Problem Management Plus With Emotional Processing (PM+EP) for Forcibly Displaced Youth

Study Procedure

Potential participants will be approached through Save the Children and other non-government organizations (NGOs), varied community sources, including service providers, and social media. Given the locations of Save the Children activities, in-person recruitment efforts through will primarily focus on Stockholm, Malmo, and Gothenburg regions. All participants will provide oral and written informed consent, either in Swedish or in their native language, depending on preference, prior to taking part in the screening process. For participants aged 16 - 17, the individuals will be asked to provide contact details to their parents before assessment to make sure that we can contact the parents in case of that the child describes severe symptoms such as suicidal ideation at the assessment. The participants will also get written information about the study to provide to their parents. For potential participants with literacy difficulties, a witnessed thumb print will be collected in lieu of written consent, according to WHO guidelines. Prior to participation, it will be ensured that consenting participants are fully aware of what it means to participate in the trial and that they have the autonomy to withdraw their consent at any time without having to give an explanation. It will also be made abundantly clear that for those who refuse to participate, it will not have an impact on any other types of support that they may be receiving or have access to in the community through community and non-governmental organization initiatives. Consenting participants will be invited to complete self-report screening assessments which includes the capture of basic socio-demographic data and the following measures: K10, WHODAS 2.0, and WHO PM+ suicide screening tool. Following the screening procedures, an assessor will determine whether the participants met the inclusion or exclusion criteria. For participants who did not screen positive for psychological distress, assessors will provide them with feedback indicating that they are dealing with their stress in a healthy manner; if participants express further concern, they will be informed of resources on available services and psychosocial support options in their communities. Those who are excluded due to meeting one of the exclusion criteria, indicative of more severe problems, will be referred to child- and adolescent or adult psychiatric services, depending on their age.

Eligible participants will be invited to participate in the trial and to complete a baseline assessment either live or by teleconferencing (Table 1). Participants will complete measures examining the following constructs: anxiety and depression (Hopkins Symptom Checklist-25; HSCL-25), PTSD (PTSD Checklist for DSM-5; PCL-5), self-identified problems (Psychological Outcomes Profile; PSYCHLOPS), well-being (WHO-5 Well-being Index; WHO-5), social support, agency (State Hope Scale for Adolescents; SHS-A), and health care services recently received (Client Service Receipt Inventory; CSRI). In addition, participants will complete checklists indicating pre- and post-migration stressors. All screening and baseline assessments will be completed during Save the Children work hours (08:00 - 16:00) to ensure that appropriate referrals are able to be made according to their standard operating procedures if imminent risk of suicide is expressed during the assessments. Following the completion of the baseline assessment, participants will be randomized as described in detail below.

Following randomization, if participants are to receive the PM+ or PM+EP intervention, they will be contacted by either a PM+ or PM+EP facilitator who will schedule the upcoming six sessions. If participants are to receive CAU, they will receive a phone call from a Save the Children employee and be referred to Save the Children's programs/other programmes locally providing psychosocial care. Following both the completion of the baseline assessments and randomization, participants will be contacted to organize the first session within seven days. The first session will take place no longer than two weeks following the baseline assessments. Participants will be given the choice as to whether they prefer the PM+/PM+EP intervention to be provided in-person or through teleconferencing. If during the study there are any COVID-19/pandemic related restrictions or other reasons stated by the participants that require remote administration of the intervention, teleconferencing will be used. The post-intervention assessment will take place within two weeks after completion of the sixth and final session (participants can take up to 11 weeks to complete six sessions). The post-assessments will include the WHODAS 2.0, HSCL-25, PCL-5, PSYCHLOPS, CSRI, WHO-5, social support, and SHS-A assessments. The follow-up assessment will be conducted three months after the sixth PM+ session (i.e. 18 weeks after baseline). The assessment will be identical to the post-intervention assessment but will additionally include the checklists that were collected during the baseline assessments.

Randomisation

Randomisation will be conducted by an independent researcher not involved in the study following the participants completion of the baseline assessment. The randomization sequence will be generated by electronic software with a 1:1:1 allocation ratio between PM+, PM+EP, and CAU; randomization will be stratified by participant language and region of recruitment. Following randomization, the participant will be connected with either a PM+ or PM+EP helper, or CAU facilitators who will then independently plan the upcoming intervention schedule. As this is a single-blind RCT, the assessors who will collect pre-, post-, and follow-up data will not be aware of which form of PM+ participants received during their treatment and where possible a different assessor will conduct each of the three assessments for a given participant. For follow-up assessments, the assessors will be asked to provide a guess as to which intervention the participant received and to disclose if the participant said which intervention they received.

