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| ID | Type | Description | Link |
|---|---|---|---|
| K01TW011775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Drexel University | OTHER |
| Africa Mental Health Research and Training Foundation | UNKNOWN |
| Fogarty International Center of the National Institute of Health | NIH |
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The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic.
Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at Kianda 42 Clinic in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting patients will be screened for recent experiences of IPV (past 3 months) by nurses or staff using an adapted version of the World Health Organization (WHO) IPV Brief Self-screener (IPV-BSS) and asked several mental health and functioning questions.
Informational scripts about the study will be shared and posted at the two clinics and also shared by community health volunteers (CHVs) with clinic patients during routine household visits. Every CHV who is attached to a clinic is responsible for doing routine visits with clinic patients in up to 100 households each month in the informal settlement in which the clinic is located. The purpose of these routine household visits is to check-in on patients, let households know about new or relevant clinic programs, and carry out relevant health-related trainings (e.g., how to treat water during a cholera outbreak or how to practice proper hygiene during COVID). The informational script will let patients in the clinics and broader community know that, if they are interested in the program, they can come to the clinic to be screened for eligibility.
Eligibility/IPV screens will be collected by trained non-specialist in-take staff in a private in-take room at the Kianda 42 Clinic in Kibera and Upendo in Mathare. Screening is anonymous. No identifying information will be collected as part of the screen. Answers to the screening questions will be recorded on digitally on study tablets. Verbal consent for eligibility screens will be collected. In-take staff will note on the informed consent document that the participant verbally consented to the screening, and sign their own names to attest to participants' consent.
If women screen positive for IPV in the past three months and meet the rest of the eligibility criteria, they will be asked if they are interested in participating in the feasibility trial. If they express interest, they will be referred to a trained CHV who will take them through the a digital Informed Consent Process for the feasibility trial.
Consenting participants will be guided through a baseline assessment by a CHV and then randomized to either the combined WINGS+PM+ (n=130; 65 at Kianda 42 and 65 at Upendo) or the psychological-only (PM+) arm (n=130; 65 at Kianda 42 and 65 at Upendo). Block randomization with random block sizes will be used to "force" a balance between study arms with respect to the number of women per arm per clinic.
WINGS+PM+ and PM+-only sessions will be delivered by trained CHVs at Kianda 42 and Upendo. WINGS+PM+ is a safety, harm reduction, and brief psychological intervention combined and adapted by community members from informal settlements in Kenya (IPV survivors, health clinic staff, and CHVs) from two evidence-based interventions: Wings of Hope (WINGS) and Problem Management Plus (PM+). This intervention was designed to be facilitated by non-specialists (e.g., CHVs). It involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV (e.g., the role of household economics in IPV); building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention.
Intervention outcomes will be assessed at four time points: baseline, immediately post intervention (IPI), 3-month, and 6-month follow-up.
To reduce contamination, CHVs will either carry out assessment or facilitate the intervention. Some CHVs will deliver PM+-only while others will deliver the WINGS+PM+ intervention. Project staff will meet regularly with CHVs providing PM+ only to establish the types of support and counselling they offered to participants and check that there was no contamination of the WINGS+PM+ strategies in the PM+-only arm. All intervention sessions will be audio-recorded for quality assurance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WINGS+PM+ | Experimental | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV; building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
|
| PM+-Only | Active Comparator | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WINGS+PM+ | Behavioral | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention combined and adapted by community members from informal settlements in Kenya (IPV survivors, health clinic staff, and CHVs) from two evidence-based interventions: Wings of Hope (WINGS) and Problem Management Plus (PM+). This intervention was designed to be facilitated by non-specialists (e.g., CHVs). It involves seven 90-minute weekly sessions. The intervention is informed by social cognitive theory. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Psychological IPV | A modified version of the World Health Organization Violence Against Women (WHO VAW) Questionnaire will be used to measure recent experience of intimate partner violence (IPV). The WHO IPV diagnostic tool has been used in Kenya previously. It includes four items measuring psychological IPV (e.g., insulting, humiliating, scaring or intimidating participant, or threatening); six items measuring physical IPV (e.g., slapping, pushing, throwing something at, dragging, beating up, burning, or threatening or using a weapon against participant); and three items measuring sexual IPV (e.g., forcing intercourse or other sexual acts when participant does not want to engage or forcing participant to do something sexual that they find degrading or humiliating). Participants will be asked whether or not (0=no, 1=yes) and the number of times they experienced any of these IPV items in the prior 90 days at baseline and the 3- and 6- month follow-up. | Baseline, 3-month follow-up, 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Violence Services | Receipt of violence-related services will be measured with an item used in prior assessments of WINGS that asks, "Have you received any services, counselling or group support for partner abuse or violence from others in the past 90 days?" | Baseline, 3-month follow-up, 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Quality Control/Intervention Fidelity | Using monitoring systems from previous studies (adherence to activities and delivery quality checklists), investigators will assess intervention protocol fidelity. Investigators will audiotape all intervention sessions and randomly select and review 20% in order to assess quality control and implementation fidelity. Fidelity levels below 80% will trigger retraining and closer supervision. |
Inclusion Criteria:
Exclusion Criteria:
Women who self-identify as women are eligible to participate. Sex-at-birth will not be assessed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upendo Clinic | Nairobi | 00100 | Kenya | |||
| Kianda 42 Hospital |
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Randomization occurred at the participant level. No units other than participants were randomized.
