Feasibility, Acceptability, and Preliminary Effect of Combined SRH-Mental Health Education and Cash Transfer on Reproductive and Mental Health Outcomes of Displaced Women in Ethiopia. A Pilot Study.

Interventions
This study has two intervention arms (T1 &T2) and one control (T0). T1 will receive integrated sexual and reproductive health (SRH) and mental health (MH) education. T2 will receive the same integrated SRH-mental health education along with a conditional cash transfer. T0 will serve as the control group and receive standard of care. The SRH-MH education will include relevant topics from both SRH and MH. Key topics on SRH education include, but are not limited to, family planning, types of modern contraceptive methods, where to access them, how to use them, potential side effects and how to manage them, barriers to modern contraception (individual, societal, and community-related), stigma and discrimination, misconceptions about contraceptives, myths, and partner communication. Additionally, gender-based violence prevention and how to seek care will be covered.
The MH component of the education will be adopted from Problem Management Plus (PM+), a low-intensity psychological intervention developed by the World Health Organization (WHO). PM+ is specifically designed to address common mental health conditions in communities facing adversity. It will mainly focus on four core strategies that improve mental health and psychosocial well-being. The first strategy is stress management, where participants are taught relaxation techniques aimed at regulating anxiety and emotional distress. The second strategy, problem management, involves guiding participants to systematically identify and address practical problems that are solvable, empowering them to take proactive steps toward managing challenges in their daily lives. The third strategy, behavioral activation, encourages participants to re-engage with positive and task-oriented activities that promote improved mood and overall functionality. The fourth, strengthening social support, focuses on helping participants build or enhance connections with trusted individuals or community networks, thereby reducing isolation and fostering a sense of belonging. Additionally, the mental health component includes healthy parenting practices and psychoeducation on common reactions to adversity, helping participants understand typical emotional responses to stressful situations and providing guidance on how to prevent relapse to maintain progress over time.
Intervention Arms
Arm 1(T1): SRH-MH Education:
Participants in this arm will receive a group-based education intervention focusing on SRH and mental health topics, as outlined in the intervention components. The intervention will have 6 sessions. Each session will last three hours and will be delivered by trained Community health workers. The group-based education with a group size of 15 women will be conducted in a separate and secure room found within the camps. The sessions will occur every fifteen days over 3 months, ensuring consistent engagement and knowledge reinforcement to see the preliminary effects of the intervention.
Arm2 (T2). SRH-MH Education + Cash Transfer Arm:
In addition to the education service, participants in this group will receive an unconditional 500 Ethiopian Birr per month for three months as a transportation allowance to seek care from the public health facility or to socialize with people in the host community. It also aims to alleviate financial stress and enhance recipients' sense of control and self-efficacy, which are critical for improving both psychosocial and reproductive health outcomes. In terms of mental health, evidence suggests that even small cash transfers can alleviate financial stressors, indirectly reducing symptoms of anxiety and depression by improving recipients’ sense of control and self-efficacy(Maara et al., 2023).
Arm 3 (T0): Standard Care (control arm)
Participants in the control arm will receive only the existing standard of care provided within the displacement camps. Standard of care refers to the routine health services that displaced women and their children typically receive within the camp setting, without any additional SRH-MH education sessions or cash transfers provided by the study. This includes services delivered by governmental and humanitarian organizations, such as basic primary healthcare and maternal and child health consultations. The standard of care serves as a baseline level of support that is consistently available across all study arms.

2026-01-15

2026-04-15

Primary outcomes of the study include a change in the depression symptoms score and a change in the contraceptive uptake rate

Depression Score (PHQ-9)
Change in depression score will be assessed using the Patient Health Questionnaire (PHQ-9), a depression symptom screening tool that consists of nine items, each score of 0-3, and it is validated in Ethiopia (Bekeko et al., 2025b; Woldetensay et al., 2018).
Contraceptive uptake rate is defined as the percentage of women of reproductive age who are currently using any contraceptive method within the last month before the survey. Baseline and endline surveys will assess contraceptive use via self-reporting “yes” or “no” questions, adopted from the Ethiopian Demographic and Health Survey (EDHS) survey tool. Participants will be asked: “Are you or your partner currently using any method to delay or avoid pregnancy?” Follow-up questions will identify the specific method(s) used.

