Actively Recruiting
Developing Innovative PTSD Treatment for Children
Led by Viktoriia Gorbunova · Updated on 2025-11-21
40
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
V
Viktoriia Gorbunova
Lead Sponsor
C
Charitable Foundation Voices of Children
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is testing a new version of a treatment called the Reconsolidation of Traumatic Memories Protocol for Children (RTM-C Protocol). The RTM Protocol™ is already proven to help adults with post-traumatic stress disorder (PTSD) by reducing distressing memories, flashbacks, and nightmares. The children's version is specially adapted to meet the needs of children aged 6-14, using child-friendly language, games, and animated tools. The purpose of this study is to find out whether the RTM-C Protocol can safely and effectively reduce post-traumatic stress symptoms in children who have experienced trauma. We also want to know whether children, parents, and therapists find the method acceptable and easy to use. Children and their parents will take part in a series of sessions with a trained specialist. Parents will join an initial session to provide information and give consent. Children will then have up to six therapy sessions, during which they learn to safely "replay" their difficult memories in imaginative ways that reduce their fear. Parents and children will complete questionnaires about symptoms before and after the sessions, as well as at 1 and 6 months after completion. Study Question: Can the RTM-C Protocol reduce post-traumatic stress symptoms in children and improve their daily functioning (such as relationships, learning, and happiness)? Study Hypothesis: RTM-C Protocol will lead to a significant reduction in PTSD symptoms in children, with improvements maintained at follow-up, and will be rated as acceptable and feasible by children, parents, and therapists.
CONDITIONS
Official Title
Developing Innovative PTSD Treatment for Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6-14 years at enrolment.
- PTSD symptoms present: CATS-2 (Parent) total ≥15 at screening.
- Functional impact: impairment endorsed in ≥1 CATS-2 domain (relationships, leisure, learning, happiness).
- Consent/assent: written parent/guardian consent and child assent obtained.
- Availability: child and caregiver can attend parent session + 6 treatment sessions and complete 1- and 6-month follow-ups.
- Language/comprehension: child can understand session instructions and participate in tasks (with supports as needed).
- Therapist check of readiness: during Session 1 practice, child demonstrates reliable break state (disengages from imagery, re-orients to present, maintains eye contact, relaxed affect).
You will not qualify if you...
- Acute comorbid mental disorder.
- Concurrent trauma-focused psychotherapy planned or ongoing during the study period.
- Inability to understand/follow instructions due to cognitive impairment or other reasons that preclude participation.
- Medical/neurological condition or situational factors (e.g., inability to commit to visits) that, in the investigator's judgment, would make participation unsafe or compromise study integrity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charitable Foundation Voices of Children
Kyiv, Ukraine
Actively Recruiting
Research Team
V
Viktoriia Gorbunova, ScD
CONTACT
T
Tetiana Shiriaeva, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here