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N/A N=260 Randomized Double-blind Supportive Care

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

Violence, Domestic · Psychological Distress

Enrolled (actual)
260
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Participants Who Experienced Psychological IPV — 62; 60; 42; 47 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
WINGS+PM+ (Behavioral); PM+-only (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Columbia University
Primary completion
Apr 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Experienced Psychological IPV
62; 60; 42; 47; 39; 43
SECONDARY
Number of Participants Who Received Violence Services
130; 28; 119; 120; 123; 120
SECONDARY
General Self-Efficacy Scale (GSE) Score
23.1; 22; 27.9; 26.5; 29; 28.1
SECONDARY
Multidimensional Scale of Perceived Social Support (MSPSS) Score
43.9; 42.6; 56.4; 52.2; 58.4; 56.7
SECONDARY
Safety Behavior Checklist
4.3; 4.2; 3.9; 3.2; 3.3; 3.3
SECONDARY
General Anxiety Disorder Scale (GAD-7) Score
11.6; 10.6; 8.4; 8.5; 5.8; 5.8
SECONDARY
Patient Health Questionnaire (PHQ-9) Score
13.8; 13.2; 10.5; 10.8; 7; 7.5
SECONDARY
WHODAS 2.0 Score
26.7; 26; 22.1; 21.9; 20; 19.7
SECONDARY
Short Form of the Posttraumatic Stress Disorder Checklist (PCL-5) Score
9.6; 8.8; 5.7; 6.2; 4.1; 4.2
SECONDARY
Personalized Outcomes (PSYCHLOPS Score)
13.6; 13.4; 12.4; 12.2; 11.7; 11

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06350383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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