Trial of the Youth Readiness Intervention (NCT01684488) | Clinical Trial Compass
CompletedNot Applicable
Trial of the Youth Readiness Intervention
Sierra Leone443 participantsStarted 2012-04
Plain-language summary
The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth.
In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone.
The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group.
In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.
Who can participate
Age range
15 Years – 24 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.
Once youth are referred to the study, a screening tool will be administered to determine whether or not they meet eligibility requirements as described below.
The screening tool contains four sections;
1. Consent and Age: assures that participants meet the age requirements
2. Oxford Refugees Psychosocial Adjustment Scale: assesses depression, anxiety and hostility
3. Functioning: assesses the participant's ability to carry out activities of daily living
4. Psychological Analysis: clinician's assessment of the psychological state of the participant.
Inclusion Criteria:
* Participants must be between 15-24 years of age;
* Participants must prefer to have the opportunity to join an educational program but not currently be enrolled in school;
* A participant's total score on the Oxford scale must equal or exceed 30 AND
* Participants must display at least one non-zero score on the functioning questions.
Exclusion Criteria:
* Participant does not plan to reside in the Freetown urban area for the duration of the study (9 months from start date);
* Participant fails to meet age requirements;
* Participant is currently enrolled in school;
* Participant is not in favor of joining an educational program;
* Participant fails to meet Oxford psychosocial or functioning thresholds;
* Participant is judged by clinical staff as:
* Needing mental health treatment beyond the scope of the YRI
* Otherwise not suitable for a group treatment setting
* Participant displays the following:…
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
1
Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0)
Timeframe: Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI