|- candidate number||28230|
|- NTR Number||NTR6846|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-nov-2017|
|- Secondary IDs||R2HC 19873 ELRHA, London, UK|
|- Public Title||Implementation of Psychological First Aid in a humanitarian settingin Sierra Leone|
|- Scientific Title||Strengthening evidence for the scaling of Psychological First Aid in a humanitarian setting in Sierra Leone|
|- hypothesis||We will evaluate pre-to post-test differences (i.e. improvements) between PFA-trained health care providers and non-PFA trained health providers on the acquired skills and competences in the practice of Psychological First Aid (PFA). |
|- Healt Condition(s) or Problem(s) studied||Psychological First Aid |
|- Inclusion criteria||1. Adults; 2. Adequate oral and written command of the English or Krio language; 3. As part of their job they are exposed to individuals who experience adversities. |
|- Exclusion criteria||1. Having previously received PFA training or a training with overlapping content before|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2016|
|- planned closingdate||31-mrt-2018|
|- Target number of participants||0|
|- Interventions||Health care providers assigned to the PFA training condition will receive a one-day, face-to face PFA group training. The training will be provided by trained local research staff originated from Sierra Leone to avoid language barriers and cultural differences. Rogers (2010) stated that people adopt new information better through their trusted social network and peers. |
In the WHO PFA training based on Psychological first aid: Guide for field workers (2011), the following topics are covered:
Knowledge: What is PFA and what is not, What are normal reactions to crisis events, Place of PFA in overall response, People who likely need special attention, Primary needs after a crisis events, Adapting PFA to the local context.
Communication and Social skills exercises: What to say and what not to say, Prepare, Look, Listen and Link.
Discussing own experiences: Attention for how to take care of yourself and team members.
Practicing PFA with role-play during different scenarios
|- Primary outcome||The primary outcome will be knowledge about PFA principles, and competency in applying psychosocial support in line with the PFA principles to individuals who are exposure to adversities. |
This will be assessed by:
|- Secondary outcome|| Knowledge-tests: Questionnaire with open answers, multiple choice test with only one right answer|
Case-vignettes presenting an individual exposed to a crisis event or adversity, Ebola-related or perhaps not. After being presented the vignette the participant is given 2 to max. 4 alternative options for an appropriate reaction.
|- Timepoints||Three assessments will be scheduled: Pre-PFA training, 3 months post-PFA training and 6 months post-PFA training|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Marit Sijbrandij|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marit Sijbrandij|
|- Sponsor/Initiator ||War Trauma Foundation|
(Source(s) of Monetary or Material Support)
|- Brief summary||Psychological first Aid (PFA) provides a mechanism to address mental health and psychosocial support (MHPSS) needs of acutely distressed people at scale in major humanitarian emergencies. PFA is trained to non-professional helpers and has been frequently used in recent crises, such as the recent Ebola virus disease (EVD) outbreak in West Africa. PFA training consists of a set of recommendations to service providers how to providing non-intrusive practical care and support; to assess needs and concerns of people exposed to crises; to help to address basic needs; to listen to people, without pressuring them to talk; to comfort people and reduce distress; to connect people to information, services and social supports; and to protect people from further harm if possible. However, it is unclear to what extent PFA is an effective strategy in humanitarian crisis settings. A first stept in evaluating PFAs effectiveness is to evaluate whether PFA training actually improves knowledge about adequate ways of supporting people after an adverse event in service providers.|
This cluster randomised controlled trial (cRCT) evaluates the effects of PFA training vs. no PFA training among service providers in Sierra Leona on the retention of knowledge on PFA principles, and their confidence in administering PFA. PHUs (N=129) will be randomised across 1) PFA training; and 2. Wailt-list. A total number of 392 Service providers will be assessed at pre-PFA, midline and endline.
|- Main changes (audit trail)|
|- RECORD||17-nov-2017 - 12-dec-2017|