Change in contraceptive knowledge level, change in anxiety symptom scores, change in social support score, and change in Parenting Stress scores.
Acceptability and feasibility of the study will also be assessed as secondary outcomes: Acceptability will be assessed using the AIM 4-item scale (5-point Likert; mean score ≥4.0 indicates acceptable), and the feasibility of the study will be measured using quantitative feasibility indicators: Recruitment rate: ≥70% of eligible women enrolled, Retention rate: ≥80% complete all sessions, Attendance/adherence: ≥75% attend ≥80% of sessions, and Intervention fidelity: ≥80% of core components delivered as planned (checked via session checklists)

The pilot study will employ a three-arm clustered randomized controlled trial (cRCT) design with two treatment arms (T1 and T2) and one control group (T0). 15 administrative units (serving as clusters in our study) will be randomly selected from a total of 75 administrative units across three displacement camps. From each selected cluster, 15 eligible participants will be randomly recruited. The 15 clusters will then be randomly and equally assigned to the treatment and control groups.
study participates and eligibility criteria: Inclusion criteria: Internally displaced reproductive-age women residing in the Bakelo, China, or Woyinishet camps in the North Shewa Zone of Central Ethiopia, who have at least one child aged 6 to 59 months, will be randomly selected and included in the study. Eligible participants must provide informed oral consent and express their willingness to participate in the study.
Exclusion criteria: Women with severe mental health conditions requiring immediate clinical intervention, such as psychosis or active suicidal ideation, will be excluded. This exclusion is necessary to ensure participant safety and ethical integrity, as these conditions require specialized care beyond the scope of the study. The inclusion and exclusion criteria are designed to focus on reproductive-age women who can meaningfully engage with the intervention while maintaining methodological rigor.

Not available

The randomization will be conducted at the cluster level, with administrative blocks in the displacement camps serving as the unit of randomization. Across three camps, there are 75 administrative blocks (22 blocks in China Camp, 20 blocks in Woyinishet Camp, and 33 blocks in Bakelo Camp). From these 75 blocks, a random sample of 15 blocks (5 per camp to maintain geographical representation) will be selected using computer-generated random numbers in Stata software to ensure unbiased and reproducible selection. Following block selection, 15 individual participants will be randomly chosen from each selected block to participate in the study. Participant lists within each block will be compiled based on existing household numbers, and participants will be selected using randomly to ensure equal probability of inclusion and minimize selection bias. If more than one eligible woman is present in a household, one will be randomly selected using a simple random method (drawing lots)
The 15 selected blocks will then be randomized to one of three study arms: SRH-MH intervention, SRH-MH with cash transfer intervention, and control in a 1:1:1 allocation ratio. Random allocation will be performed using the uniform () function in Stata, with a fixed seed set for reproducibility. To ensure allocation concealment, the random sequence generation and assignment of blocks will be conducted by an independent statistician uninvolved in participant enrollment or intervention delivery. The allocation sequence will be securely stored and inaccessible to field staff until assignment. Enrolment of participants within blocks will be conducted by field staff blinded to the intervention assignment to minimize selection and performance biases. The assignment of blocks to specific interventions will be communicated to the field team only after participant recruitment is completed. This process will guarantee an unbiased and transparent allocation sequence while maintaining methodological rigor in participant selection and cluster randomization. Separation of roles between sequence generation, participant enrollment, and intervention assignment reduces the risk of bias and enhances the credibility of the trial findings.
Blinding and Allocation Concealment: While blinding of participants and deliverers is not feasible due to the nature of the cluster-randomized design and the interventions being tested, allocation concealment will be maintained during participant enrollment. Field staff enrolling participants within blocks will remain blinded to block-level randomization until after recruitment is complete.

The unit of randomization is the administrative blocks, which serve as clusters in our study.

Yes

This is a pilot trial study. A total of 15 clusters (administrative blocks in the displacement camp) will be the sample.

The planned number of observations are 225. This means 15 eligible participants from each cluster will be recruited.

Each study arm will include 5 administrative blocks with equal sample sizes across arms.

This is a pilot trial; thus, formal power calculation is not done.