Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan

The study will be conducted in districts of Amman (Jordan) that have high proportions of residing Syrian refugees. There are currently over 660,000 Syrians registered with United Nations High Commissioner for Refugees (UNHCR) as refugees [21], with the government estimating a total of 1.4 million Syrians residing within Jordan at the current time [22]. The study will be implemented by the Institute for Family Health, a national non-governmental organization (NGO).

The study will be conducted in community centres in two governorates of Lebanon-North and Akkar. Lebanon hosts the highest number of refugees per capita, with a current estimate at 1.5 million Syrians, in addition to large numbers of Palestinian refugees (with total national population at 5.9 million) [23]. Lebanon has experienced prolonged internal conflict, external invasions and military assaults, and occupation in recent decades, leading to challenges of limited basic infrastructure, political instability, and struggling economy. Therefore, the Syrian crisis and this rapid and large increase in the population over a short period of time has meant that the ability to meet educational, health, financial, and mental health needs of the population is limited. In areas where Syrian and Palestinian refugees settle, many vulnerable Lebanese families also face similar adversity and lack of services. Most recent estimates indicate only 1.26 psychiatrists and 3.42 psychologists per 100,000 population, with 97% working in the private sector, making mental healthcare largely inaccessible to the most vulnerable [24]. The implementing agency for the study will be War Child Holland, in collaboration with the Ministry of Public Health. War Child in Lebanon has been actively responding to the Syria emergency crisis since early 2012 in the areas of protection, education, and psychosocial support services, providing programmes directly, or through community-based organizations. The study will take place in locations where War Child has active programming.

After identifying households occupied by Syrian refugees, the assessors will ask to meet with the head of the household. After a brief explanation about the purpose of the survey, they will ask permission to interview one child aged 10–14 years that is currently residing with them. If there are multiple children in this age range residing in the household, the caregiver will be asked which child they would like to take part in the screening.

Community engagement and sensitization will involve meetings with relevant community stakeholders to provide them with a basic understanding of the EASE study and to gain their support in the outreach and recruitment process.

Various outreach and recruitment strategies will be used to ensure that eligible children living within the targeted communities are aware of the study and invited to participate. Strategies are expected to include identifying potentially eligible adolescents in active War Child programmes, hosting community awareness sessions, communicating about the study via social media pages frequently used by refugee communities, communicating via other NGO and United Nations partners working in the area, and asking community leaders to ensure all eligible children are given the opportunity to take part. Recruitment will be guided by a script in order to minimize any bias in recruitment amongst the strategies. Adolescents and caregivers meeting inclusion criteria will be registered and invited to attend the screening interview.

EASE is a group psychological intervention, developed by the WHO based on empirically supported strategies recommended by the WHO for emotional disorders in children and young people. The intervention consists of seven 90-min group sessions for adolescents and three 90-min group sessions for their caregivers. Adolescent sessions involve the following strategies: psychoeducation, problem solving, stress management (slow breathing), behavioural activation, and relapse prevention. The caregiver sessions involve psychoeducation, active listening, quality time, praise, caregiver self-care, and relapse prevention. During caregiver sessions, another staff member will be available to provide child care as necessary. Caregiver sessions are scheduled so that the first should occur before the third child session, the second should occur before the fifth child session, and the third should occur before the last child session. More details about the EASE intervention and development have been previously reported [17].

Treatment as usual for Syrian refugees in Jordan, and adolescents living in vulnerable communities in Lebanon, usually consists of no intervention. For this study, the comparison group will receive enhanced treatment as usual, which will involve the provision of a single-session, psychoeducation, home visit termed “Psychoeducation for Young Adolescents”. Both the adolescent and caregiver will be invited to the psychoeducation session (of approximately 30 min duration) in which they will receive brief feedback that the youth indicated psychological distress, as well as scripted psychoeducation about (1) self-care strategies and (2) seeking services from local health or community services offering mental health and psychosocial support services. In situations where either the child or caregiver remain concerned about their psychological distress, they will be encouraged to seek support through local community organizations. ETAU participants will not be offered EASE for the duration of their enrolment in the study.

Participants will not be prevented from taking part in other interventions during the trial period. In Lebanon, as part of funding arrangements with partners, we will ask participants at T1, T2, and T3 about their health service usage.

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).

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.

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 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.

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.

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.

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.