Discussion
trauma, traumatic
ADVERSE EVENTS, EVENTS, BROWN
The overall aim of this randomized feasibility study of EASE in Lebanon was to inform adaptations needed to intervention and research protocols for a fully-powered RCT to assess effectiveness. We noted challenges with outreach and saw significant attrition between registration of interest and screening time-points, and between screening and baseline for those eligible. There were challenges among the EASE participants in terms of regular attendance at sessions, with only 63% of adolescents completing five or more EASE sessions; common reasons cited were school and work commitments, or transport issues. Nonetheless we found good retention rates among adolescents and caregivers in completing endline and follow-up assessments. Randomisation and blinding procedures were effective and feasible, and we noted minimal contamination. Fidelity and competency of EASE implementation was satisfactory, though time management and behaviour management were issues in some sessions. Outcome measures showed good psychometric properties on total scale scores, with low item-level missing data for most questionnaires. Our screening measure resulted in a positive screening rate of 49%, while baseline levels of distress on outcome measures were relatively low. We did not identify substantial patterns of change overtime on our outcome measures, (between or within groups) despite qualitative reports of positive impacts of EASE. We responded to a high number of adverse events throughout the study, necessitating referrals to other services, though none were deemed to be caused by or linked to participation in the study.Findings of this feasibility trial resulted in several improvements to study procedures to inform a forthcoming larger definitive trial [RCT procedures were adapted to overcome transportation challenges: (i) group sessions were held as close as possible to homes; (ii) caregivers were provided with the choice between provision of transportation via bus, or reimbursement of travel costs; (iii) outreach teams improved communication with caregivers before and during adolescent transportation; (iv) improvements were made to the contamination tool and assessor training in order to improve reliability of this measurement. We added an explicit check at screening that both adolescents and caregivers were willing to commit to attend to all EASE sessions should they be allocated to that condition. Recommendations were made to enable flexible scheduling of sessions to include evenings and weekends, and have facilitators remain in contact with caregivers over WhatsApp. Given the intense outreach efforts required to reach our pilot sample, we employed additional outreach staff for the RCT, and provided substantive training on methods for explaining the intervention, responding to concerns, and generating interest. To respond to the high rates of child protection and acute mental health needs experienced in the feasibility study, we hired additional staff members to support on these aspects during the full trial to ensure safety and adequate referral and follow up. The suitability of these adjustments will be monitored in the full trial.While most outcome measures were deemed understandable and appropriate, we adjusted the wording of some items that were found to be challenging and removed non-endorsed traumatic events from the trauma inventory. Notably, the CPDS screening tool lead to a sample with relatively low levels of distress overall on outcome measures, despite a prior validation study (Brown F, Steen F, Taha K, Koppenol-Gonzalez GV, Aoun M, Bryant RA, et al: Validation of Arabic versions of the Child Psychosocial Distress Screener and Pediatric Symptom Checklist for young adolescents living in vulnerable communities in Lebanon, Under review). One possibility for the lack of change over time in our study is a floor effect, possibly due to the fact that the CPDS assesses presence of psychosocial risk factors, rather than psychological distress. Based on this, we changed our screening tool for the RCT to the PSC-17 tool. While the increased length adds challenges for population-level screening, it has shown good internal consistency, test–retest reliability, and concurrent validity against a gold-standard psychiatrist assessment in Lebanon (Brown F, Steen F, Taha K, Koppenol-Gonzalez GV, Aoun M, Bryant RA, et al: Validation of Arabic versions of the Child Psychosocial Distress Screener and Pediatric Symptom Checklist for young adolescents living in vulnerable communities in Lebanon, Under review). Given the poor psychometric properties of PSC and CRIES subscales in this sample, our primary hypotheses for the full trial will focus on total scale scores.We expect that these amendments will lead to improved implementation of the EASE intervention and trial procedures for the RCT. A simultaneous feasibility trial of EASE in Jordan found similar lack of movement on outcomes, and similar possible floor effects [Although we have made significant adjustments to our implementation plan for the RCT to promote smooth implementation, these adjustments predominantly involve mobilising additional resources in terms of outreach staff and activities, support for following up with significant child protection and mental health needs, and enhanced transport options to sessions. While these resources may be needed in order to ensure adequate and comprehensive care is available for those who need it, it is important to note for future implementation of such interventions in protracted crises that these interventions are unlikely to be viable as standalone programmes, and must be integrated within existing services and support structures in order for them to be sustainable and effective. EASE may be optimally positioned within a multi-level and multi-sectoral care system whereby adolescents may be engaged in community level psychosocial support activities and educational activities, through which identification and referral to EASE can be made, and through which direct referrals can be available to more intensive case management for protection concerns, or specialised services for more severe mental health concerns, as required [While the group format of EASE has advantages in terms of increasing numbers of adolescents reached, and promoting social support, the scheduling of group session times and coordinating common locations reachable by adolescents across a fairly broad geographical area presented significant challenges for attendance, and necessitated significant transport costs. Future research should compare the effectiveness, overall cost-effectiveness, and sustainability of individual versus group treatment models of EASE.