CompletedNot Applicable

Culturally Adapted CMAP Plus LTP for Refugee Mothers with History of Self-harm in Pakistan

Pakistan80 participantsStarted 2022-04-01

Plain-language summary

Objectives: * To asses the feasibility and acceptability of a culturally adapted manual assisted brief psychological intervention (CMAP) plus Learning through Play (LTP) for refugee mothers with history of self-harm having children 0-33 months. (Integrated intervention called CMAP Plus) * To assess if CMAP Plus will reduce the repetition of self-harm in refugee mothers having children aged between 0-33 months. * To determine if the intervention improves infant development and maternal attachment. * To explore participants experiences with the intervention. Study design and setting: This will be a feasibility cluster randomized control trial (cRCT) of culturally adapted CMAP Plus LTP intervention with refugee mothers from Quetta and Peshawar, Pakistan. Sample size: We aim to recruit a sample of 80 refugee mothers in the study.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years and above refugee mothers with children aged between 0-33 months. * History of self-harm. * Resident in the study site. * Capacity to provide informed consent. * Available for the duration of the study. Exclusion Criteria: * Unable to provide consent due to severe mental or physical illness. * Unlikely to be available for the entire duration of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility measure

Timeframe: From baseline to 12th week (at the end of intervention)

Acceptability measure

Timeframe: From baseline to 12th week (at the end of intervention)

Trial details

NCT IDNCT05171192

SponsorPakistan Institute of Living and Learning

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Self-harm trials