Parent-led treatment for children with trauma symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to evaluate the effectiveness of a parent-led, therapist-assisted treatment called 'Stepping Together for Children after Trauma' (ST-CT) for children aged 7-12 who exhibit moderate posttraumatic stress symptoms after experiencing trauma. The study will compare ST-CT to usual care in terms of reducing symptoms of PTSD, depression, and sleep disorders, while also assessing improvements in daily functioning for both children and their parents. Participants will be randomly assigned to either the ST-CT intervention or standard care, with symptom assessments conducted at five different time points. The study also seeks to determine the cost-effectiveness of ST-CT when implemented in municipal first-line services.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asker kommune
  Asker, Norway Recruiting
• Nkvts
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Silje M Ormhaug — Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
• Study coordinator: Silje M Ormhaug, PhD
• Email: s.m.ormhaug@nkvts.no
• Phone: +4799609336

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.