Suicide Prevention Integration Into Task-shifted Mental Health Interventions

Browse trials for

• Suicide 701
• Suicide Prevention 190
• Suicidal Ideation 515

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 50 is below the median of 104 across 560 interventional studies indexed under Suicide.

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Eligibility criteria

Study arms

• Experimental
  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.

  Behavioral: KPZ Program (KPZ) · Behavioral: Enhanced Usual Care (EUC)

• Active comparator
  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.

  Behavioral: Enhanced Usual Care (EUC)

Interventions

• BehavioralKPZ Program (KPZ)

  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.

• BehavioralEnhanced Usual Care (EUC)

  Participants 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 outcomes

1. Mean score Beck's Scale for Suicidal Ideation (BSI)

   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.

   Time frame: baseline, 3 months and 6 months

2. Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS)

   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).

   Time frame: baseline, 3 months and 6 months

3. Percent eligible participants who consent

   Percent eligible participants who agreed to participate

   Time frame: 6 months

4. Percent of consented participants who started intervention

   Percent consented participants who started intervention

   Time frame: 6 months

5. Percent of participants who completed KPZ safety card

   Percent of participants enrolled who completed KPZ safety card

   Time frame: 6 months

6. Percent of participants who completed one brief contact follow up session

   Percent of participants who completed one brief contact follow up session

   Time frame: 6 months

7. Percent of participants who dropped out of KPZ intervention

   Percent of participants who dropped out of KPZ intervention

   Time frame: 3 months and 6 months

8. Median number of sessions completed

   Median number of sessions completed by participants

   Time frame: 6 months

9. Percent participants who completed all follow up measures

   Percent participants who completed all follow up measures

   Time frame: 6 months

10. Percent missing measure items per participant

    Percent of missing measure items per participant

    Time frame: 6 months

Secondary outcomes

1. Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM).

   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.

   Time frame: 6 months

2. Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention

   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.

   Time frame: 6 months

3. Mean score Patient Health Questionnaire - 9 item (PHQ-9)

   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.

   Time frame: baseline, 3 months and 6 months

4. Mean score Generalized Anxiety Disorder - 7 item (GAD-7)

   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.

   Time frame: baseline, 3 months and 6 months

5. Mean score Multidimensional Scale of Perceived Social Support (MSPSS)

   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.

   Time frame: baseline, 3 months and 6 months

6. Mean score Maternal Suicide Cognitions Scale

   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.

   Time frame: baseline, 3 months and 6 months

7. Qualitative Interviews

   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.

   Time frame: 6 months

Publications

• Tanveer J, Hamid E, Saeed G, Mumtaz S, Ahmad M, Rahman S, Noor-Ul-Huda, Malik SS, Rao N, Rahman A, Malik A, Sikander S, Hagaman A. Peer-delivered systems-integrated suicide prevention for women in Pakistan: a protocol for hybrid type II pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2026 Jun 13. doi: 10.1186/s40814-026-01841-7. Online ahead of print. PubMed 42286769 ↗

Individual participant data

Plan to share: Yes — What data that will be shared: Data associated with the trial will be deposited at ICPSR (Inter-university Consortium for Political and Social Research) which is an NIH-funded repository. Submitted data will conform with relevant data and terminology standards. The ICPSR website can be found here https://www.icpsr.umich.edu/web/pages/ Who will have access to the data: Data will be deposited and made available through ICPSR which is an NIH-funded repository, and that these data will be shared with investigators requesting data working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes such as meta analyses.

Supporting information: Study protocol