Assessors

Trained and supervised assessors will carry out the consent, screening, and assessment procedures throughout Study Phase 1. The assessors will be recruited through Save the Children Sweden and receive a two-three day training on questionnaire administration, basic interviewing skills, common mental disorders, psychological first aid (PFA), and research ethics. There will be at least one assessor who is able to speak each language of the included participants. All assessors will be fluent in Swedish.

Sample Size

The primary aim of the feasibility RCT is to better understand the intervention and research procedures and is not intended to determine the effectiveness of the interventions. In turn, no power calculations have been carried out and the final sample size was based on previous feasibility trials of similar interventions, including the initial trials of Problem Management Plus A total number of 60 individuals, 20 per arm, will be included in the study which will allow us to evaluate the feasibility and acceptability of the PM+ and PM+EP interventions in Sweden.

Instruments

Assessment responses will be collected through REDcap, a digital medical research platform that will allow for the coding of questionnaires in multiple languages for ease of data collection and subsequent analysis.

Screening measures

The WHO Disability Assessment Schedule (WHODAS 2.0) socio-demographic and disability assessment questionnaires will both be collected at screening. The socio-demographic questionnaire will be used to collect information on age, gender, asylum status, marital status, education and work status, and living conditions. The WHODAS 2.0 is a questionnaire developed to measure health and disability corresponding to the following six domains: 1) cognition, 2) mobility, 3) self-care, 4) getting along, 5) life activities, and 6) participation. The 12-item version, which has been used more commonly as a screening-tool will be used to understand levels of impaired functioning. Scores are rated on a 1 (none) to 5 (extreme) scale (range: 12-60), with higher scores indicating worsened levels of functioning. A score of higher than 16 will be used to indicate decreased functionality. Minor adaptations of the questions have been made for this study to better suit youth; for example 'taking care of your household responsibilities?' was changed into 'Participating in household chores'. Community activities listed under item 4 (festivities, religious or other activities) were replaced with clubs, after school activities, religious or other activities.

The Kessler Psychological Distress Scale, 10-item version (K10) will be used to screen for levels of psychological distress. Items are scored on a scale of 1 (none of the time) to 5 (all of the time) with higher scores indicating higher levels of distress experienced in the preceding month (range 10 - 50). The K10 has been used extensively in adult populations and norms are available for young children aged 10 years old. Additionally, there are a number of studies that have validated the scale in adolescent populations. To align with other PM+ studies of refugees residing in HIC, we will use a cut-off score of 15 to indicate moderate levels of psychological distress.

Finally, imminent risk of suicide will be assessed using the three-item WHO PM+ suicide screener. The first question posed to participants is whether "in the past month have \[they\] had serious thoughts or a plan to end your life?". If the participant says no to this question the questionnaire will end and participants will be invited to participate in the trial dependent on their WHODAS 2.0 and K10 scores. If the participant says yes, two additional questions will be asked: (1) "Have you taken actions to end your life" and (2) "Do you plan to end your life in the next two weeks?". If the participant does not answer yes to these two questions they will be included in the study and this information will be flagged to their PM+ facilitator when providing support. If the participant does answer yes to any of the two additional questions, parents will be contacted for those under 18 years of age, and they will be referred to the emergency child psychiatric services immediately. If the parent is unable to assist the child and is not willing to accept further assistance, social services will be contacted. For adults older than 18 years of age, they will be referred to emergency psychiatric services. Transportation services will be contacted if needed.

Feasibility measures

The primary outcome of this study will be the feasibility and acceptability of the delivery of PM +EP in refugee youth. Feasibility will be decided on using the following criteria: a) 70% recruitment and consent rates, b) 70% attendance of sessions and assessments, c) 75% protocol adherence, d) maximum 10% presence of adverse events and no serious adverse events, e) fewer than 15% missing items on outcome measures, and f) qualitative assessments from the process evaluation.

Protocol adherence will be determined through two methods. The first is a self-rating fidelity checklist that will be filled out by the PM+/PM+EP facilitators at the end of each session. This will contain each of the elements from the completed session and facilitators will be asked to identify what items they completed and which items they may have missed to assess the degree of fidelity to the manualized intervention. Secondly, audio recordings of sessions will be taken if participants provide informed consent for recording. A random same of 10% of recordings will be scored independently by two research assistants. The interrater reliability for the audio recordings will be computed.

Secondary outcome measures

Secondary outcome measures will be administered

• WHO Disability Assessment Schedule (WHODAS 2.0) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Hopkins Symptom Checklist-25 (HSCL-25) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Self-identified problems (PSYCHLOPS) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Client Service Receipt Inventory [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Bonding social capital [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Subjective Wellbeing (WHO-5) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• State Hope Scale - Agency Subscale (SHS-A) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]
• Post Migration Living Difficulties (PMLD) [Срок оценки: From enrollment to the end of assessment prior (18 weeks)]