T1 assessments will be scheduled within 1 week of the final EASE session (i.e. approximately 8 weeks after T0), T2 assessments will be scheduled at 12 weeks following T1 (i.e. approximately 20 weeks after T0), and T3 assessments will be scheduled at 52 weeks following T1 (i.e. approximately 60 weeks after T0).
All instruments have been translated into simple, non-formal Arabic that can be understood by participants in the region (i.e. Syrians, Lebanese, Palestinians, and Jordanians) following recommended procedures for cross-cultural psychology [29]. Steps conducted in Lebanon involved forward translation to Arabic, back translation to English by an independent translator to English, workshops with English-speaking and bilingual team members to review the translations and ensure they retained the original English meaning, cognitive testing with the target population to assess comprehensibility, completeness, relevance, and acceptability, review workshops to adjust as needed, and pilot testing with target populations.
All instruments will be delivered via face-to-face individual interview by trained research assistants, using Kobo electronic data collection software on tablets. Prior to taking part in the study, assessors will receive training on the basics of psychosocial assessments, sensitive interviewing, research ethics, gaining informed consent, study procedures and study instruments, risks of bias in collecting quantitative data, managing participant distress, adverse events reporting procedures, and data management (with role-playing of required skills). Ongoing monitoring of assessors’ competency will be conducted through regular supervision by the research coordinator.
In Jordan, assessments will be conducted in the home. In Lebanon, assessments will either be conducted in the home or in a community centre. Transportation will be provided for participants travelling to the community centre or they will receive reimbursement for any costs incurred in transportation. In the case that participants do not attend a scheduled assessment, three attempts will be made to contact them to schedule a new appointment, via phone calls, home visits, or by contacting alternative contacts provided.
Primary outcome
The primary outcome is psychological distress as assessed by the PSC-35 youth report [26]. It lists 35 symptoms (including internalising, externalising, somatic, social, and academic difficulties), that are rated for their frequency of occurrence on a 3-point scale ranging from 0 (never) to 2 (often). The total PSC-35 score is obtained by summing the scores of individual items, and ranges from 0 to 70. In a validation exercise in Lebanon, the measure showed high internal consistency (σ = .80), convergent validity, test-retest reliability, and concurrent validity with psychiatric clinical assessments (Brown FL, Taha K, Steen F, Aoun M, el Chammay R, Bryant R, Jordans MJD: Validation of Arabic versions of the Child Psychosocial Distress Screener and Pediatric Symptom Checklist for youth living in vulnerable communities in Lebanon, forthcoming). Since the PSC-35 consists of the 17 items of the PSC-17 plus an additional 18 items, screening scores for children on the PSC-17 items will be used at baseline, and therefore only the additional 18 items administered. We will ensure that there is a maximum of 2 weeks between screening and baseline assessments.
Secondary outcomes
Adolescent-reported outcomes
Symptoms of depression will be measured using the adolescent version of the Patient Health Questionnaire (PHQ-A) [30, 31]. This 9-item checklist asks how often in the past week respondents have experienced symptoms indicative of depressive disorders and is rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated by summing responses on all items with a maximum score possible of 27, indicating the highest level of depression symptom severity.
Symptoms of traumatic stress will be measured using the Children’s Revised Impact of Event Scale (CRIES-13) [32]. This 13-item scale measures the psychological and behavioural impact of potentially traumatic events through three subscales exploring intrusion (4-items), avoidance (4-items) and arousal (5-items). The items are rated on a scale of 0 (not at all) to 5 (often) and are added to calculate a severity score, with a maximum possible of 65. Higher scores indicate higher levels of distress consistent with possible post-traumatic stress.
The Impairment of Daily Functioning Questionnaire was developed specifically for these studies, following the process recommended by Bolton [33]. In formative qualitative work in Lebanon, adolescents and caregivers provided input on important daily activities that a child functioning well would be doing. This information was collated into a list of items, and then workshops were held with children where they were asked to group the activities into broader categories and rate the importance of these categories. Nine items were selected based on level of importance and relevance. Adolescents are asked to rate how much impairment they have been experiencing in these activities.
Wellbeing will be measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) [34]. This measure comprises 14 statements about thoughts and feelings, with respondents asked to indicate which score best describes their experience over the past week on a scale from 1 (none of the time) to 5 (all of the time). Scores across items are summed to arrive at a total between 14 and 70, with higher total scores indicating greater positive mental wellbeing.
In Jordan only, perceived belonging and psychological engagement in school (psychological membership) will be measured using the Psychological Sense of School Membership (PSSM) scale [35]. This multidimensional measure examines membership in school settings, specifically by looking at caring relationships within the school environment, and acceptance and rejection. The scale is composed of 18 items scored on a Likert scale ranging from 1 (not at all true) to 5 (completely true). Final scores are calculated by summing all responses and then dividing by the total number of items to produce an average score ranging from 1 to 5. Higher scores indicate a greater sense of perceived belonging and engagement at school.
In Lebanon only, a child Strategy Use Questionnaire (SUQ) was developed specifically for the Lebanon trial, which consists of 7 items related to the use of coping strategies (identifying emotions, relaxation techniques, behavioural activation, problem solving). Each item is scored on a frequency scale ranging from 0 (never) to 4 (all of the time).
