NCT05734547 Stepping Together for Children After Trauma, Norway
| NCT ID | NCT05734547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian Center for Violence and Traumatic Stress Studies |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-04-14 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2023-04-14 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Silje M Ormhaug
PRINCIPAL INVESTIGATOR
Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
Frequently Asked Questions
Who can join the NCT05734547 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05734547 currently recruiting?
Yes, NCT05734547 is actively recruiting participants. Contact the research team at s.m.ormhaug@nkvts.no for enrollment information.
Where is the NCT05734547 trial being conducted?
This trial is being conducted at Asker, Norway, Oslo, Norway.
Who is sponsoring the NCT05734547 clinical trial?
NCT05734547 is sponsored by Norwegian Center for Violence and Traumatic Stress Studies. The principal investigator is Silje M Ormhaug at Norwegian Center for Violence and Traumatic Stress Studies (NKVTS). The trial plans to enroll 160 participants.
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