跳至主要内容
临床试验/NCT05734547
NCT05734547招募中不适用

Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)

Norwegian Center for Violence and Traumatic Stress Studies2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
2
主要终点
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

研究概览

简要总结

The goal of this randomized controlled trial is to learn about how to effectively help children (aged 7-12) who have developed moderate symptoms of posttraumatic stress after exposure to trauma, and prevent development of more severe problems. The main research questions are:

  • Will the parent-led, therapist assisted treatment "Stepping Together for Children after Trauma" (ST-CT) be more effective, compared to usual care, in reducing symptoms of posttraumatic stress, depression and sleep disorders, and in improving daily functioning for children and their parents after trauma?
  • Is ST-CT implemented to the municipal first-line services cost-effective?
  • Will ST-CT prevent use of health care services and prescribed drugs in the long term?

The children and their non-offending caregivers will be randomized to receive treatment with ST-CT or usual care, and symptoms and general functioning will be assessed at five time-points.

详细描述

Childhood trauma is a major public health challenge and affects a substantial number of children. Trauma impacts psychological and physical development, as well as long term mental and physical health and behaviour. These adverse outcomes can be prevented through appropriate treatment. Unfortunately, there is a substantial gap between the need for treatment and access to evidence-based care. Low-intensive treatments that utilize and strengthen family resources could contribute to bridging this gap and contribute to improving long-term public health and quality of life.

The Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT; Salloum et al. .2014) is a promising intervention for traumatized children that consists of two steps: 1) Stepping Together for Children after Trauma (Stepping Together CT, ST-CT), which is a parent-led, therapist-assisted treatment that takes advantage of and strengthens parent resources; and 2) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT; Cohen et al. 2017) which is a therapist-led treatment provided when Stepping Together CT does not sufficiently help the child. Results from a recent randomized control trial (RCT) conducted in the United States, show that SC-CBT-CT is as effective as standard therapist-led TF-CBT in reducing post-traumatic symptoms, depression, sleep disturbance and parental distress, while simultaneously reducing treatment-related costs by 50% (Salloum et al. 2022). In Norway, a recent pilot study found that the first step, ST-CT, is well accepted by children, parents, and therapists, and is feasible as a first-line intervention in the municipal services (ClinicalTrials.gov Identifier: NCT04073862).

The current study is an RCT with a hybrid effectiveness-implementation design where ST-CT will be implemented to municipal first-line service centers. Participants will be randomized to either the ST-CT or usual care (UC). We will recruit 160 child-parent dyads through 30 participating municipalities from 2023-2025. This will be the first RCT of ST-CT from an independent research group, with the potential for wider implementation which will greatly impact the resources and tools the municipalities have in facing challenges related to childhood trauma.

Aims and data collection:

  1. Assess the effectiveness of the parent-led intervention in reducing symptoms on post-traumatic stress, depression, somatic pain and quality of life from both children and caregivers compared to UC. In addition, an objective assessment of quality of sleep will be recorded with a sensor that registers the child's sleep patterns; 2) Evaluate the cost-effectiveness and cost-utility of the ST-CT model; 3) Assess the potential preventive effect of the intervention through long-term follow-up data on use of health services from the Norwegian Patient Registry (NPR), the Norwegian Prescribed Drug Registry (NorPD), and Statistics Norway (SSB); and 4) Investigate barriers and facilitator for implementation, develop culturally adapted treatment material, and an implementation guideline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The assessments will be conducted by a clinician from the study group that will be blind to treatment condition

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child is between 7-12 years
  • Exposed to a potentially traumatizing event according to the DSM-5 A-criterion
  • Has a minimum of 5 symptoms of post-traumatic stress (1 symptom must be re-experiencing or avoidance)
  • ≥3 years at the time of the traumatic event to ensure an explicit memory of the event
  • ≥1 month since the traumatic event, according to the diagnostic criteria for PTSD
  • The child must confirm in a conversation alone with the therapist that they feel safe at home and together with the parent and that they are not exposed to ongoing trauma.

排除标准

  • Suspicions of psychosis, active suicidality, serious intellectual disability, or lack of Norwegian skills to complete the workbook
  • A psychotropic medication regime that has not been stable for at least 4 weeks (2 weeks for stimulants/benzodiazepines)
  • Currently receives other trauma treatment.
  • Caregiver/family exclusion criteria for participation:
  • A caregiver that is the cause of the trauma exposure can neither be the caregiver that leads the treatment nor live in the same household as the child at the time of treatment
  • The caregiver has had a substance use disorder within the past 3 months, suspected suicidality or insufficient Norwegian language skills to complete the workbook/treatment without use of an interpreter.

结局指标

主要结局

Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

时间窗: 12 months follow-up (T5)

The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

次要结局

  • Kidscreen 27: Friends and School dimension(12 months follow-up (T5))
  • The Rage Outburst and Anger Rating Scale (ROARS)(12 months follow-up (T5))
  • Short Moods and Feeling Questionnaire (SMFQ)(12 months follow-up (T5))
  • Kidscreen 52 - The Parent Relations and Home Life dimension(Every 2 weeks between T1 and T2 (3 times))
  • Child Health Utility instrument (CHU9D)(12 months follow-up (T5))
  • The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)(Twice a week between T1 and T2 (at the at-home meetings, 15 assessments))
  • The Parent Child Communication Scale, child version (PCCSc)(12 months follow-up (T5))
  • Children's somatic symptoms inventory short form (CSSI-8)(12 months follow-up (T5))
  • Sleep Disturbance Scale for Children (SDSC)(12 months follow-up (T5))
  • Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)(12 months follow-up (T5))
  • Kidscreen 27: Friends and school dimensions(Baseline (T1))
  • Child sleep quality: objective measure and sleep diary(7 days post-treatment/ after 15 weeks)
  • Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report(12 months follow-up (T5))
  • The Child and Adolescent Serive Use Schedule (CA-SUS)(12 months follow-up (T5))

研究者

发起方
Norwegian Center for Violence and Traumatic Stress Studies
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silje Ormhaug

Principal Investigator

Norwegian Center for Violence and Traumatic Stress Studies

研究点 (2)

Loading locations...

相似试验