Norwegian Center for Violence and Traumatic Stress Studies
Phase
Not applicable
Started
2023-04-14
Last updated
2024-11-18
Condition(s) studied
PTSDSleep DisorderDepressive SymptomsQuality of Life
Investigational drug(s) / intervention(s)
Stepping Together for Children after Trauma (ST-CT)Usual care
Stepping Together for Children after Trauma (ST-CT): ST-CT is Step One of Stepped Care CBT for Children after Trauma (previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy; Salloum et al., 2014). It consists of five components: psychoeducation, stabilization, trauma narrative, in-vivo exposures and consolidation. The parent and child have 11 at-home-meetings and complete tasks in a workbook, Stepping Together (from the Preschool PTSD Treatment by Michael Scheeringa et al), over 6-9 weeks. In addition, there are weekly calls and five sessions with the therapist. Children who meet responder-criteria (i.e., no more than four symptoms of PTSS) continue to a 6-week maintenance phase, after which treatment is complete if the child still meets responder criteria. For those who do not meet responder-criteria, or are not able to complete the workbook, the responsibility for the treatment is transferred from the municipal service level to the corresponding child and adolescent mental health service (BUP).
Usual care: Therapists in the control group will provide the treatment they usually provide, and develop a treatment plan in collaboration with the parents. This may consist of individual sessions with the child, parent sessions, group treatment, meetings with the school and other collaborating services, or referral to the second line mental health centres (BUP).
Study summary
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.
Eligibility
Sex
ALL
Min age
7 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
1. Child is between 7-12 years
2. Exposed to a potentially traumatizing event according to the DSM-5 A-criterion
3. Has a minimum of 5 symptoms of post-traumatic stress (1 symptom must be re-experiencing or avoidance)
4. ≥3 years at the time of the traumatic event to ensure an explicit memory of the event
5. ≥1 month since the traumatic event, according to the diagnostic criteria for PTSD
6. 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.
Exclusion Criteria:
1. Suspicions of psychosis, active suicidality, serious intellectual disability, or lack of Norwegian skills to complete the workbook
2. A psychotropic medication regime that has not been stable for at least 4 weeks (2 weeks for stimulants/benzodiazepines)
3. Currently receives other trauma treatment.
Caregiver/family exclusion criteria for participation:
1. 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
2. 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.
Primary outcome measure(s)
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) — Baseline (T1) 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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) — Mid-treatment/ 9 weeks (T2) 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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) — Post-treatment/ 15 weeks (T3) 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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) — 6 months follow-up (T4) 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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) — 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.
Trial sites (2)
Facility
City
Region
Status
Asker kommune
Asker
Norway
Recruiting
NKVTS
Oslo
Norway
Recruiting
More Norwegian Center for Violence and Traumatic Stress Studies trials in Norway
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