260 women from two clinics were recruited from two public health clinics in Nairobi informal settlements between May and August 2024. The clinics were Upendo in Mathare and Kianda 42 in Kibera.
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| ID | Title | Description |
|---|---|---|
| FG000 | WINGS+PM+ | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV; building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
| FG001 | PM+ Only | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WINGS+PM+ | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV; building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Psychological IPV | A modified version of the World Health Organization Violence Against Women (WHO VAW) Questionnaire will be used to measure recent experience of intimate partner violence (IPV). The WHO IPV diagnostic tool has been used in Kenya previously. It includes four items measuring psychological IPV (e.g., insulting, humiliating, scaring or intimidating participant, or threatening); six items measuring physical IPV (e.g., slapping, pushing, throwing something at, dragging, beating up, burning, or threatening or using a weapon against participant); and three items measuring sexual IPV (e.g., forcing intercourse or other sexual acts when participant does not want to engage or forcing participant to do something sexual that they find degrading or humiliating). Participants will be asked whether or not (0=no, 1=yes) and the number of times they experienced any of these IPV items in the prior 90 days at baseline and the 3- and 6- month follow-up. | Participants from Kibera clinic only (n=130) were assessed for this outcome. | Posted | Count of Participants | Participants | Baseline, 3-month follow-up, 6-month follow-up |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WINGS+PM+ | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV; building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha C Winter, PhD | Columbia University | 212-851-2271 | scw2154@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2024 | Apr 30, 2026 | Prot_SAP_000.pdf |
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Two-arm, parallel-group design
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Participants will not be told to which arm they have been randomized. Additionally, to reduce contamination, community health volunteers (CHVs) will either carry out assessment or intervention, not both. Assessors will not be told to which arm participants they are assessing have been assigned.
|
| PM+-only | Behavioral | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions. |
|
| General Self-Efficacy Scale (GSE) Score |
IPV self-efficacy will be assessed using a modified version of the general self-efficacy scale (GSE). The total score range is 10 to 40; higher scores indicate greater self-efficacy. |
| Baseline, 3-month follow-up, 6-month follow-up |
| Multidimensional Scale of Perceived Social Support (MSPSS) Score | Social Support will be measured with the 12-item MSPSS, which assesses the availability of emotional and instrumental support and advice for relationship conflict or problems with intimate partners and other issues. Items are measured on a 7-point Likert scale ranging from very strongly disagree (1) to very strongly agree. The total score range is 12 to 84; higher scores indicate greater perceived social support. | Baseline, 3-month follow-up, 6-month follow-up |
| Safety Behavior Checklist | Safety behaviors will be assessed using an updated version of a 7-item safety behavior checklist to determine present use of safety behaviors and to chart future adoption. The adjusted total score falls within a 0-7 range of behaviors performed, with higher scores suggesting more safety behaviors. | Baseline, 3-month follow-up, 6-month follow-up |
| General Anxiety Disorder Scale (GAD-7) Score | The GAD-7 is a 7-item self-reported questionnaire used to measure anxiety severity, with total scores ranging from 0 to 21. A higher score indicates more severe anxiety. | Baseline, 3-month follow-up, 6-month follow-up |
| Patient Health Questionnaire (PHQ-9) Score | Depression was assessed using the patient health questionnaire. The total score ranges from 0 to 27, with a higher score indicating greater severity of depression. | Baseline, 3-month follow-up, 6-month follow-up |
| WHODAS 2.0 Score | Functional impairment will be measured using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0. This 12-item instrument assesses difficulty in completing activities in the last 30 days (total score range is 0-48; higher scores indicate greater impairment severity). The WHODAS 2.0 has been used widely as a screening and outcome measure, demonstrates moderate to strong evidence of construct- and criterion-related validity, displays good sensitivity to change and has been used previously in PM+ efficacy trials in Kenya and in informal settlements in Kenya. | Baseline, 3-month follow-up, 6-month follow-up |
| Short Form of the Posttraumatic Stress Disorder Checklist (PCL-5) Score | A four-item, short version of the Posttraumatic Stress Disorder Checklist (PCL) will be used to measure symptoms of PTSD. The PCL was adapted and used for an efficacy trial of PM+ in Kenya. Items are scored with a 5-point Likert ranging from 0= "not at all" to 4="extremely". The total score ranges from 0 to 16, with higher scores suggesting symptoms of PTSD. | Baseline, 3-month follow-up, 6-month follow-up |
| Personalized Outcomes (PSYCHLOPS Score) | The Psychological Outcome Profiles (PSYCHLOPS) scale will be used to assess change in relation to problems that are identified by the participant. It asks respondents to nominate 2 of their main problems and to provide ratings on the magnitude of the problems and their effects on functioning and well-being in the previous week. It is sensitive to change and is internally reliable. PSYCHLOPS assesses the impact of interventions on problems that are not necessarily assessed by other standardized measures; thus, it can be useful in the context of informal settlements, where people can suffer a diverse range of problems. The total score range is 0 to 20, with a higher score indicating greater problem severity. | Baseline, 3-month follow-up, 6-month follow-up |
| Through study completion, an average of 6 months |
| Facilitator Satisfaction and Ease of Intervention Delivery (EBPAS-36) | Facilitator satisfaction and ease of intervention delivery will be assessed with a shortened version of the Evidence-Based Practice Attitude Scale (EBPAS-36). Responses are given on a 5-point Likert scale ranging from 0="not at all" to 4="to a very great extent." With high scores indicating satisfaction. | Through study completion, an average of 6 months |
| Number of Participants Who Experienced a Study-related Adverse Event | Safety will be assessed through adverse event reporting by CHVs/Research Assistant (RA)/clinic staff and exit interviews with CHVs asking about negative intervention experiences. | Through study completion, an average of 6 months |
| Participant Satisfaction With Intervention | Participants will be asked to rate their satisfaction with the session at the end of each intervention session. Participant satisfaction was assessed using a four-point Likert scale ranging from not at all satisfied (1) to very satisfied (4). The number of participants who scored 3 or above (representing satisfied or very satisfied) is reported. | At study completion, about 6 months post-intervention |
| Attendance Rate | Attendance rate will be reported as the percent of participants who completed all sessions of the study intervention. | Through study completion, an average of 6 months |
| Retention Rate | Number of participants who completed the 3-month assessment and the 6 month-assessment after receiving the study intervention. | 3-month follow-up and 6-month follow-up |
| Nairobi |
| 0100 |
| Kenya |
| BG001 | PM+ Only | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | WINGS+PM+ | WINGS+PM+ is a safety, harm reduction, and brief psychological intervention that involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV; building motivation to address IPV; safety planning and revision; enhancing social support to address IPV; goal setting and revision; identifying IPV-related services and needs; linkage and referral to services; self-care planning; learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
| OG001 | PM+ Only | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. |
|
|
| Secondary | Number of Participants Who Received Violence Services | Receipt of violence-related services will be measured with an item used in prior assessments of WINGS that asks, "Have you received any services, counselling or group support for partner abuse or violence from others in the past 90 days?" | Posted | Count of Participants | Participants | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | General Self-Efficacy Scale (GSE) Score | IPV self-efficacy will be assessed using a modified version of the general self-efficacy scale (GSE). The total score range is 10 to 40; higher scores indicate greater self-efficacy. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | Multidimensional Scale of Perceived Social Support (MSPSS) Score | Social Support will be measured with the 12-item MSPSS, which assesses the availability of emotional and instrumental support and advice for relationship conflict or problems with intimate partners and other issues. Items are measured on a 7-point Likert scale ranging from very strongly disagree (1) to very strongly agree. The total score range is 12 to 84; higher scores indicate greater perceived social support. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | Safety Behavior Checklist | Safety behaviors will be assessed using an updated version of a 7-item safety behavior checklist to determine present use of safety behaviors and to chart future adoption. The adjusted total score falls within a 0-7 range of behaviors performed, with higher scores suggesting more safety behaviors. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | General Anxiety Disorder Scale (GAD-7) Score | The GAD-7 is a 7-item self-reported questionnaire used to measure anxiety severity, with total scores ranging from 0 to 21. A higher score indicates more severe anxiety. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) Score | Depression was assessed using the patient health questionnaire. The total score ranges from 0 to 27, with a higher score indicating greater severity of depression. