UAMs are a particularly vulnerable population, facing significant risks due to the
compounded effects of trauma, displacement, and lack of family support. The study aims to
fill a critical gap in the literature by providing an empirical evaluation of TF-CBT for
this population, as no previous studies have utilized an RCT design to assess TF-CBT for
UAMs in the Greek context.
Study Objectives and Rationale The primary aim of this study is to empirically validate
the effectiveness of TF-CBT for UAMs with PTSD symptoms. Secondary objectives include the
adaptation of TF-CBT to the Greek cultural context, the development of guidelines for its
implementation, and the provision of professional training for psychologists working with
UAMs. The study will also assess the impact of TF-CBT on emotional well-being, PTSD
symptoms, and overall mental health. Given the growing refugee population in Greece and
the high levels of trauma experienced by UAMs, the need for culturally appropriate and
evidence-based mental health interventions is urgent.
Study Design and Methodology The study adopts a single-blinded, randomized controlled
trial pre-post design, to compare the intervention group (TF-CBT) with the control group
(TAU) and assess the efficacy of TF-CBT in accommodation centers and Supported
Independent Living (SIL) programs in Greece for UAMs. Effectiveness will be evaluated
through within-group comparisons of pre-treatment and post-treatment outcomes for the
intervention group, as well as between-group comparisons of the TF-CBT group (n = 30) and
the TAU group (n = 30). It is a multicenter study conducted across multiple refugee
accommodation centers and Supported Independent Living (SIL) programs throughout Greece.
Participants will be randomly assigned to either the intervention group (TF-CBT) or the
control group (TAU). The trial will be conducted at three key time points: baseline (T0),
immediately after the intervention (T1), and three months post-intervention (T2). Data
will be collected through structured questionnaires, including the Child and Adolescent
Trauma Screen (CATS) to evaluate trauma exposure and PTSD symptomatology, the Depression,
Anxiety, and Stress Scale - 21 items (DASS-21) to measure levels of depressive, anxious,
and stress-related symptoms, the Patient Health Questionnaire - 15 (PHQ-15) to assess
somatic symptoms, the Strengths and Difficulties Questionnaire (SDQ) to evaluate
emotional and behavioral difficulties and the World Health Organization - Five Well-Being
Index (WHO-5) to assess overall emotional well-being and quality of life. All tools will
be administered in languages familiar to the participants. Official or validated
translations will be used when available. These include Greek, English, French, Arabic,
Urdu, and Somali. Where validated translations are unavailable, community-based
translation and back-translation procedures (Beaton et al., 2000) will be applied, with
the assistance of trained volunteer interpreters to ensure cultural and linguistic
appropriateness.
While psychologists will oversee the assessment process to ensure it remains supportive
and non-intrusive, they will not have access to the assessment data or results.
Interpreters will be present when required to facilitate understanding, but they will not
participate in the assessment itself. All responses will be anonymized and used solely
for the purpose of evaluating the intervention's effectiveness.
Psychologists, who are employed by the accommodation centers and Supported Independent
Living (SIL) programs, will also be randomly assigned to the intervention or the control
group. Therapists of the intervention group will receive specialized training in TF-CBT
prior to the start of the study to ensure the highest quality of treatment and they will
administer TF-CBT intervention under supervision. The TAU approach involves minimal
intervention, consisting of routine clinical management and psychological support without
a structured therapeutic framework. Moreover, the study will be conducted in
collaboration with trained interpreters, to ensure that language barriers do not hinder
the delivery and evaluation of the intervention.
Demographic Data and Inclusion Criteria Participants in the study will be UAMs aged 15-18
years, currently residing in accommodation centers and Supported Independent Living (SIL)
programs in Greece. To be eligible for inclusion, participants should have arrived in
Greece as unaccompanied minors, be within the specified age range (15-18 years), have a
formal diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria, or
present with moderate to high levels of traumatic distress as indicated by the Child and
Adolescent Trauma Screen (CATS), have maintained a stable living arrangement for at least
2-3 weeks prior to the intervention, and not be scheduled for relocation or transfer
within the upcoming 2-3 months following the intervention's initiation. Exclusion
criteria include: Diagnosed intellectual disability (IQ < 70) or other developmental
disorders that may hinder participation, acute suicidality or recent severe
self-injurious behavior, significant risk of violence toward others, comorbidity with
bipolar disorder or psychotic disorders, and ongoing substance abuse or active addiction.
Demographic information collected at baseline from both participants and the
psychologists delivering the intervention will include age, gender, country of origin,
and native language.
Power Analysis The sample size for this study was determined based on an a priori power
analysis conducted using G*Power software. A two-tailed t-test for independent samples,
with equal group sizes, was selected as the statistical test. The significance level (α)
was set at 0.05, and the desired statistical power was 0.80, consistent with standard
practice.
The analysis indicated that, for an effect size (d) of 0.75, a minimum of 29 participants
per group would be required to achieve satisfactory power. Given this calculation, a
sample size of 30 children per group was determined to provide adequate statistical power
(1-β) to detect meaningful differences between groups at the specified effect size.
Data Collection and Statistical Analysis Data collection will be conducted electronically
using Google Forms, ensuring full confidentiality and participant anonymity. All
responses will be anonymized and utilized to evaluate the effectiveness of the
intervention across assessment time points.
Statistical analysis will be conducted using SPSS latest edition. Descriptive statistics
will summarize the key variables, and independent t-tests and chi-square tests will
assess baseline equivalence between the groups. To evaluate the effectiveness of the
intervention, a repeated measures ANOVA will examine the interaction between group
(intervention vs. control) and time (pre-intervention, post-intervention, and follow-up).
Effect size calculations (partial eta-squared and Cohen's d) will be used to quantify the
magnitude of observed effects.
Ethical Considerations The study will be conducted in full compliance with the
Declaration of Helsinki and has received ethical approval from the Ethics Review Board of
Panteion University in Athens, Greece. All participant data will be handled in accordance
with the General Data Protection Regulation (GDPR). Prior to participation, all
participants will provide informed consent, and psychologists will ensure that the
process is voluntary and anonymous. To protect participants' confidentiality, a personal
identification code will be used to link responses across time points without collecting
personal identifiable information. Data will be securely stored and only accessible by
the researchers involved in the study.
Challenges and Limitations Conducting RCTs in refugee populations presents unique
challenges, such as limited resources, high mobility of participants, and logistical
constraints. The transient nature of UAMs necessitates short follow-up periods, which may
limit the ability to assess long-term outcomes. Additionally, cultural and language
barriers may affect the implementation and interpretation of both the intervention and
assessment tools. However, this study will address these issues using culturally adapted
tools, translator verification, and flexible intervention protocols.
Expected Outcomes and Impact The study is expected to provide valuable insights into the
effectiveness of TF-CBT for UAMs, contributing to the development of evidence-based
guidelines and best practices for treating PTSD in this population. By improving mental
health outcomes and offering training for psychologists, the study aims to enhance the
quality of care for UAMs in Greece and other refugee-hosting countries. Furthermore, the
findings will inform future research on trauma-focused interventions for refugee
populations, with the potential for broader application across Europe and beyond.