跳至主要内容
临床试验/NCT06878092
NCT06878092招募中不适用

Feasibility and Acceptability of Problem Management Plus With Emotional Processing (PM+EP) for Forcibly Displaced Youth Living in Sweden

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Feasibility and acceptability

研究概览

简要总结

The goal of this feasibility randomized controlled trial is to learn about the feasibility and acceptability of scalable psychological interventions in Sweden. It will also allow for a preliminary exploration of a novel modular addition targeting traumatic stress to Problem Management Plus (PM+), an evidence-based transdiagnostic psychological intervention for psychological distress.

The main question it aims to answer is whether PM+ and PM+ Emotion Processing (PM+EP) feasible and acceptable among forcibly displaced youth in Sweden?

Participants will be randomized to receive PM+, PM+EP, or treatment as usual. The two intervention arms consist of a weekly session for six weeks.

Assessments will collect data on a variety of psychological symptoms, wellbeing, and service use throughout the duration of the study. Assessments will take place at baseline, 1-week post-intervention, and 3-weeks post-intervention.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •16 to 25 year old youth who arrived in Sweden in 2015 or later due to being forcibly displaced;
  • •Elevated levels of psychological distress as determined through the Kessler-10 psychological distress scale (K10; K10 > 15);
  • •Reduced levels of psychosocial functioning as measured by the WHO Disability Assessment Schedule (WHODAS 2.0; WHODAS 2.0 > 16);
  • •Assessment and manual are available in their preferred language, including Swedish.

排除标准

  • •An acute medical condition;
  • •Imminent suicide risk;
  • •Indication of psychotic disorders and substance-dependence;
  • •Indication of severe cognitive or neurological impairment;
  • •Receiving specialized mental health treatment;
  • •In case of current psychotropic medication used: change in dosage during the past two months.

研究组 & 干预措施

Problem Management Plus with Emotional Processing (PM+EP)

Experimental

干预措施: Problem Management Plus with Emotional Processing Module (PM+EP) (Behavioral)

Problem Management Plus

Active Comparator

干预措施: Problem Management Plus (PM+) (Behavioral)

Treatment as Usual

Other

干预措施: Care as usual (Other)

结局指标

主要结局

Feasibility and acceptability

时间窗: From enrollment to the end of assessment prior (18 weeks)

* 70% recruitment and consent rate * 70% attendance of sessions and assessments * 75% protocol adherence * Maximum 10% presence of adverse events and no serious adverse events * Fewer than 15% missing items on assessments

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aemal Akhtar

Principal Investigator

Karolinska Institutet

研究点 (1)

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