Please select the eligibility criteria that correspond to the clinical trial below.
Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
Brief Summary: Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.

Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes.

Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.

Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization.

Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.

Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.


Options:
A: Inclusion Criteria:

* Resident of the village in which individual is studying (i.e., not a migrant scholar)
* Mature enough to understand the study and the consent process

Exclusion Criteria:

* N/A
B: Inclusion Criteria:

* Pregnant woman and their children
* Age 18 or older
* Informed consent

Exclusion Criteria:

* Psychosis, neurological damage, inability to communicate with interviewer
* Inability to give consent
C: Inclusion Criteria:

1. Age 18 or above;
2. Able to speak and understand the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
3. Asylum seeker or refugee;
4. Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
5. Both oral and written informed consent to enter the study.

Exclusion Criteria:

1. Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
2. Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
3. Clinical evidence of imminent suicide risk or suicide risk scored as "moderate or high" (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY);
4. Clinical evidence that the decision-making capacity is impaired.
D: Inclusion Criteria:

* Of Burmese origin
* Currently living in one of 20 target communities in Tak province, Thailand
* Primary caregiver to at least one child aged 8 to 12 years
* Child aged 8 to 12 years
* Participating in the family intervention

Exclusion Criteria:

* Children living in orphanages, boarding houses, factories or other institutions
* Persons with severe cognitive or physical disability who are impaired and unable to understand and give informed consent

Answer: C