Clinical trial NCT05734547: Stepping Together for Children After Trauma, Norway
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Sleep Disorder
Depressive Symptoms
Quality of Life
Keywords: Posttraumatic stress symptoms
Parent-led treatment
Cost-effectiveness
Childhood trauma
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Care Services, Norway
name: University of Oslo
name: King's College London
First posted: 2023-02-21
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: Baseline (T1)
measure: Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: 6 months follow-up (T4)
measure: Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: 12 months follow-up (T5)
Secondary outcomes:
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: Baseline (T1)
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: 6 months follow-up (T4)
measure: Short Moods and Feeling Questionnaire (SMFQ)
timeFrame: 12 months follow-up (T5)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: Baseline (T1)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: 6 months follow-up (T4)
measure: Sleep Disturbance Scale for Children (SDSC)
timeFrame: 12 months follow-up (T5)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: Baseline (T1)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: 6 months follow-up (T4)
measure: Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)
timeFrame: 12 months follow-up (T5)
measure: The Parent Child Communication Scale, child version (PCCSc)
timeFrame: Baseline (T1)
measure: The Parent Child Communication Scale, child version (PCCSc)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: The Parent Child Communication Scale, child version (PCCSc)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: The Parent Child Communication Scale, child version (PCCSc)
timeFrame: 6 months follow-up (T4)
measure: The Parent Child Communication Scale, child version (PCCSc)
timeFrame: 12 months follow-up (T5)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: Baseline (T1)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: 6 months follow-up (T4)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: 12 months follow-up (T5)
measure: Kidscreen 52 - The Parent Relations and Home Life dimension
timeFrame: Every 2 weeks between T1 and T2 (3 times)
measure: Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
timeFrame: Baseline (T1)
measure: Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
timeFrame: 6 months follow-up (T4)
measure: Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report
timeFrame: 12 months follow-up (T5)
measure: Child Health Utility instrument (CHU9D)
timeFrame: Baseline (T1)
measure: Child Health Utility instrument (CHU9D)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Child Health Utility instrument (CHU9D)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Child Health Utility instrument (CHU9D)
timeFrame: 6 months follow-up (T4)
measure: Child Health Utility instrument (CHU9D)
timeFrame: 12 months follow-up (T5)
measure: Kidscreen 27: Friends and school dimensions
timeFrame: Baseline (T1)
measure: Kidscreen 27: Friends and School dimension
timeFrame: Mid-treatment/9 weeks (T2)
measure: Kidscreen 27: Friends and School dimension
timeFrame: Post-treatment/15 weeks (T3)
measure: Kidscreen 27: Friends and School dimension
timeFrame: 6 months follow-up (T4)
measure: Kidscreen 27: Friends and School dimension
timeFrame: 12 months follow-up (T5)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: Baseline (T1)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: 6 months follow-up (T4)
measure: Children's somatic symptoms inventory short form (CSSI-8)
timeFrame: 12 months follow-up (T5)
measure: Child sleep quality: objective measure and sleep diary
timeFrame: 7 days before treatment starts
measure: Child sleep quality: objective measure and sleep diary
timeFrame: 7 days post-treatment/ after 15 weeks
measure: The Rage Outburst and Anger Rating Scale (ROARS)
timeFrame: Baseline (T1)
measure: The Rage Outburst and Anger Rating Scale (ROARS)
timeFrame: Mid-treatment/9 weeks (T2)
measure: The Rage Outburst and Anger Rating Scale (ROARS)
timeFrame: Post-treatment/15 weeks (T3)
measure: The Rage Outburst and Anger Rating Scale (ROARS)
