Building Resilience Against ViolencE (BRAVE) (NCT03488290) | Clinical Trial Compass
CompletedNot Applicable
Building Resilience Against ViolencE (BRAVE)
Pakistan300 participantsStarted 2018-04-20
Plain-language summary
The study has both quantitative and qualitative components.
The objective of the quantitative study is:
To evaluate the effectiveness of Learning Through Play (LTP) Plus culturally adapted Trauma Focused Cognitive Behavior Therapy (TF-CBT) for post-traumatic stress symptoms in parents.
The objective of the qualitative study is:
To find out facilitators and barriers from the perspective of the participants and other stakeholders (e.g., clinicians, GPs, people delivering the LTP plus TF CBT intervention etc)
Who can participate
Age range
16 Years
Sex
ALL
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:
Participants will be included in the study if they are:
Parents over the age of 16 years who are living with their children age 3-6 years. They meet the criteria for Post-Traumatic Stress Disorder (PTSD) and are able to give informed consent
Exclusion Criteria:
Participants will be excluded from the study if they have:
Any diagnosed physical or learning disability which prevents them from attending the LTP+ group intervention, or suffering from psychosis or those who are actively suicidal. This will be assessed by the research team at screening stage. Any disabilities or diagnosed mental illness. Any parent who is on current use of anti-depressant medication. And a prior self-reported mental illness, including depression.
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.