Developing Innovative PTSD Treatment for Children

ConditionPost Traumatic Stress Disorder PTSD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-14

SponsorViktoriia Gorbunova

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Reconsolidation of traumatic memories in Children (RTM-C)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Viktoriia Gorbunova

Lead sponsor

Global Institute for Mental Health Innovations, Networking and Development a.s.b.l.

Sponsor institution

Charitable Foundation Voices of Children

Collaborator

Quresta, Inc.

Collaborator

Source ClinicalTrials.gov

Apply now