Actively Recruiting

Phase Not Applicable
Age: 7Years - 12Years
All Genders
NCT05734547

Stepping Together for Children After Trauma, Norway

Led by Norwegian Center for Violence and Traumatic Stress Studies · Updated on 2024-11-18

160

Participants Needed

2

Research Sites

294 weeks

Total Duration

On this page

Sponsors

N

Norwegian Center for Violence and Traumatic Stress Studies

Lead Sponsor

M

Ministry of Health and Care Services, Norway

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Stepping Together for Children After Trauma, Norway

Who Can Participate

Age: 7Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Asker kommune

Asker, Norway

Actively Recruiting

2

NKVTS

Oslo, Norway

Actively Recruiting

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Research Team

S

Silje M Ormhaug, PhD

CONTACT

I

Ingeborg Skjærvø, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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