TraumaNCT05226481
Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth
An observational study of Trauma and Mental Health Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
Trial summary
Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based practice (EBP) for the treatment of posttraumatic stress disorder (PTSD) and posttraumatic stress symptoms (PTSS) among children and adolescents. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Trauma, Mental Health Disorder, PTSD
- What is being tested?
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- How many people
- 216 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 21 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- Child, Adult
Study population: Routine trauma and PTSS screening among children and adolescents (aged 6-18 years) referred to CAMHS.
Who may be able to join
- Referred to Norwegian CAMHS
- Screened for trauma exposure and PTSS
Who cannot join
- Below the age of 6 and above the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based practice (EBP) for the treatment of posttraumatic stress disorder (PTSD) and posttraumatic stress symptoms (PTSS) among children and adolescents. In the current study, data were collected from youth receiving TF-CBT in specialized child and adolescent mental health services (CAMHS) and their caregivers in 2018-2021.
Read the detailed description
Implementation of TF-CBT is a state-wide initiative, funded by the Norwegian Ministry of Health and Care Services, and is without costs for the clinics and patients. The Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the project. TF-CBT trainers at NKVTS train therapists at the participating CAMHS in TF-CBT. Data are collected to monitor the training and patient outcomes. Data are collected anonymously to support and ensure high-quality treatment and also provide the opportunity to investigate the effect of the implementation of TF-CBT in Norwegian CAMHS. In the period 2018-2021, additional data were collected as part of a larger study where the aim was to investigate the effect of the implementation leadership support on implementation outcomes (ClinicalTrials.gov Identifier: NCT03042832).
Data were collected through online questionnaires before, during, and after TF-CBT was provided based on usual care. Routine procedures for trauma exposure screening and related posttraumatic stress symptoms were implemented. Those who scored above a predefined clinical cut-off were enrolled into TF-CBT based on the child and her or his caregiver's consent.
The aim of the study is to investigate the patient outcomes and therapeutic processes in TF-CBT.
- Conditions
- Trauma, Mental Health Disorder, PTSD, Implementation
- Being tested
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- Keywords
- TF-CBT, Trauma treatment, PTSD and Complex PTSD, Mental health organization
- Medical subject headings
- Wounds and Injuries, Mental Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused cognitive behavioral therapy (TF-CBT)Other
Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based method for the treatment of posttraumatic stress among youth.
| Study group | Role | What they receive |
|---|---|---|
| TF-CBT | Trauma-focused cognitive-behavioral therapy (TF-CBT), an evidence-based method for the treatment of posttraumatic stress among youth, was provided to children and adolescents referred to CAMHS. Receives: Other: Trauma-focused cognitive behavioral therapy (TF-CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CATS-II (Child and Adolescent Trauma Screen, version II)
The child´s exposure to potential traumatizing events and posttraumatic stress disorder (PTSD) and complex PTSD (CPTSD) will be measured before, during, and after TF-CBT.
Measured: 2018-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jan 2018
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 216 participants (actual)
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
- Responsible party
- Principal investigator, Ane-Marthe Solheim Skar, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Ane-Marthe S Skar, PhD, Principal investigator, Norwegian Center for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226481
- Sponsor's protocol ID
- Implementation of TF-CBT
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth
- ClinicalTrials.gov ID
- NCT05226481
- Acronym / sponsor ID
- Implementation of TF-CBT
- Conditions
- Trauma, Mental Health Disorder, PTSD, Implementation
- Keywords
- TF-CBT, Trauma treatment, PTSD and Complex PTSD, Mental health organization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Collaborators
- Ministry of Health and Care Services, Norway
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 7 Feb 2022 (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.
Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based practice (EBP) for the treatment of posttraumatic stress disorder (PTSD) and posttraumatic stress symptoms (PTSS) among children and adolescents. In the current study, data were collected from youth receiving TF-CBT in specialized child and adolescent mental health services (CAMHS) and their caregivers in 2018-2021.
Detailed description
Implementation of TF-CBT is a state-wide initiative, funded by the Norwegian Ministry of Health and Care Services, and is without costs for the clinics and patients. The Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the project. TF-CBT trainers at NKVTS train therapists at the participating CAMHS in TF-CBT. Data are collected to monitor the training and patient outcomes. Data are collected anonymously to support and ensure high-quality treatment and also provide the opportunity to investigate the effect of the implementation of TF-CBT in Norwegian CAMHS. In the period 2018-2021, additional data were collected as part of a larger study where the aim was to investigate the effect of the implementation leadership support on implementation outcomes (ClinicalTrials.gov Identifier: NCT03042832).
Data were collected through online questionnaires before, during, and after TF-CBT was provided based on usual care. Routine procedures for trauma exposure screening and related posttraumatic stress symptoms were implemented. Those who scored above a predefined clinical cut-off were enrolled into TF-CBT based on the child and her or his caregiver's consent.
The aim of the study is to investigate the patient outcomes and therapeutic processes in TF-CBT.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TF-CBT | – | Other: Trauma-focused cognitive behavioral therapy (TF-CBT)Trauma-focused cognitive-behavioral therapy (TF-CBT), an evidence-based method for the treatment of posttraumatic stress among youth, was provided to children and adolescents referred to CAMHS. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Routine trauma and PTSS screening among children and adolescents (aged 6-18 years) referred to CAMHS.
Key inclusion criteria (2 listed)
- Referred to Norwegian CAMHS
- Screened for trauma exposure and PTSS
Key exclusion criteria (1 listed)
- Below the age of 6 and above the age of 18
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 |
|---|---|---|
| Trauma-focused cognitive behavioral therapy (TF-CBT)Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based method for the treatment of posttraumatic stress among youth. | Other | TF-CBT |
Primary outcome
CATS-II (Child and Adolescent Trauma Screen, version II)
Time frame: 2018-2021
The child´s exposure to potential traumatizing events and posttraumatic stress disorder (PTSD) and complex PTSD (CPTSD) will be measured before, during, and after TF-CBT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ane-Marthe S Skar, PhD principal investigator
Norwegian Center for Violence and Traumatic Stress Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Mental Health Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CATS-II (Child and Adolescent Trauma Screen, version II) (time frame: 2018-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.