Parent-led treatment for children with trauma symptoms
Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)
This study is testing a new parent-led treatment for children aged 7-12 with trauma symptoms to see if it helps them feel better compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Norwegian Center for Violence and Traumatic Stress Studies Academic / other |
| Locations | 2 sites (Asker and 1 other locations) |
| Trial ID | NCT05734547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-12 who have experienced a potentially traumatizing event and exhibit moderate symptoms of posttraumatic stress.
Not a fit: Patients with active psychosis, serious intellectual disabilities, or those currently receiving other trauma treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce trauma-related symptoms in children and improve their overall quality of life.
How similar studies have performed: Previous studies have shown success with similar parent-led interventions, indicating a promising approach to treating childhood trauma.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Asker and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.