Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT

NCT06975280 | Recruiting

• 1 other identifier: 40/4-10-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This single-blinded, multicentered, randomized controlled trial aims to evaluate the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) compared to Treatment-as-Usual (TAU) in reducing post-traumatic stress symptoms among unaccompanied refugee minors (UAMs) residing in accommodation centers and Supported Independent Living (SIL) programs in Greece. Participants aged 15-18 will be randomly assigned to either a TF-CBT intervention group or a TAU control group. The intervention will be delivered by trained psychologists under supervision and culturally adapted to the Greek refugee context. Assessments will occur at baseline, post-intervention, and three months later, using standardized psychometric tools. Secondary outcomes include changes in comorbid psychiatric symptoms (depression, anxiety, somatic symptoms), emotional and behavioral difficulties, and quality of life. The study also investigates potential moderators of treatment response such as age, gender, trauma history, and psychiatric comorbidity.

Conditions

Post-Traumatic Stress Disorder (PTSD); Depressive Symptoms; Anxiety Symptoms; Somatic Symptoms; Emotional and Behavioral Difficulties

Keywords

Unaccompanied minors; Refugee adolescents; Trauma-Focused Cognitive Behavioral Therapy; TF-CBT; PTSD; Depression; Anxiety; Child trauma

Outcome Measures

Primary Outcomes (1)

• Child and Adolescent Trauma Screen (CATS)

  A standardized measure used to assess trauma-related symptoms in children and adolescents. This tool is used as the primary outcome to evaluate changes in trauma symptoms following the intervention.

  Initial assessment (baseline), assessment immediately following the intervention, and a follow-up assessment 3 months after the intervention.

Secondary Outcomes (4)

• DASS-21: Depression, Anxiety, and Stress Scale

  Initial assessment (baseline), assessment immediately following the intervention, and a follow-up assessment 3 months after the intervention.

• Strengths and Difficulties Questionnaire (SDQ)

  Initial assessment (baseline), assessment immediately following the intervention, and a follow-up assessment 3 months after the intervention.

• PHQ-15: Physical Health Questionnaire

  Initial assessment (baseline), assessment immediately following the intervention, and a follow-up assessment 3 months after the intervention.

• WHO-5 Well-Being Index

  Initial assessment (baseline), assessment immediately following the intervention, and a follow-up assessment 3 months after the intervention.

Study Arms (2)

Intervention Group (TF-CBT)

EXPERIMENTAL

Participants in this arm will receive a structured therapeutic protocol based on trauma-focused cognitive behavioral therapy (TF-CBT), delivered over 12 weekly or bi-weekly sessions by trained psychologists in accommodation centers and Supported Independent Living (SIL) programs across Greece. The intervention includes psychoeducation, relaxation techniques, affective modulation, cognitive restructuring, development of a trauma narrative and trauma processing, in vivo exposure, and strategies to enhance safety and future planning. The program is specifically adapted for unaccompanied asylum-seeking minors (UAMs) presenting with symptoms of PTSD.

Behavioral: Trauma - Focused Cognitive Behavioral Therapy

Control group (TAU)

ACTIVE COMPARATOR

Participants in this arm will receive the standard support services (Treatment as Usual) provided in the accommodation centers and Supported Independent Living (SIL) programs, including routine clinical management and general psychological support, without engagement in a structured therapeutic framework or participation in the trauma-focused intervention. Access to the regular psychosocial services available to all residents will remain unchanged.

Behavioral: Treatment as Usual (TAU)

Interventions

Trauma - Focused Cognitive Behavioral Therapy BEHAVIORAL

TF-CBT is a comprehensive, evidence-based, short-term therapeutic protocol aimed at reducing trauma-related symptoms in children and adolescents aged 3-18. The protocol consists of 12 double sessions conducted with both the child and their caregiver. Developed for children who have experienced sexual abuse and multiple traumas, TF-CBT has since been successfully applied to a variety of traumatic experiences. Core components of the protocol include psychoeducation, relaxation techniques, emotional regulation, cognitive processing, trauma narrative, in vivo exposure, conjoint child/caregiver sessions, and safety planning. The intervention is culturally informed and flexible to meet individual needs. Adjustments have been made in the context of unaccompanied minors (UAMs), where caregiver involvement is not feasible, due to specific circumstances in accommodation centers and Supportin Greece.

Also known as: Trauma-Focused CBT, TF-CBT

Intervention Group (TF-CBT)

Treatment as Usual (TAU) BEHAVIORAL

The Treatment as Usual (TAU) approach involves routine clinical management and psychological support, without the use of a structured therapeutic framework. This intervention consists of general, non-specific support provided by clinical staff, including informal counseling and monitoring of the child's psychological well-being. Unlike more structured therapeutic protocols, TAU does not follow a predefined set of interventions or techniques, allowing for a flexible and individualized approach, though lacking the formal therapeutic focus of interventions like TF-CBT.

Also known as: TAU

Control group (TAU)

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be unaccompanied upon arrival in Greece and aged between 15-18 years old.
• Being diagnosed with PTSD based on DSM-5 criteria. Young refugees with post-traumatic stress symptoms (PTSS), as delineated by high or moderate trauma-related distress in the Child and Adolescent Trauma Screen (CATS), will also be eligible to participate in the study.
• Reside in an accommodation center or SIL program for UAMs in Greece.
• Have a stable living arrangement for at least 2-3 weeks prior to the intervention.
• Not be expected to relocate within the 2-3 months following the start of the intervention.

You may not qualify if:

• a diagnosed intellectual disability (IQ \< 70) or another developmental disorder
• acute suicidality or life-threatening self-harm behavior
• significant risk of harm to others
• comorbidity with bipolar disorder or a psychotic disorder
• substance abuse.

Sponsors & Collaborators

• Theodora Anastasiou: lead
• Greek Ministry of Migration and Asylum: collaborator
• SOS Children's Villages: collaborator

Study Sites (1)

General Secretariat for Vulnerable Persons and Institutional Protection, Ministry of Migration and Asylum

Athens, 182 33, Greece

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Medically Unexplained Symptoms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vasiliki Yotsidi, PhD

  Panteion University

  STUDY CHAIR

Central Study Contacts

Theodora Anastasiou, PhD candidate

CONTACT

+306942883681; theodanastasiou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to group assignment (intervention vs. control), but investigators, care providers, and outcomes assessors are aware.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate in Clinical Psychology, Panteion University

Model Details: Participants will be randomly assigned to either the TF-CBT intervention group or the Treatment-as-Usual (TAU) control group, and both groups will be assessed at baseline, post-intervention, and 3-month follow-up.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: April 13, 2023
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

GR (1)