Developing Innovative PTSD Treatment for Children

NCT07185126 | Recruiting DMC

• 1 other identifier: № 07062025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

RTM; Reconsolidation of Traumatic Memories; PTSD; Post Traumatic Stress Disorder; Children

Outcome Measures

Primary Outcomes (1)

• Change in post-traumatic stress symptoms (CATS-2 total score)

  The primary outcome is the change in total PTSD symptom severity, measured by the Child and Adolescent Trauma Screen - 2 (CATS-2). Both child self-report and parent-report versions will be administered. The CATS-2 assesses frequency of PTSD symptoms such as intrusive memories, nightmares, hyperarousal, avoidance, and negative thoughts/emotions. The CATS-2 is a validated screening and outcome tool for children and adolescents exposed to trauma. Change in CATS-2 total score reflects clinical improvement in PTSD symptoms and is the most direct measure of RTM-C effectiveness.

  Baseline (pre-intervention, Session 1), 1-month follow-up, and 6-month follow-up.

Study Arms (1)

Reconsolidation of traumatic memories in Children (RTM-C)

EXPERIMENTAL

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.

Behavioral: Reconsolidation of traumatic memories

Interventions

Reconsolidation of traumatic memories BEHAVIORAL

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.

Reconsolidation of traumatic memories in Children (RTM-C)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Viktoriia Gorbunova: lead
• Charitable Foundation Voices of Children: collaborator
• Quresta, Inc.: collaborator

Study Sites (1)

Charitable Foundation Voices of Children

Kyiv, Ukraine

RECRUITING

Related Publications (3)

• Astill Wright L, Horstmann L, Holmes EA, Bisson JI. Consolidation/reconsolidation therapies for the prevention and treatment of PTSD and re-experiencing: a systematic review and meta-analysis. Transl Psychiatry. 2021 Sep 3;11(1):453. doi: 10.1038/s41398-021-01570-w.

  PMID: 34480016 RESULT

• Sturt J, Rogers R, Armour C, Cameron D, De Rijk L, Fiorentino F, Forbes T, Glen C, Grealish A, Kreft J, Meye de Souza I, Spikol E, Tzouvara V, Greenberg N. Reconsolidation of traumatic memories protocol compared to trauma-focussed cognitive behaviour therapy for post-traumatic stress disorder in UK military veterans: a randomised controlled feasibility trial. Pilot Feasibility Stud. 2023 Oct 13;9(1):175. doi: 10.1186/s40814-023-01396-x.

  PMID: 37833734 RESULT

• Gorbunova V, Hampton R. The Reconsolidation of Traumatic Memories Protocol's adjustments to the remote treatment of injured Ukrainian military personnel in hospital settings. Eur J Psychotraumatol. 2025 Dec;16(1):2499410. doi: 10.1080/20008066.2025.2499410. Epub 2025 May 19.

  PMID: 40387497 RESULT

Related Links

• GlobalinMind Announcement of the Project
• Voices of Children Announcement of the Project

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Viktoriia Gorbunova, ScD

  Global Institute for Mental Health Innovations, Networking and Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoriia Gorbunova, ScD

CONTACT

+380931316322; viktoriyka.gorbunova@gmail.com

Tetiana Shiriaeva, PhD

CONTACT

tetiana.shyriaeva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President

Model Details: This is a non-randomized, single-arm interventional pilot study. All participants will receive the RTM-C Protocol. Following the parent session (for consent and orientation), children will complete six structured RTM-C Protocol sessions, followed by diagnostic assessments at 1 and 6 months. This pilot study uses an open-label design with no masking, as the intervention requires active therapist and child engagement. The primary purpose is treatment: to test whether the RTM-C Protocol reduces post-traumatic stress symptoms and improves child functioning, while also assessing feasibility and acceptability among children, parents, and providers.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 22, 2025
• Study Start: September 20, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)