RecruitingNot ApplicableNCT05734547

Stepping Together for Children After Trauma, Norway

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

Sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Enrollment

160 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Quality of Life Depressive Symptoms Sleep Disorder PTSD

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

Min Age: 7 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This Norwegian study tests a structured, family-based therapy program called 'Stepping Together' to help children aged 7 to 12 recover from post-traumatic stress disorder (PTSD) following a traumatic event. The program involves the child and their parent/caregiver working through the treatment together with a therapist. This is a randomised controlled trial comparing the program to standard care. **Your child may be eligible if...** - They are between 7 and 12 years old - They experienced a potentially traumatic event that meets clinical criteria - They have at least 5 post-traumatic stress symptoms (at least one must be reliving the event or avoiding reminders) - It has been at least 1 month since the traumatic event - They were 3 or older at the time of the trauma (so they can remember it) - They feel safe at home with their caregiver **Your child may NOT be eligible if...** - There are concerns about psychosis, active suicidal thoughts, severe intellectual disability, or lack of Norwegian language skills - They are currently receiving other trauma-specific treatment - The caregiver is the source of the trauma and lives in the household - The caregiver has had substance misuse problems in the past 3 months, or suspected suicidality Talk to your doctor to see if this trial is right for your child.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALStepping Together for Children after Trauma (ST-CT)

ST-CT is Step One of Stepped Care CBT for Children after Trauma (previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy; Salloum et al., 2014). It consists of five components: psychoeducation, stabilization, trauma narrative, in-vivo exposures and consolidation. The parent and child have 11 at-home-meetings and complete tasks in a workbook, Stepping Together (from the Preschool PTSD Treatment by Michael Scheeringa et al), over 6-9 weeks. In addition, there are weekly calls and five sessions with the therapist. Children who meet responder-criteria (i.e., no more than four symptoms of PTSS) continue to a 6-week maintenance phase, after which treatment is complete if the child still meets responder criteria. For those who do not meet responder-criteria, or are not able to complete the workbook, the responsibility for the treatment is transferred from the municipal service level to the corresponding child and adolescent mental health service (BUP).

BEHAVIORALUsual care

Therapists in the control group will provide the treatment they usually provide, and develop a treatment plan in collaboration with the parents. This may consist of individual sessions with the child, parent sessions, group treatment, meetings with the school and other collaborating services, or referral to the second line mental health centres (BUP).