PTSDNorStepNCT05734547
Stepping Together for Children After Trauma, Norway
A study testing Stepping Together for Children after Trauma (ST-CT) in people with PTSD and Sleep Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- PTSD, Sleep Disorder, Depressive Symptoms
- What is being tested?
- Stepping Together for Children after Trauma (ST-CT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- 14 Apr 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Caregiver/family exclusion criteria for participation:
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ingeborg Skjærvø, PhD contact
Norway2 sites, 2 recruiting
- Recruiting
Asker kommune
Asker
Trude Hansen
- Recruiting
NKVTS
Oslo
Kristin Eliassen, MA, krel@nkvts.no
Silje Ormhaug, PhD, trinnvissammen@nkvts.no
About this study
Official title: Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)
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.
Read the 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:
- 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
- Being tested
- Stepping Together for Children after Trauma (ST-CT), Usual care
- Keywords
- Posttraumatic stress symptoms, Parent-led treatment, Cost-effectiveness, Childhood trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepping Together for Children after Trauma (ST-CT)Behavioural
Also called Part of the treatment previously called Stepped Care Trauma-focused Cognitive Behavioral Therapy
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 careBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Stepping Together for Children after Trauma (ST-CT) | Experimental | Parent-led, therapist assisted CBT treatment Receives: 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 Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months follow-up (T5)
Secondary outcomes (59)
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Measured: Baseline (T1)
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Measured: Mid-treatment/ 9 weeks (T2)
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Measured: Post-treatment/ 15 weeks (T3)
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Measured: 6 months follow-up (T4)
Short Moods and Feeling Questionnaire (SMFQ)
The measure has 13 items assessing symptoms of depression during the last 2 weeks. Scores range from 0-26 with higher scores indicating greater depressive symptoms.
Measured: 12 months follow-up (T5)
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Measured: Baseline (T1)
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Measured: Mid-treatment/ 9 weeks (T2)
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Measured: Post-treatment/ 15 weeks (T3)
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Measured: 6 months follow-up (T4)
Sleep Disturbance Scale for Children (SDSC)
The scale includes 26 items that covers 6 types of sleep disorders. It is completed by the child's caregiver, and scores range from 26-130, with a higher score indicating more sleep disturbance.
Measured: 12 months follow-up (T5)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Measured: Baseline (T1)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Measured: Mid-treatment/ 9 weeks (T2)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Measured: Post-treatment/ 15 weeks (T3)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Measured: 6 months follow-up (T4)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
The scale includes 10 items covering the two components "Disturbing and permanent change" and "Feeble person in a scary world". Scores range from 10-40, with higher scores indicating greater post-traumatic cognitions.
Measured: 12 months follow-up (T5)
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Measured: Baseline (T1)
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Measured: Mid-treatment/ 9 weeks (T2)
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Measured: Post-treatment/ 15 weeks (T3)
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Measured: 6 months follow-up (T4)
The Parent Child Communication Scale, child version (PCCSc)
10 items covering the child's perception of their communication with their parents. Scores range from 0-40, with higher scores indicating better communication with the parent.
Measured: 12 months follow-up (T5)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Measured: Baseline (T1)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Measured: Mid-treatment/ 9 weeks (T2)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Measured: Post-treatment/ 15 weeks (T3)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Measured: 6 months follow-up (T4)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life.
Measured: 12 months follow-up (T5)
Kidscreen 52 - The Parent Relations and Home Life dimension
The scale has 6 items covering the child's perceptions of being loved, understood, and being able to talk to their parents, during the last week. Scores range from 6-30, with higher scores indicating better relationships and home-life. For the children in the ST-CT arm only, we include these additional measuring points of Parent Relations to be able to explore change-processed during treatment with ST-CT (assessment at the first four sessions with the therapist).
Measured: Every 2 weeks between T1 and T2 (3 times)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Measured: Baseline (T1)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Measured: Mid-treatment/ 9 weeks (T2)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Measured: Post-treatment/ 15 weeks (T3)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Measured: 6 months follow-up (T4)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
The SDQ includes 25 items covering five areas of clinical interest: hyperactivity/inattention, emotional symptoms, conduct problems, peer relation problems, and prosocial behaviors. The four first areas (20 items) can be summed to give an overall picture of difficulties, with scores ranging from 0-40, or kept as two subscales (internalizing and externalizing) of 10 items each. Higher scores indicate more difficulties. The fifth area, prosocial behavior, is kept as a separate scale from 0-10 where a higher score indicates more prosocial behaviors/strengths.
Measured: 12 months follow-up (T5)
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Measured: Baseline (T1)
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Measured: Mid-treatment/ 9 weeks (T2)
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Measured: Post-treatment/ 15 weeks (T3)
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Measured: 6 months follow-up (T4)
Child Health Utility instrument (CHU9D)
The CHU9D is a measure of health-related quality of life (HRQoL). The scale covers 9 dimensions such as feeling worried, tired, annoyed, and not being able to complete school-work, daily activities and chores. Each dimension has 5 response levels, and higher scores indicate lower HRQoL.
