Stepping Together for Children After Trauma, Norway

Not Applicable

Recruiting

• Conditions: Sleep Disorder; Depressive Symptoms; PTSD; Quality of Life
• Interventions: Behavioral: Stepping Together for Children after Trauma (ST-CT); Behavioral: Usual care

• Registration Number: NCT05734547
• Lead Sponsor: Norwegian Center for Violence and Traumatic Stress Studies

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).

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-21
• Study Start: 2023-04-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepping Together for Children after Trauma (ST-CT)	Stepping Together for Children after Trauma (ST-CT)	Parent-led, therapist assisted CBT treatment
Usual care	Usual care	The types of interventions normally provided in the first-line municipal services

Primary Outcome Measures

Name	Time	Method
Child and Adolescent Trauma Screen 2.0 (CATS 2.0)	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.

Secondary Outcome Measures

Name	Time	Method
Kidscreen 27: Friends and School dimension	12 months follow-up (T5)	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.
The Rage Outburst and Anger Rating Scale (ROARS)	12 months follow-up (T5)	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.
Short Moods and Feeling Questionnaire (SMFQ)	12 months follow-up (T5)	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.
Kidscreen 52 - The Parent Relations and Home Life dimension	Every 2 weeks between T1 and T2 (3 times)	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).
Child Health Utility instrument (CHU9D)	12 months follow-up (T5)	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.
The ICD-11 criteria of the Child and Adolescent Trauma Screen 2.0 (CATS 2.0)	Twice a week between T1 and T2 (at the at-home meetings, 15 assessments)	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).
The Parent Child Communication Scale, child version (PCCSc)	12 months follow-up (T5)	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.
Children's somatic symptoms inventory short form (CSSI-8)	12 months follow-up (T5)	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.
Sleep Disturbance Scale for Children (SDSC)	12 months follow-up (T5)	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.
Children's Post-Traumatic Cognitions Inventory Short (CPTCI-S)	12 months follow-up (T5)	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.
Kidscreen 27: Friends and school dimensions	Baseline (T1)	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.
Child sleep quality: objective measure and sleep diary	7 days post-treatment/ after 15 weeks	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.
Strengths and Difficulties Questionnaire (SDQ) - Parent and Teacher report	12 months follow-up (T5)	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.
The Child and Adolescent Serive Use Schedule (CA-SUS)	12 months follow-up (T5)	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.

Trial Locations

Locations (2)

Asker kommune; 🇳🇴 Asker, Norway

NKVTS; 🇳🇴 Oslo, Norway