RecruitingNot ApplicableNCT07185126

Developing Innovative PTSD Treatment for Children

Developing Innovative PTSD Treatment for Children: Reconsolidation of Traumatic Memories Protocol™ for Children (RTM-C Protocol)


Sponsor

Viktoriia Gorbunova

Enrollment

40 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 14 Years

Inclusion Criteria7

  • 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).

Exclusion Criteria4

  • 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.

Interventions

BEHAVIORALReconsolidation of traumatic memories

The intervention begins with a parent session to review history, provide orientation, and obtain consent. Each child then attends six individual therapy sessions with a trained RTM specialist. Sessions use imagination exercises, "film-like" replay of traumatic memories in modified formats (e.g., black-and-white, fast-forward, backwards), and structured state-interruption techniques to reduce fear and distress. Animated instructions and cardboard "cinema" and "skreen" models may be used to support comprehension if needed.


Locations(1)

Charitable Foundation Voices of Children

Kyiv, Ukraine

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NCT07185126


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