Measured: 12 months follow-up (T5)
Kidscreen 27: Friends and school dimensions
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Measured: Baseline (T1)
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Measured: Mid-treatment/9 weeks (T2)
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Measured: Post-treatment/15 weeks (T3)
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Measured: 6 months follow-up (T4)
Kidscreen 27: Friends and School dimension
The scales consists of 4 questions regarding the child's relationship to their friends, and 4 items regarding school functioning during the last week. Items are scored on a 5-point scale, ranging from 4-20 for each subscale. Higher scores indicate better functioning.
Measured: 12 months follow-up (T5)
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Measured: Baseline (T1)
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Measured: Mid-treatment/ 9 weeks (T2)
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Measured: Post-treatment/ 15 weeks (T3)
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Measured: 6 months follow-up (T4)
Children's somatic symptoms inventory short form (CSSI-8)
The scale consists of 8 items covering pain and somatic symptoms during the last 2 weeks. Scores range from 0-32 with higher scores indicating more somatic symptoms.
Measured: 12 months follow-up (T5)
Child sleep quality: objective measure and sleep diary
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
Measured: 7 days before treatment starts
Child sleep quality: objective measure and sleep diary
A non-contact sensor (Somnofy radar, Vital Things A/S) will be used to assess the child's sleep quality in 7 days before treatment start. The sensor registers the child's movement, respiration frequency and sleep quality during the night. A sleep diary will be completed for the same 7 days, with parents recording: when their child falls asleep, wakes up, time taken to fall asleep, awake periods during the night and how well they slept; and the child reporting: if they woke up at time, how many times and how well they slept.
Measured: 7 days post-treatment/ after 15 weeks
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Measured: Baseline (T1)
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Measured: Mid-treatment/9 weeks (T2)
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Measured: Post-treatment/15 weeks (T3)
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Measured: 6 months follow-up (T4)
The Rage Outburst and Anger Rating Scale (ROARS)
3 items where the parent rates the frequency, intensity and duration of the child's anger outbursts in the last 7 days. Each item is scored on a 4-point scale, and the sum score ranges from 0 to 9, with a higher score indicating more severe anger outbursts.
Measured: 12 months follow-up (T5)
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years.
At baseline, service use in the last 6 months will be recorded.
Measured: Baseline (T1)
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years.
At T2, service use in the period since T1 will be recorded.
Measured: Mid-treatment/9 weeks (T2)
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years.
At T3, service use in the period since T2 will be recorded.
Measured: Post-treatment/15 weeks (T3)
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years.
At T4, service use in the period since T3 will be recorded.
Measured: 6 months follow-up (T4)
The Child and Adolescent Serive Use Schedule (CA-SUS)
The parents report the total amount of health and social care services the child has received, including type of services and quantity, and the parents' days of absence from work. The type of services, quantity and parents' work-absence will be transformed to reflect costs related to services used, using cost units from the corresponding financial years.
At T5, service use in the period since T4 will be recorded.
Measured: 12 months follow-up (T5)
The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
We will use the 9 items that are prerequisites for assessing both an ICD-11 PTSD diagnosis (complex and non-complex) and and DSM-5 diagnosis, in the CATS 2.0 to assess change processes for the children in the ST-CT arm only. This will be assessed up to 15 times in the period between T1 and T2 (at 11 home parent-child meetings and 4 therapist sessions).
Measured: Twice a week between T1 and T2 (at the at-home meetings, 15 assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start14 Apr 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Care Services, Norway, University of Oslo, King's College London
- Responsible party
- Principal investigator, Silje Ormhaug, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Silje M Ormhaug, Principal investigator, Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734547
- Sponsor's protocol ID
- The NorStep Study
- Acronym
- NorStep
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-coded individual participant data will be made available after data inclusion upon participants' written consent.
Publications
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.
PubMed 35032578Salloum 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.
PubMed 25411544Cohen JA, Mannarino AP, Deblinger E. Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017
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.
