AIM
- RE-DEFINE will evaluate the effectiveness and cost-effectiveness of 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) (European trial).
- RE-DEFINE will evaluate the effectiveness and cost-effectiveness of Self Help Plus (SH+) in asylum seekers and refugees with psychological distress resettled in in Turkey, as compared with enhanced treatment as usual (ETAU) (Turkish trial).
ETHICS REQUIREMENTS
- RE-DEFINE Europe was approved by the Ethics Committees of Verona, Ulm, York, Turku, Liverpool, Vienna, and by the WHO Ethics Committee (D4.1).
- RE-DEFINE Turkey was approved by the Ethics Committee of Istanbul, and by the WHO Ethics Committee (D5.1).
- A group of experts giving advice on ethical issues related to the RE-DEFINE project was appointed as members of an Ethics Advisory Board (EAB).
- A Data Protection Officer (DPO) was appointed to supervise and regularly report that all data collection and processing is carried out according to EU and national legislations.
PROTOCOL REGISTRATION AND WEBSITE
- RE-DEFINE Europe was registered in clinicaltrial.gov (D4.1): https://clinicaltrials.gov/ct2/show/NCT03571347?term=redefine&rank=3
- RE-DEFINE Turkey was registered in clinicaltrial.gov (D5.1): https://clinicaltrials.gov/ct2/show/NCT03587896?term=redefine&rank=2
- A dedicated website regularly reports information, updates and new on the RE-DEFINE project and related activities: http://re-defineproject.eu/re-define-project/ (D7.2)
CULTURAL ADAPTATION OF SELF-HELP+ (D3.1, D3.2, D3.3, D3.4)
For the purposes of RE-DEFINE, Self Help Plus (SH+) was adapted for refugees and asylum seekers speaking Arabic, Urdu, Dari and Pidgin (Nigerian) English. The decision to focus on these languages was based on a situational analysis of migration flows, feasibility issues, and the needs of the RE-DEFINE sites. The SH+ package consists of: a pre-recorded audio recording; illustrated self-help book; facilitator manual; session guide (for use by facilitators when running SH+); training of trainers (TOT) program; facilitator training program. To develop these full versions of SH+, the following main tasks were completed: 1) revisions of the generic SH+ materials in English, based on feedback from previous use of SH+, and 2) an iterative process of translating, reviewing, and revising the Arabic, Urdu, Dari and Pidgin (Nigerian) English materials that comprise SH+. Following translation, each of the versions of the SH+ audio and self-help book were reviewed by experts and tested with focus groups using cognitive interviewing: a systematic procedure for evaluating the extent to which materials are understandable, relevant and acceptable for each community. These results were used to further revise the SH+ intervention materials. In addition, SH+ supporting materials (e.g. session guide, facilitator manual) were developed in the three languages, through an initial translation, review by experts and then subsequent revision. Also under this work package, training programs were developed for training SH+ trainers and SH+ facilitators. Overall, results from expert review and cognitive interviewing suggested that the versions of SH+ were acceptable, understandable and relevant for the target populations.
A training of trainers (ToT) has been completed in May 2018 in Verona. SH+ experts from WHO provided ToT to at least two representatives of European and Turkish sites involved in the randomized trials (D3.3).
COST-EFFECTIVENESS ANALYSIS (D6.1)
The University of Ulm, as leader of the WP6 (cost-effectiveness analysis), coordinated the development of a detailed cost-effectiveness analysis plan, reporting: information on the adaptation of the CCSRI-EU for use with asylum seekers and refugees in the RE-DEFINE project; a health economic evaluation plan.
CURRENT SITUATION
- On January 1, 2018, the RE-DEFINE project started
- On September 1, 2018, the recruitment phase of the project started
- RE-DEFINE Europe is currently recruiting study participants speaking Arabic, Urdu, Dari and Pidgin (Nigerian) English (D4.2)
- RE-DEFINE Turkey is currently recruiting Arabic speaking participants (D5.2)
DELIVERABLES COMPLETED SO FAR
- Report of migration flows (D2.1)
- Report of asylum seeker and refugee situational assessment (D2.2)
- Dissemination plan (D7.1)
- Website development (D7.2)
- Data management plan (D1.2)
- First study subject approvals package (Europe) (D4.1)
- First study subject approvals package (Turkey) (D5.1)
- SH+ translated and culturally adapted (D3.1)
- Communication plan (D7.6)
- SH+ training materials (D3.2)
- Report of training of trainers (D3.3)
- Report of whole adaptation (D3.4)
- Cost-effectiveness analysis plan (D6.1)
- Midterm recruitment report (Europe) (D4.2)
- Midterm recruitment report (Turkey) (D5.2)
