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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Ukraine
Charitable Foundation Voices of Children
RECRUITING
Kyiv
Contact Information
Primary
Viktoriia Gorbunova, ScD
viktoriyka.gorbunova@gmail.com
+380931316322
Backup
Tetiana Shiriaeva, PhD
tetiana.shyriaeva@gmail.com
Time Frame
Start Date: 2025-09-20
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 40
Treatments
Experimental: Reconsolidation of traumatic memories in Children (RTM-C)
Experimental: RTM-C Protocol. All participants will receive the RTM-C Protocol intervention, an adapted version of the adult RTM Protocol™ designed for children aged 6-14 with post-traumatic stress symptoms. Parents and children complete follow-up assessments at 1 and 6 months to measure outcomes.
Related Therapeutic Areas
Sponsors
Collaborators: Charitable Foundation Voices of Children, Quresta, Inc.
Leads: Viktoriia Gorbunova

This content was sourced from clinicaltrials.gov