PubMed 40958761
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepping Together for Children After Trauma: Investigating Effectiveness of a Parent-led, Therapist Assisted Trauma Treatment in Norwegian Municipal Services (The NorStep Study)
- ClinicalTrials.gov ID
- NCT05734547
- Acronym / sponsor ID
- NorStep / The NorStep Study
- Conditions
- PTSD, Sleep Disorder, Depressive Symptoms, Quality of Life
- Keywords
- Posttraumatic stress symptoms, Parent-led treatment, Cost-effectiveness, Childhood trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Collaborators
- Ministry of Health and Care Services, Norway, University of Oslo, King's College London
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepping Together for Children after Trauma (ST-CT) | Experimental | Behavioral: Stepping Together for Children after Trauma (ST-CT)Parent-led, therapist assisted CBT treatment |
| Usual care | Active comparator | Behavioral: Usual careThe types of interventions normally provided in the first-line municipal services |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepping Together for Children after Trauma (ST-CT)Also: Part of the treatment previously called Stepped Care Trauma-focused Cognitive Behavioral TherapyST-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). | Behavioural | Stepping Together for Children after Trauma (ST-CT) |
| Usual careTherapists 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). | Behavioural | Usual care |
Primary outcome
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Time frame: Baseline (T1)
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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Time frame: Mid-treatment/ 9 weeks (T2)
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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Time frame: Post-treatment/ 15 weeks (T3)
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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Time frame: 6 months follow-up (T4)
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.
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
Time frame: 12 months follow-up (T5)
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.
59 secondary outcomes
Short Moods and Feeling Questionnaire (SMFQ)
Time frame: Baseline (T1)
Short Moods and Feeling Questionnaire (SMFQ)
Time frame: Mid-treatment/ 9 weeks (T2)
Short Moods and Feeling Questionnaire (SMFQ)
Time frame: Post-treatment/ 15 weeks (T3)
Short Moods and Feeling Questionnaire (SMFQ)
Time frame: 6 months follow-up (T4)
Short Moods and Feeling Questionnaire (SMFQ)
Time frame: 12 months follow-up (T5)
Sleep Disturbance Scale for Children (SDSC)
Time frame: Baseline (T1)
Sleep Disturbance Scale for Children (SDSC)
Time frame: Mid-treatment/ 9 weeks (T2)
Sleep Disturbance Scale for Children (SDSC)
Time frame: Post-treatment/ 15 weeks (T3)
Sleep Disturbance Scale for Children (SDSC)
Time frame: 6 months follow-up (T4)
Sleep Disturbance Scale for Children (SDSC)
Time frame: 12 months follow-up (T5)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Time frame: Baseline (T1)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Time frame: Mid-treatment/ 9 weeks (T2)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Time frame: Post-treatment/ 15 weeks (T3)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Time frame: 6 months follow-up (T4)
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
Time frame: 12 months follow-up (T5)
The Parent Child Communication Scale, child version (PCCSc)
Time frame: Baseline (T1)
The Parent Child Communication Scale, child version (PCCSc)
Time frame: Mid-treatment/ 9 weeks (T2)
The Parent Child Communication Scale, child version (PCCSc)
Time frame: Post-treatment/ 15 weeks (T3)
The Parent Child Communication Scale, child version (PCCSc)
Time frame: 6 months follow-up (T4)
The Parent Child Communication Scale, child version (PCCSc)
Time frame: 12 months follow-up (T5)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: Baseline (T1)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: Mid-treatment/ 9 weeks (T2)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: Post-treatment/ 15 weeks (T3)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: 6 months follow-up (T4)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: 12 months follow-up (T5)
Kidscreen 52 - The Parent Relations and Home Life dimension
Time frame: Every 2 weeks between T1 and T2 (3 times)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Time frame: Baseline (T1)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Time frame: Mid-treatment/ 9 weeks (T2)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Time frame: Post-treatment/ 15 weeks (T3)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Time frame: 6 months follow-up (T4)
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
Time frame: 12 months follow-up (T5)
Child Health Utility instrument (CHU9D)
Time frame: Baseline (T1)
Child Health Utility instrument (CHU9D)
Time frame: Mid-treatment/ 9 weeks (T2)
Child Health Utility instrument (CHU9D)
Time frame: Post-treatment/ 15 weeks (T3)
Child Health Utility instrument (CHU9D)
Time frame: 6 months follow-up (T4)
Child Health Utility instrument (CHU9D)
Time frame: 12 months follow-up (T5)
Kidscreen 27: Friends and school dimensions
Time frame: Baseline (T1)
Kidscreen 27: Friends and School dimension
Time frame: Mid-treatment/9 weeks (T2)
Kidscreen 27: Friends and School dimension
Time frame: Post-treatment/15 weeks (T3)
Kidscreen 27: Friends and School dimension
Time frame: 6 months follow-up (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 35032578Salloum 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.
- Background: PubMed 25411544Salloum 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.
- BackgroundCohen JA, Mannarino AP, Deblinger E. Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017
- Derived from this study: PubMed 40958761Ormhaug 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.
- Individual participant dataSharing planned: Yes. De-coded individual participant data will be made available after data inclusion upon participants' written consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingeborg Skjærvø, PhD contact
Silje M Ormhaug principal investigator
Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepping Together for Children after Trauma (ST-CT) in people with PTSD and Sleep Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silje M Ormhaug, PhD (+4799609336, s.m.ormhaug@nkvts.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Trauma Screen 2.0 (CATS 2.0) (time frame: Baseline (T1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734547, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.