently
- •Be older than 18 at the time of recruitment
- •Have access to a mobile phone
- •Intending to reside in the study area for the entire duration of the follow up (approx. six months)
- •Exclusion Criteria for Peers and health system stakeholders:
- •Women with untreated suicidality
- •Women who do not speak and/or comprehend Urdu language
研究组 & 干预措施
KPZ Program (KPZ)
Participants in this group will receive the KPZ program in addition to EUC. This group will receive the culturally adapted suicide prevention package (KPZ) of services delivered by trained Peers. The KPZ package includes a culturally adapted approach to a co-designed safety plan. The assigned Peers will provide safety planning and Brief Contact Follow-Up. Contact follow up sessions will occur at the household level. A Peer will be assigned an eligible mother and visit her within no less than 48 hours of enrollment. The first session will be delivered within two days of detection, and follow up contacts conducted by a trained Peer at 24 hours, every two days (for one week), weekly (for 1 month), and monthly (for 5 months), totaling 13 KPZ sessions in all. Contact assesses how the participant is coping, if the safety plan is helpful, adjustments to the safety plan, assessment of the suicide ideation and depression, and providing basic motivational interviewing and referral as needed.
干预措施: KPZ Program (KPZ) (Behavioral)
KPZ Program (KPZ)
Participants in this group will receive the KPZ program in addition to EUC. This group will receive the culturally adapted suicide prevention package (KPZ) of services delivered by trained Peers. The KPZ package includes a culturally adapted approach to a co-designed safety plan. The assigned Peers will provide safety planning and Brief Contact Follow-Up. Contact follow up sessions will occur at the household level. A Peer will be assigned an eligible mother and visit her within no less than 48 hours of enrollment. The first session will be delivered within two days of detection, and follow up contacts conducted by a trained Peer at 24 hours, every two days (for one week), weekly (for 1 month), and monthly (for 5 months), totaling 13 KPZ sessions in all. Contact assesses how the participant is coping, if the safety plan is helpful, adjustments to the safety plan, assessment of the suicide ideation and depression, and providing basic motivational interviewing and referral as needed.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
Enhanced Usual Care (EUC)
Participants in this group will receive usual care enhanced by Lady Health Workers (LHWs) trained in WHO Mental Health Gap Action Programme (mhGAP) that will link at-risk women with the primary care facility based medical officer. The LHWs will follow the mhGAP protocol for imminent or low risk of suicide including ensuring the participant is safe, removing or reducing means, assigning a family member to ensure safety (if appropriate), providing psychoeducation, and referring and accompanying the individual to their primary care health center where a mhGAP trained doctor is staffed to resume care or make a referral to specialized care. Additionally, all women and healthcare workers are provided a 24 hour hotline number (hosted by a Pakistani based mental health organization called Taskeen) and are briefed on exactly what will happen if participant calls.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS)
时间窗: baseline, 3 months and 6 months
Suicidal behaviors and attempts measured with the CSSRS. The CSSRS asks about self-reported suicide attempt, aborted attempt, and interrupted attempt with "yes" or "no" questions. Any positive responses to these behaviors will be qualitatively coded as 'yes'. Behaviors are assessed at baseline as the past month and at 3 months and 6 months from the time of the previous assessment (e.g., past 3 months).
Percent eligible participants who consent
时间窗: 6 months
Percent eligible participants who agreed to participate
Percent of consented participants who started intervention
时间窗: 6 months
Percent consented participants who started intervention
Percent of participants who completed KPZ safety card
时间窗: 6 months
Percent of participants enrolled who completed KPZ safety card
Percent of participants who completed one brief contact follow up session
时间窗: 6 months
Percent of participants who completed one brief contact follow up session
Percent of participants who dropped out of KPZ intervention
时间窗: 3 months and 6 months
Percent of participants who dropped out of KPZ intervention
Percent participants who completed all follow up measures
时间窗: 6 months
Percent participants who completed all follow up measures
Percent missing measure items per participant
时间窗: 6 months
Percent of missing measure items per participant
Mean score Beck's Scale for Suicidal Ideation (BSI)
时间窗: baseline, 3 months and 6 months
Suicide ideation severity measured with BSI. BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during the past week. The first 19 items consist of three options graded are on a 3-point scale ranging from 0 to 2. These items are then summed to yield a total score, which ranges from 0 to 38. Higher scores indicate more higher severity of suicide ideation.
Median number of sessions completed
时间窗: 6 months
Median number of sessions completed by participants
次要结局
- Mean score Maternal Suicide Cognitions Scale(baseline, 3 months and 6 months)
- Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM).(6 months)
- Mean score Multidimensional Scale of Perceived Social Support (MSPSS)(baseline, 3 months and 6 months)
- Qualitative Interviews(6 months)
- Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention(6 months)
- Mean score Generalized Anxiety Disorder - 7 item (GAD-7)(baseline, 3 months and 6 months)
- Mean score Patient Health Questionnaire - 9 item (PHQ-9)(baseline, 3 months and 6 months)