Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT02128568
Eligibility Criteria:
The control group of the YRI are the only eligible participants to complete the biomarkers .They were screened based on the eligibility requirements for the YRI, 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 internalizing and externalizing problems in war affected youth and was developed and validated for use in Sierra Leone
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 from the control group of the YRI study; the inclusion criteria described below.
* Participants must be between 15-24 years of age;
* Participants must be school-intending at time of enrollment (2012)
* 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 functional impairment 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 fails to meet Oxford psychosocial or functioning thresholds;
* Participant is judged by clinical staff as:
o Needing mental health treatment beyond the scope of the YRI
* Otherwise not suitable for a cheek swab data collection.
* Participant displays the following:
* Severe cognitive delays which preclude comprehension and ability to respond to items on the Youth Assessment Battery
* Active suicidality
* Psychosis
* Risk of harm to themselves or others
Participants at risk of harm to themselves or others will be referred to local mental health or social work treatment facilities as appropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
24 Years
Study:
NCT02128568
Study Brief:
Protocol Section:
NCT02128568