Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention

NCT06350383 | Completed Results

• 2 other identifiers: AAAT8527K01TW011775
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Violence, Domestic; Psychological Distress

Keywords

Intimate partner violence (IPV); Randomized control trial (RCT); Wings of Hope (WINGS); Problem Management Plus (PM+); Kenya; Informal settlements (slums); Women

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Number of Participants Who Received Violence Services

  Baseline, 3-month follow-up, 6-month follow-up

• General Self-Efficacy Scale (GSE) Score

  Baseline, 3-month follow-up, 6-month follow-up

• Multidimensional Scale of Perceived Social Support (MSPSS) Score

  Baseline, 3-month follow-up, 6-month follow-up

• Safety Behavior Checklist

  Baseline, 3-month follow-up, 6-month follow-up

• General Anxiety Disorder Scale (GAD-7) Score

  Baseline, 3-month follow-up, 6-month follow-up

Other Outcomes (6)

• Quality Control/Intervention Fidelity

  Through study completion, an average of 6 months

• Facilitator Satisfaction and Ease of Intervention Delivery (EBPAS-36)

  Through study completion, an average of 6 months

• Number of Participants Who Experienced a Study-related Adverse Event

  Through study completion, an average of 6 months

Study Arms (2)

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.

Behavioral: WINGS+PM+

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.

Behavioral: PM+-only

Interventions

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.

WINGS+PM+

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.

PM+-Only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who self-identify as women are eligible to participate. Sex-at-birth will not be assessed.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reports experiencing IPV in the past 3 months using the WHO IPV-BSS screener
• Reports feeling safe participating in the study
• Able to provide informed consent and follow study procedures
• Fluent in English and/or Swahili
• At least 18 years of age

You may not qualify if:

• Does not report IPV in the past 3 months,
• Does not feel safe participating in study,
• Unable to provide informed consent and/or follow study procedures,
• Cannot communicate in English or Swahili,
• Under the age of 18 years

Sponsors & Collaborators

• Columbia University: lead
• Drexel University: collaborator
• Africa Mental Health Research and Training Foundation: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

Upendo Clinic

Nairobi, 00100, Kenya

Location

Kianda 42 Hospital

Nairobi, 0100, Kenya

Location

Results Point of Contact

• Title: Samantha C Winter, PhD
• Organization: Columbia University

scw2154@columbia.edu

212-851-2271

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel-group design

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 5, 2024
• Study Start: May 21, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 27, 2026
• Results First Posted: May 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)