Suicide Prevention Integration Into Task-shifted Mental Health Interventions
- Conditions
- SuicideSuicidal IdeationSuicide Prevention
- Interventions
- Behavioral: KPZ Program (KPZ)Behavioral: Enhanced Usual Care (EUC)
- Registration Number
- NCT06208293
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KPZ Program (KPZ) 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. KPZ Program (KPZ) Enhanced Usual Care (EUC) 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. Enhanced Usual Care (EUC) 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.
- Primary Outcome Measures
Name Time Method Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS) 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 6 months Percent eligible participants who agreed to participate
Percent of consented participants who started intervention 6 months Percent consented participants who started intervention
Percent of participants who completed KPZ safety card 6 months Percent of participants enrolled who completed KPZ safety card
Percent of participants who completed one brief contact follow up session 6 months Percent of participants who completed one brief contact follow up session
Percent of participants who dropped out of KPZ intervention 3 months and 6 months Percent of participants who dropped out of KPZ intervention
Percent participants who completed all follow up measures 6 months Percent participants who completed all follow up measures
Percent missing measure items per participant 6 months Percent of missing measure items per participant
Mean score Beck's Scale for Suicidal Ideation (BSI) 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 6 months Median number of sessions completed by participants
- Secondary Outcome Measures
Name Time Method Mean score Maternal Suicide Cognitions Scale baseline, 3 months and 6 months Maternal Suicide Cognitions Scale (developed from formative interviews with 20 women with a history of suicidal behavior or clinical practice with suicidal women and 3 focus group discussions with Pakistani clinicians to identify inductively defined mechanisms of suicidality) includes presence of the following characteristics hypothesized to be on the pathway to suicidality including : loneliness, abandonment, helplessness, hopelessness, burdensomeness, anger, patience and other concepts rated on a 3-point likert scale. Item scores are summed. Scores range from 16 to 48 with higher scores indicated more risk cognitions.
Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM). 6 months All 3 scales are 4-items to assess core implementation outcomes of implementer perceptions of the KPZ intervention. FIM assesses if the intervention is feasible, possible, and easy, AIM assesses the implementation outcome of acceptability where respondents indicate their approval, find it appealing, express liking, and welcome the intervention strategy, providing valuable insights into the overall acceptability of the implemented approach. IAM measures appropriateness as an implementation outcome measuring if the intervention seems fitting, seems suitable, seems applicable, and seems like a good match. Responses for all scales use a 5-point ordinal likert scale, ranging from 1=completely disagree to 5=completely agree.
Mean score Multidimensional Scale of Perceived Social Support (MSPSS) baseline, 3 months and 6 months The MSPSS is a 12 item questionnaire intended to measure the extent to which an individual perceives social support from Significant Others, Family and Friends. Each item is scored from 1 = Very Strongly Disagree, to 7 = very strongly agree). Total Scale: Sum across all 12 items, then divide by 12. Total score range from 1 to 7. Higher scores indicate more perceived social support.
Qualitative Interviews 6 months Qualitative Interviews with trial participants, implementing agents (e.g., Peers and their supervisors), and health system stakeholders will elicit feasibility, acceptability, and perceived mechanisms of change. They will also inquire about adaptations (what, when, where, etc), familial, social and political factors that impacted KPZ implementation and engagement, and recommendations for changes for the future implementation.
Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention 6 months The KAC is a 30-item questionnaire developed from our formative co-design research that assesses implementing agent (e.g., Peer) implementation domains of confidence (11 items), attitudes (acceptability, appropriateness, perceived benefit) (13 items), and knowledge (6 items) in implementing the elements of KPZ with the mother directly and within her social milieu (e.g., family engagement). The questionnaire assesses implementer understanding of their roles, confidence in identifying mothers at risk for suicide, and attitudes toward discussing and addressing suicide. Items are responded to with a 4-item Likert scale with responses ranging from 'none of the time' to 'all of the time'. The scale will be summed per sub-domain with a range of 0-39 for attitudes, 0-33 for confidence, and 0-18 for knowledge. Higher scores indicate more confidence, more positive attitudes, and more knowledge of KPZ intervention components and suicide myths.
Mean score Generalized Anxiety Disorder - 7 item (GAD-7) baseline, 3 months and 6 months Anxiety measured with GAD-7, a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
Mean score Patient Health Questionnaire - 9 item (PHQ-9) baseline, 3 months and 6 months Depression measured with PHQ-9. PHQ-9 is a 9-item validated questionnaire. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The item scores are summed with total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Trial Locations
- Locations (1)
Islamabad Capital Territory
🇵🇰Islamabad, Pakistan