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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Asker kommune
RECRUITING
Asker
NKVTS
RECRUITING
Oslo
Contact Information
Primary
Silje M Ormhaug, PhD
s.m.ormhaug@nkvts.no
+4799609336
Backup
Ingeborg Skjærvø, PhD
ingeborg.skjarvo@nkvts.no
Time Frame
Start Date: 2023-04-14
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 160
Treatments
Experimental: Stepping Together for Children after Trauma (ST-CT)
Parent-led, therapist assisted CBT treatment
Active_comparator: Usual care
The types of interventions normally provided in the first-line municipal services
Related Therapeutic Areas
Sponsors
Leads: Norwegian Center for Violence and Traumatic Stress Studies
Collaborators: University of Oslo, Ministry of Health and Care Services, Norway, King's College London

This content was sourced from clinicaltrials.gov

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