Developing Innovative PTSD Treatment for Children: Reconsolidation of Traumatic Memories Protocol™ for Children (RTM-C Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in post-traumatic stress symptoms (CATS-2 total score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Reconsolidation of traumatic memories (Behavioral)
结局指标
主要结局
Change in post-traumatic stress symptoms (CATS-2 total score)
时间窗: 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.
次要结局
未报告次要终点
研究者
Viktoriia Gorbunova
Vice President
Global Institute for Mental Health Innovations, Networking and Development a.s.b.l.