Caregiver-reported outcomes
The PSC-35 caregiver report assesses psychosocial impairment and potential emotional and behavioural problems in children [26]. The PSC-35 consists of 35 questions that are scored on a 3-point Likert scale ranging from 0 (never) to 2 (often). The PSC-35 includes three subscales that measure attention and internalizing and externalizing problems. The total PSC-35 score is obtained by summing the scores of individual items and ranges from 0 to 70, with higher scores indicating higher levels of caregiver-perceived psychosocial impairment in children.
Caregiver psychological distress will be measured using the Kessler Psychological Distress Scale (K6) [36]. The K6 consists of six questions pertaining to participants mental health in the previous week, which are scored on a scale from 1 (all of the time) to 5 (none of the time). Total scores range from 6 to 30, and are obtained by summing the individual items. Higher scores indicate higher levels of psychological distress.
The Alabama Parenting Questionnaire-42 (APQ-42) will be used to assess parenting behaviours [37]. The APQ-42 measures 5 parenting constructs: (1) involvement (10 items), (2) supervision and monitoring (10 items), (3) positive parenting (6 items), (4) consistent discipline (6 items), and (5) corporal punishment (3 items). The remaining 7 items assess other disciplinary practices. All items are rated on a 5-point scale ranging from 1 (never) to 5 (always), and scores are calculated for each construct by taking the sum of the relevant items.
In Lebanon only, a caregiver SUQ was also developed, which consists of 8 items related to the use of effective caregiver coping and parenting strategies (identifying emotions in child, comforting child, spending quality time, using praise with children, using harsh discipline, and stress reduction techniques). Each item is scored on a frequency scale ranging from 0 (never) to 4 (all of the time).
In Lebanon, where a caregiver has multiple children in the study, the APQ-42, K6, and caregiver SUQ will only be completed once by the caregiver, while the caregiver-report PSC-35 will be completed separately for each child.
Other measures
In order to measure traumatic exposure in children as a demographic characteristic, and possible moderator of treatment effects, we developed a 27-item traumatic events checklist to be delivered to caregivers (at T0 only). The list was developed by pooling items from a range of common trauma checklists (Harvard Trauma Questionnaire [38], University of California Los Angeles Post Traumatic Stress Disorder Revised Inventory [39], Child Posttraumatic Stress Disorder Symptom Scale [40], and Trauma Checklist [41]), and by working with local Lebanese child and adolescent mental health professionals to determine the relevance and acceptability of each item and completeness of the checklist overall, resulting in removal or rephrasing of some items. Each item is scored as “yes” or “no” for occurrence, regardless of when it occurred (in Syria, during migration, or in the current location).
To ensure participant retention in the study we aim to keep detailed address and contact information, and discuss the current location with community members if participants have moved.
Facilitator selection, training, and supervision
Each EASE intervention will be conducted by two trained facilitators. EASE facilitators will be male and female non-specialist providers recruited from the Institute for Family Health or War Child Holland. They will receive 8 days of training in basic counselling skills, delivery of EASE, group facilitation, and self-care. Additionally, all trained facilitators will be required to complete a practice cycle of the EASE intervention under close supervision. Following training, all facilitators will undergo an assessment of competencies in order to be eligible to implement the intervention. Weekly supervision will be provided by local trainers. These trainers will receive a training-of-trainers, which will include conducting their own EASE intervention groups. They will also receive training in supervisory techniques, in order to ensure protocol adherence. In addition, trainers will receive regular supervision with an EASE master trainer, a clinical psychologist (AM, FB, or MA), to ensure treatment adherence and provide support.
ETAU facilitators will be recruited using the same criteria and process as EASE facilitators. They will receive 3 days of training in delivering the scripted session, basic counselling and communication skills, and self-care. At the end of training, a role-play competency assessment will be conducted. Given the single-session nature of ETAU, facilitators will receive one group supervision session mid-way through implementation of the sessions, and a group debrief and feedback session once all intervention sessions are completed.
Sample size
The sample size calculation was based on a two-group comparison of the primary outcome at the 3-month follow-up time point. Given that this study is an individually randomised group-treatment trial, it is expected that there will be clustering in the EASE arm due to the group-based delivery of the intervention. Therefore, the sample size should account for this clustering and the potential inflation of outcome variance in the EASE intervention arm. The methods of Moerbeek and Teerenstra (2015) [42] were used, (specifically, eq. 8.14), in order to provide the estimated sample size required in the control arm, given that the following parameters are known: the number of EASE groups (n2), the number of members of each group with data at the 3-month follow-up time point (n1), the effect size (delta, which is assumed to be the mean difference between arms scaled by the standard deviation in the control arm), the ratio of variance in the EASE arm versus the control arm (theta), and the intracluster correlation coefficient (rho) [43].