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | WHODAS 2.0 Score | Functional impairment will be measured using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0. This 12-item instrument assesses difficulty in completing activities in the last 30 days (total score range is 0-48; higher scores indicate greater impairment severity). The WHODAS 2.0 has been used widely as a screening and outcome measure, demonstrates moderate to strong evidence of construct- and criterion-related validity, displays good sensitivity to change and has been used previously in PM+ efficacy trials in Kenya and in informal settlements in Kenya. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | Short Form of the Posttraumatic Stress Disorder Checklist (PCL-5) Score | A four-item, short version of the Posttraumatic Stress Disorder Checklist (PCL) will be used to measure symptoms of PTSD. The PCL was adapted and used for an efficacy trial of PM+ in Kenya. Items are scored with a 5-point Likert ranging from 0= "not at all" to 4="extremely". The total score ranges from 0 to 16, with higher scores suggesting symptoms of PTSD. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
|
| Secondary | Personalized Outcomes (PSYCHLOPS Score) | The Psychological Outcome Profiles (PSYCHLOPS) scale will be used to assess change in relation to problems that are identified by the participant. It asks respondents to nominate 2 of their main problems and to provide ratings on the magnitude of the problems and their effects on functioning and well-being in the previous week. It is sensitive to change and is internally reliable. PSYCHLOPS assesses the impact of interventions on problems that are not necessarily assessed by other standardized measures; thus, it can be useful in the context of informal settlements, where people can suffer a diverse range of problems. The total score range is 0 to 20, with a higher score indicating greater problem severity. | Some participants in both study arms did not follow-up for assessment at 3 months and 6 months, so data could not be collected from those participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month follow-up, 6-month follow-up |
|
|
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| Other Pre-specified | Quality Control/Intervention Fidelity | Using monitoring systems from previous studies (adherence to activities and delivery quality checklists), investigators will assess intervention protocol fidelity. Investigators will audiotape all intervention sessions and randomly select and review 20% in order to assess quality control and implementation fidelity. Fidelity levels below 80% will trigger retraining and closer supervision. | Not Posted | Aug 2026 | Through study completion, an average of 6 months | Participants |
| Other Pre-specified | Facilitator Satisfaction and Ease of Intervention Delivery (EBPAS-36) | Facilitator satisfaction and ease of intervention delivery will be assessed with a shortened version of the Evidence-Based Practice Attitude Scale (EBPAS-36). Responses are given on a 5-point Likert scale ranging from 0="not at all" to 4="to a very great extent." With high scores indicating satisfaction. | Not Posted | Aug 2026 | Through study completion, an average of 6 months | Participants |
| Other Pre-specified | Number of Participants Who Experienced a Study-related Adverse Event | Safety will be assessed through adverse event reporting by CHVs/Research Assistant (RA)/clinic staff and exit interviews with CHVs asking about negative intervention experiences. | Posted | Count of Participants | Participants | Through study completion, an average of 6 months |
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| Other Pre-specified | Participant Satisfaction With Intervention | Participants will be asked to rate their satisfaction with the session at the end of each intervention session. Participant satisfaction was assessed using a four-point Likert scale ranging from not at all satisfied (1) to very satisfied (4). The number of participants who scored 3 or above (representing satisfied or very satisfied) is reported. | Posted | Count of Participants | Participants | At study completion, about 6 months post-intervention |
|
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| Other Pre-specified | Attendance Rate | Attendance rate will be reported as the percent of participants who completed all sessions of the study intervention. | Posted | Number | percent of participants | Through study completion, an average of 6 months |
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| Other Pre-specified | Retention Rate | Number of participants who completed the 3-month assessment and the 6 month-assessment after receiving the study intervention. | Posted | Count of Participants | Participants | 3-month follow-up and 6-month follow-up |
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|
| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | PM+ Only | PM+: is a brief psychological intervention also designed to be facilitated by non-specialists (e.g. CHVs) and focused on problem management and evidence-based behavioral strategies to enhance one's capacity to adaptively manage psychological distress. It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi, Kenya. PM+ involves five 90-minute, weekly individual sessions focused on learning and practicing a stress management technique; identifying, defining, and managing problems through goal setting and review; increasing engagement in positive activities; strengthening social supports; and developing plans to stay healthy and well beyond the intervention. | 0 | 130 | 0 | 130 | 0 | 130 |
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