BridgeMD
New treatment option for PTSD
Official title Stepping Together for Children After Trauma, Norway
ClinicalTrials.gov ID: NCT05734547
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 12
You may be able to join if
- 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
You likely can't join if
- 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...
- The caregiver has had a substance use disorder within the past 3 months, suspected suicidality or insufficient Norwegian language skills to complete...
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Asker, Norway
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asker, Norway; Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.