Developing Innovative PTSD Treatment for Children

Not Applicable

Not yet recruiting

• Conditions: Post Traumatic Stress Disorder PTSD

• Registration Number: NCT07185126
• Lead Sponsor: Viktoriia Gorbunova

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.

Detailed Description

Post-traumatic stress disorder (PTSD) in children is a serious mental health problem that can develop after exposure to traumatic events such as war, violence, displacement, accidents, loss of loved ones, or abuse. PTSD in children is associated with intrusive memories, nightmares, physiological hyperarousal, avoidance of reminders, irritability, concentration difficulties, and impairments in family life, schooling, and social relationships. Although evidence-based psychological treatments exist for adults, there remains a major gap in effective, developmentally appropriate, and scalable interventions for children.

The Reconsolidation of Traumatic Memories (RTM) Protocol™ is a brief, non-pharmacological intervention originally developed for adults with PTSD. It is based on cognitive and neurobiological models of memory reconsolidation and dissociation. The RTM Protocol™ uses imagery to help individuals safely reprocess traumatic memories through a series of dissociative and imaginative steps (e.g., replaying memories in black-and-white, running them backwards, speeding them up). This process reconsolidates the traumatic memory in a less distressing form, leading to a rapid reduction in flashbacks, nightmares, and distress responses. The RTM Protocol™ in adults has demonstrated strong clinical effectiveness across several clinical trials, with high acceptability and minimal risk of re-traumatisation.

The children's version of the RTM Protocol™ (RTM-C Protocol) retains the essential procedural components of the adult method but is carefully adapted to meet developmental needs. Adaptations include:

* Child-friendly language and explanations.

* The use of play-based and imaginative exercises.

* Animated instructional videos and a cardboard "cinema" and "skreen" models to guide children through visualisation steps.

* Additional therapist strategies for emotional support, grounding, and engagement.

* Structured parental involvement before, during and after treatment sessions.

RTM-C Protocol™ is designed to reduce post-traumatic symptoms without requiring children to recount painful details. It is therefore less burdensome and carries minimal risk of retraumatisation compared with traditional trauma-focused exposure therapies.

Study design and stages. This pilot study involves a mixed-methods evaluation. A single-arm pilot with approximately 40-48 children, each treated by one of 20-24 trained RTM Protocol specialists. Children will complete six RTM-C Protocol sessions (plus parental sessions and diagnostic follow-ups). Outcomes will be measured at baseline, post-treatment, 1 month, and 6 months after treatment. Qualitative feedback will also be collected from specialists through structured focus groups.

Intervention procedures. RTM-C Protocol involves six structured sessions with the child, preceded by a parent session and followed by diagnostic follow-ups (at 1 month and 6 months after treatment), with both children and parents, to assess sustained outcomes.

Each session lasts approximately 60 minutes and follows a detailed, structured protocol. Animated instructions and cardboard "cinema" and "skreen" models are used as supportive tools only when verbal instructions are insufficient. Therapists are trained to avoid unnecessary use of tools that could prolong the session or burden the child. Children are rewarded at the end of sessions with small positive reinforcements (stickers, drawings, short games) to enhance engagement.

Therapist training and fidelity. All providers are certified RTM specialists. They receive additional one-day training in the RTM-C Protocol. Fidelity is supported through the use of protocol texts, animations, and visual tools, and monitored by session checklists and coaching. Feedback from therapists on usability, language, and feasibility will be used to refine the protocol before larger rollout.

Safety considerations. The RTM-C Protocol emphasises "stress-free recall." Children are not asked to provide detailed verbal descriptions of traumatic events. The therapist interrupts immediately if distress arises and redirects the child's focus to a safe, neutral task. Work with traumatic material proceeds only once the child has demonstrated the ability to switch states reliably during practice (clear disengagement from imagery, reorientation to the present, ability to make eye contact, relaxed affect). These safeguards minimise the risk of re-traumatisation.

Data collection and measures. The study uses the CATS-2 (Child and Adolescent Trauma Screen) as the primary outcome measure, administered to both children and parents. The CATS-2 provides scores for PTSD symptoms and functional impairment in relationships, learning, leisure, and happiness. Additional brief questionnaires and structured interviews will assess acceptability and feasibility from both families and providers. Data will be collected at baseline, post-treatment, and at 1- and 6-month follow-ups.

Data protection. All identifying information is anonymised using codes. Personal data are securely stored in locked cabinets and password-protected computers in Ukraine. Anonymised datasets may be transferred via secure, certified platforms. Only trained RTM specialists have access to identified data. Researchers analyse only anonymised data.

Scientific hypothesis. The study hypothesises that the RTM-C Protocol will significantly reduce PTSD symptoms in children, with effects maintained at 1- and 6-month follow-ups, and that children, parents, and therapists will find the intervention safe, acceptable, and feasible.

Significance. If effective, the RTM-C Protocol will provide an innovative, scalable, and low-burden treatment for PTSD in children. It could address a major unmet need in child mental health, particularly in humanitarian and post-conflict contexts. The pilot study in Ukraine is a first step toward larger implementation and evaluation, and findings will contribute to global knowledge on child-appropriate trauma interventions.

Study Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study Start: 2025-09-20
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2026-02-20
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in post-traumatic stress symptoms (CATS-2 total score)	Baseline (pre-intervention, Session 1), 1-month follow-up, and 6-month follow-up.	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.

Trial Locations

Locations (1)

Charitable Foundation Voices of Children; 🇺🇦 Kyiv, Ukraine