Stepping Together for Children After Trauma, Norway

NCT05734547 | Recruiting

• 1 other identifier: The NorStep Study
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PTSD; Sleep Disorder; Depressive Symptoms; Quality of Life

Keywords

Posttraumatic stress symptoms; Parent-led treatment; Cost-effectiveness; Childhood trauma

Outcome Measures

Primary Outcomes (5)

• Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

  The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

  Baseline (T1)

• Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

  The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

  Mid-treatment/ 9 weeks (T2)

• Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

  The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

  Post-treatment/ 15 weeks (T3)

• Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

  The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

  6 months follow-up (T4)

• Child and Adolescent Trauma Screen 2.0 (CATS 2.0)

  The CATS 2.0 assesses child PTSD in the last 4 weeks, according to the DSM-5 and ICD-11 manuals. It includes 15 items of trauma exposure; 20 symptoms of PTS and complex-PTS (intrusions/re-experiencing, avoidance, negative changes in cognition/mood, hyperarousal, and disturbances in self-organization), and 5 items assessing the symptoms' interference on psychosocial functioning. Symptom scores range from 0-60 with higher scores indicating higher levels of PTSD symptoms.

  12 months follow-up (T5)

Secondary Outcomes (59)

• Short Moods and Feeling Questionnaire (SMFQ)

  Baseline (T1)

• Short Moods and Feeling Questionnaire (SMFQ)

  Mid-treatment/ 9 weeks (T2)

• Short Moods and Feeling Questionnaire (SMFQ)

  Post-treatment/ 15 weeks (T3)

• Short Moods and Feeling Questionnaire (SMFQ)

  6 months follow-up (T4)

• Short Moods and Feeling Questionnaire (SMFQ)

  12 months follow-up (T5)

Other Outcomes (37)

• Stressful Life-Events Screening Questionnaire (SLESQ)

  Baseline (T1)

• Stressful Life-Events Screening Questionnaire (SLESQ)

  Mid-treatment/ 9 weeks (T2)

• Stressful Life-Events Screening Questionnaire (SLESQ)

  Post-treatment/ 15 weeks (T3)

Study Arms (2)

Stepping Together for Children after Trauma (ST-CT)

EXPERIMENTAL

Parent-led, therapist assisted CBT treatment

Behavioral: Stepping Together for Children after Trauma (ST-CT)

Usual care

ACTIVE COMPARATOR

The types of interventions normally provided in the first-line municipal services

Behavioral: Usual care

Interventions

Stepping Together for Children after Trauma (ST-CT) BEHAVIORAL

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).

Also known as: Part of the treatment previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy

Stepping Together for Children after Trauma (ST-CT)

Usual care BEHAVIORAL

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).

Usual care

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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
• 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies: lead
• Ministry of Health and Care Services, Norway: collaborator
• University of Oslo: collaborator
• King's College London: collaborator

Study Sites (2)

Asker kommune

Asker, Norway

RECRUITING

NKVTS

Oslo, Norway

RECRUITING

Related Publications (4)

• Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.

  PMID: 35032578 BACKGROUND

• Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.

  PMID: 25411544 BACKGROUND

• Cohen JA, Mannarino AP, Deblinger E. Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017

  BACKGROUND

• Ormhaug SM, Jensen TK, Porcheret KL, Andreassen AL, Byford S, Fagermoen EMK, Gurandsrud P, Haabrekke KJO, Lindebo Knutsen M, Paivarinne HM, Skjaervo I. Stepping together for children after trauma: protocol for a randomized controlled trial of a parent-led treatment in first-line services (NorStep Study). Eur J Psychotraumatol. 2025 Dec;16(1):2555047. doi: 10.1080/20008066.2025.2555047. Epub 2025 Sep 17.

  PMID: 40958761 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Wake Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Silje M Ormhaug

  Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silje M Ormhaug, PhD

CONTACT

+4799609336; s.m.ormhaug@nkvts.no

Ingeborg Skjærvø, PhD

CONTACT

ingeborg.skjarvo@nkvts.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessments will be conducted by a clinician from the study group that will be blind to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 21, 2023
• Study Start: April 14, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2026-2032
• Access Criteria: Receiving party must follow the general data protection pegulation (GDPR).

Locations

NO (2)