timeFrame: 6 months follow-up (T4)
measure: The Rage Outburst and Anger Rating Scale (ROARS)
timeFrame: 12 months follow-up (T5)
measure: The Child and Adolescent Serive Use Schedule (CA-SUS)
timeFrame: Baseline (T1)
measure: The Child and Adolescent Serive Use Schedule (CA-SUS)
timeFrame: Mid-treatment/9 weeks (T2)
measure: The Child and Adolescent Serive Use Schedule (CA-SUS)
timeFrame: Post-treatment/15 weeks (T3)
measure: The Child and Adolescent Serive Use Schedule (CA-SUS)
timeFrame: 6 months follow-up (T4)
measure: The Child and Adolescent Serive Use Schedule (CA-SUS)
timeFrame: 12 months follow-up (T5)
measure: The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)
timeFrame: Twice a week between T1 and T2 (at the at-home meetings, 15 assessments)
Other outcomes:
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: Baseline (T1)
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: 6 months follow-up (T4)
measure: Stressful Life-Events Screening Questionnaire (SLESQ)
timeFrame: 12 months follow-up (T5)
measure: International Trauma Questionnaire (ITQ)
timeFrame: Baseline (T1)
measure: International Trauma Questionnaire (ITQ)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: International Trauma Questionnaire (ITQ)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: International Trauma Questionnaire (ITQ)
timeFrame: 6 months follow-up (T4)
measure: International Trauma Questionnaire (ITQ)
timeFrame: 12 months follow-up (T5)
measure: Hopkins Symptom Check List 25 (HSCL-25)
timeFrame: Baseline (T1)
measure: Hopkins Symptom Check List 25 (HSCL-25)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Hopkins Symptom Check List 25 (HSCL-25)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Hopkins Symptom Check List 25 (HSCL-25)
timeFrame: 6 months follow-up (T4)
measure: Hopkins Symptom Check List 25 (HSCL-25)
timeFrame: 12 months follow-up (T5)
measure: Parents Emotional Reactions Questionnaire (PERQ)
timeFrame: Baseline (T1)
measure: Parents Emotional Reactions Questionnaire (PERQ)
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Parents Emotional Reactions Questionnaire (PERQ)
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Parents Emotional Reactions Questionnaire (PERQ)
timeFrame: 6 months follow-up (T4)
measure: Parents Emotional Reactions Questionnaire (PERQ)
timeFrame: 12 months follow-up (T5)
measure: Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
timeFrame: Baseline (T1)
measure: Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
timeFrame: Mid-treatment/ 9 weeks (T2)
measure: Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
timeFrame: Post-treatment/ 15 weeks (T3)
measure: Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
timeFrame: 6 months follow-up (T4)
measure: Parent Trauma Response Questionnaire (PTRQ), Child coping dimension
timeFrame: 12 months follow-up (T5)
measure: Implementation Leadership Scale (ILS)
timeFrame: Before training
measure: Implementation Leadership Scale (ILS)
timeFrame: 4 months after training
measure: Implementation Leadership Scale (ILS)
timeFrame: 8 months after training
measure: Implementation Leadership Scale (ILS)
timeFrame: 12 months after training
measure: Professional Quality of Life Scale (ProQOL-V)
timeFrame: Before training
measure: Professional Quality of Life Scale (ProQOL-V)
timeFrame: 4 months after training
measure: Professional Quality of Life Scale (ProQOL-V)
timeFrame: 8 months after training
measure: Professional Quality of Life Scale (ProQOL-V)
timeFrame: 12 months after training
measure: Turnover Intention Scale (TIS)
timeFrame: Before training
measure: Turnover Intention Scale (TIS)
timeFrame: 4 months after training
measure: Turnover Intention Scale (TIS)
timeFrame: 8 months after training
measure: Turnover Intention Scale (TIS)
timeFrame: 12 months after training
Locations:
city: Asker
country: Norway
facility: Asker kommune
city: Oslo
country: Norway
facility: NKVTS
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies (NKVTS)
name: Silje M Ormhaug
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Cohen JA, Mannarino AP, Deblinger E. Treating Trauma and Traumatic Grief in Children and Adolescents. 2nd ed. New York: Guilford Press; 2017