In order to obtain estimates for the variance parameters, a small pilot data set from Jordan and Lebanon was used. A conservative estimate of theta (ratio of variances) was 1.1 and of the intraclass correlation was 0.13. Assuming 20 EASE groups of 6 people each at the 3-month follow-up time point, and additionally assuming a 5% two-tailed significance test and 80% power, it is estimated that data from 191 participants in the control arm would need to be available at the 3-month follow-up time point in order to detect an effect size of 0.4. This would correspond to an overall sample size of 311 at 3 months, and an allocation ratio of EASE to ETAU arms of 1:1.6. Allowing for 30% loss to follow up, then the sample size required at enrolment would be approximately 445.
Statistical analysis
All analyses will be detailed in a statistical analysis plan, which will be signed before unmasking the study data set. Data will be downloaded from the Kobo data collection software and imported into statistical analysis software for data management and analysis. Details of data security and storage can be found in ethical protocols, which are available on request.
To determine comparability between the conditions at baseline, multiple planned comparisons will be conducted for continuous variables and chi squared tests for categorical ones. For hypothesis testing, hierarchical linear modeling (HLM) analysis will be carried out to assess differential change over time in measurement scores between groups. For each outcome, the effects of time of measurement, group, and the group-by-time interaction will be analysed. HLM presumes intent-to-treat analyses, as HLM allows the number of observations to vary between participants and effectively handles missing data. Time (linear and quadratic), treatment condition, and their interaction will be included in the models. Fixed-effects parameters will be tested for intervention conditions, and time of assessments at 95% confidence intervals. The level 1 model will represent within-patient change over time, and the level 2 model will predict variation in within-patient change over time and encompass between-patient variables. Covariates will be added as necessary, including age and gender. Adjustments for clustering at the level of treatment group and sibling (for Lebanon only) will be made during analysis.
Analysis will focus on the primary outcome (PSC-35 youth report) and secondary outcomes of EASE and ETAU, with the main outcome point being the 3-month follow up, relative to baseline. Completers analyses will also be conducted using only the data on participants completing the allocated intervention as planned. In addition to the primary analysis, subsequent analyses will be conducted to explore the roles of potential moderators and mediators on outcomes (independent from primary analyses). Across all analyses, two-tailed tests will be reported with a significance level of p < 0.05.
Implementation and trial management
Fidelity of EASE and ETAU
Facilitator pairs will complete a session checklist at each EASE or ETAU session to evaluate treatment fidelity. A sample of 10% of the EASE sessions will be observed by a trained staff member, who will complete a structured observation form to score which elements of the programme have been carried out by the facilitator, and to what quality. Similarly, a sample of 10% of ETAU sessions will be observed and a checklist completed.
The competency of the EASE facilitators will be tested before and after participation in training, using a modified version of the Enhancing Assessment of Common Therapeutic factors (ENACT) rating scale for training and supervision [44]. The ENACT scale is an 18-item assessment for common factors in psychological treatments, including task-sharing initiatives with non-specialists across cultural settings. We will utilize 5 of the items for this trial. Four competency items will also be assessed during each session observation.
Blinding
Participants and implementation staff will not be blind to participant allocation. The research assistant team will remain blind to the intervention allocation of children throughout the trial, and will operate independently from the intervention facilitators. All staff have been trained and supervised in the importance of maintaining blinding, and at no time will intentional unblinding of the research assistants be required. Prior to conducting each T1, T2, and T3 assessment, instructions will be given by research assistants to all participants about the importance of not revealing their allocation. In the case that the allocation is revealed, research assistants will be instructed to inform the research coordinator immediately and another research assistant will complete the assessment with that participant. At the end of each T1, T2, and T3 assessment, research assistants will provide a guess as to which treatment the participant received - if blinding was maintained, these guesses should be no better than chance.
Contamination
In Lebanon, in order to assess the extent of contamination across EASE and ETAU arms, participants in both the EASE and ETAU arms will be asked several structured questions at T1 and T2 about the extent to which they shared information and materials about the treatment received with others in the community, and whether they have heard about the other treatment and materials from others. This information will be used descriptively to determine contamination.
Trial monitoring
In each site, a trial management committee consisting of principal investigators, co-investigators, and research coordinators will regularly monitor the implementation of study procedures. All adverse events (AEs) (e.g. injuries on the way to treatment, increase in distress) and serious adverse events (SAEs) (e.g. suicide attempts, serious violence) will be recorded by the research team and reported to a site-specific Data Safety Management Board (DSMB). Meetings will be facilitated by the study coordinator, but the board will consist of three or more local professionals, external to the study, but with experience in similar research. The PI in each site will be responsible for reporting (S)AEs to the board, and also to relevant ethics committees. The chair or a nominated person from the advisory board will review SAEs within 48 h and the advisory board will review all AEs once a month and where necessary to determine any appropriate action in respect of ongoing trial conduct. Information is included on the informed consent form to inform participants that the field coordinator or another clinician other than their therapist are available to them if they are upset by this study. If necessary, appropriate action will be taken with respect to individual participants or conduct of the trial (such as referral to specialised care, installing extra assessment points for monitoring participants, or discontinuation). No interim analyses are planned. The local project coordinator is responsible for ensuring timely follow up of any (S)AEs, and will inform the participants and DSMB if any data indicate that the disadvantages of participation may be significantly greater than expected.
