Stepping Together for Children After Trauma, Norway

NCT ID: NCT05734547

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-14
• Study Completion Date: 2028-12-01

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.

Detailed Description

Childhood trauma is a major public health challenge and affects a substantial number of children. Trauma impacts psychological and physical development, as well as long term mental and physical health and behaviour. These adverse outcomes can be prevented through appropriate treatment. Unfortunately, there is a substantial gap between the need for treatment and access to evidence-based care. Low-intensive treatments that utilize and strengthen family resources could contribute to bridging this gap and contribute to improving long-term public health and quality of life.

The Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT; Salloum et al. .2014) is a promising intervention for traumatized children that consists of two steps: 1) Stepping Together for Children after Trauma (Stepping Together CT, ST-CT), which is a parent-led, therapist-assisted treatment that takes advantage of and strengthens parent resources; and 2) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT; Cohen et al. 2017) which is a therapist-led treatment provided when Stepping Together CT does not sufficiently help the child. Results from a recent randomized control trial (RCT) conducted in the United States, show that SC-CBT-CT is as effective as standard therapist-led TF-CBT in reducing post-traumatic symptoms, depression, sleep disturbance and parental distress, while simultaneously reducing treatment-related costs by 50% (Salloum et al. 2022). In Norway, a recent pilot study found that the first step, ST-CT, is well accepted by children, parents, and therapists, and is feasible as a first-line intervention in the municipal services (ClinicalTrials.gov Identifier: NCT04073862).

The current study is an RCT with a hybrid effectiveness-implementation design where ST-CT will be implemented to municipal first-line service centers. Participants will be randomized to either the ST-CT or usual care (UC). We will recruit 160 child-parent dyads through 30 participating municipalities from 2023-2025. This will be the first RCT of ST-CT from an independent research group, with the potential for wider implementation which will greatly impact the resources and tools the municipalities have in facing challenges related to childhood trauma.

Aims and data collection:

1) Assess the effectiveness of the parent-led intervention in reducing symptoms on post-traumatic stress, depression, somatic pain and quality of life from both children and caregivers compared to UC. In addition, an objective assessment of quality of sleep will be recorded with a sensor that registers the child's sleep patterns; 2) Evaluate the cost-effectiveness and cost-utility of the ST-CT model; 3) Assess the potential preventive effect of the intervention through long-term follow-up data on use of health services from the Norwegian Patient Registry (NPR), the Norwegian Prescribed Drug Registry (NorPD), and Statistics Norway (SSB); and 4) Investigate barriers and facilitator for implementation, develop culturally adapted treatment material, and an implementation guideline.

Assessments of the children and parents will be conducted by an independent assessor at five time points: T1 = baseline, T2 = after completion of the workbook (ST-CT)/9 weeks (UC); T3 = after the maintenance phase (ST-CT)/ 15 weeks (UC); T4 = 6 months after baseline; T5 = 12 months after baseline.

A secondary aim is to investigate the change-processes within the ST-CT arm, including when during the treatment change in PTSS occurs and how change is related to parenting practices and the child's perceived relationship to their parent.

Assessments related to change-processes will take place in the first 6-9 weeks of treatment, between T1 and T2, for participants in the ST-CT arm only. Specifically, we will collect a short post-traumatic stress symptom assessment (at each parent-child meeting at home, and the first four sessions with the therapist, altogether 15 times), and assess parenting practices and the child's perceived relationship to the parent (the first four sessions with the therapist).

Conditions

PTSD; Sleep Disorder; Depressive Symptoms; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stepping Together for Children after Trauma (ST-CT)

Parent-led, therapist assisted CBT treatment

Group Type: EXPERIMENTAL

Stepping Together for Children after Trauma (ST-CT)

Intervention Type: 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).

Usual care

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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).

Interventions

Stepping 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).

Intervention Type: BEHAVIORAL

Usual 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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Part of the treatment previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy

Eligibility 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.

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Care Services, Norway

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

Norwegian Center for Violence and Traumatic Stress Studies

OTHER

Sponsor Role: lead

Responsible Party

Silje Ormhaug

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silje M Ormhaug

Role: PRINCIPAL_INVESTIGATOR

Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)

Locations

Asker kommune

Asker, , Norway

Site Status: RECRUITING

NKVTS

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Silje M Ormhaug, PhD

Role: CONTACT

s.m.ormhaug@nkvts.no

+4799609336

Ingeborg Skjærvø, PhD

Role: CONTACT

ingeborg.skjarvo@nkvts.no

Facility Contacts

Trude Hansen

Role: primary

Kristin Eliassen, MA

Role: primary

krel@nkvts.no

Silje Ormhaug, PhD

Role: backup

trinnvissammen@nkvts.no

References

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.

Reference Type: BACKGROUND

PMID: 35032578 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25411544 (View on PubMed)

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 40958761 (View on PubMed)

Other Identifiers

The NorStep Study

Identifier Type: -

Identifier Source: org_study_id