Post Traumatic Stress DisorderNCT05314829
Trauma Treatment in Norwegian Child Advocacy Centers
An observational study of Post Traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
Trial summary
Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2020to 31 Dec 2024
- 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: Children and adolescents who receive services at Norwegian child and adolescent advocacy centers. They are screened for posttraumatic reactions to the potential traumatising events that they have experienced, and are offered trauma-focused cognitive behavioral therapy if scoring above the clinical cut-off for PTS:
Who may be able to join
- Trauma exposure
- Post-traumatic stress symptoms above clinical cut-off
Who cannot join
- Clinical assessment concludes that the child should receive services in the child and adolescent specialist services
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Nowegian Center for Violence and Traumatic Stress Studies
Oslo, 0655
Ane-Marthe Skar, 97661591, amskar@gmail.com
About this study
Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere.
The current project will investigate four issues related to these knowledge needs;
- How do children and parents experience receiving trauma treatment at child advocacy centers?
- What predicts treatment effects?
- What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress?
Read the detailed description
Employees in the child advocacy centers (CAC) received training in trauma screening and a sub-sample received training in Trauma-Focused Cognitive Behavioral Therapy (TF-CBT).
To address the knowledge gaps, this project will answer the following research questions, corresponding to four Work Packages (WP):
- Youth's and caregiver´s experiences with trauma treatment in CACs: How do youth and caregivers experience receiving trauma treatment in Norwegian CACs, and how are their experiences affected by CACs dual role as both a forensic institution and a treatment institution?
- Response, non-response and dropout in trauma treatment in CACs: What predicts treatment outcomes for youth receiving TF-CBT in Norwegian CACs?
- Therapists' experiences with trauma treatment in CACs: How do therapists in Norwegian CACs experience job demands and job resources, including burnout and secondary traumatic stress, and how can working with TF-CBT influence this?
- Descriptive study of leadership, turnover, and secondary traumatic stress among staff in Norwegian Child Advocacy Centers.
To answer research question 1, qualitative interviews with children and caregivers will be conducted following their participation in TF-CBT.
For research question 2, quantitative data will be collected during the TF-CBT sessions. The child advocacy centers identify eligible TF-CBT clients through systematic trauma screening and establish routines for how TF-CBT is offered and delivered.
Research question 3 is qualitative, with semi-structured interviews with therapists.
Lastly, both questionnaire data and interviews will be used to answer research question 4.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Trauma-focused cognitive behavioral therapy (TF-CBT)
- Keywords
- PTSD, Child advocacy center, Childhood trauma
- Medical subject headings
- 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
TF-CBT is a phase-based evidence-based treatment method for children and adolescents between 6-18 years who experience posttraumatic stress symptoms following trauma exposure. Parents or other close caregivers receive parallel sessions. It is normally provided through 12-16 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Data will be collected from 2 child advocacy centers 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.
The Child and Adolescent Trauma Screen (CATS)
CATS is a screening instrument for PTSD based on the DSM-5 criterias.Total score range is between 0-60. A higher score indicates more symptoms, with a cut-off ≥ 21 as indication of a clinically relevant level of symptoms.
Measured: 2021-2023
Secondary outcomes (6)
Child Post-Traumatic Cognitions Inventory (cPTCI)
Measures maladaptive cognitions in children and young people following trauma exposure. Total score range is between 0-60. A higher score indicates more symptoms.
Measured: 2021-2023
Short Moods and Feelings Questionnaire (SMFQ)
Measures moods and feelings. Total score range is between 0-26. A higher score indicates more symptoms.
Measured: 2021-2023
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Measures social support. Total score range is between 8-40. The higher the average score, the greater the perceived social support.
Measured: 2021-2023
Project specific questionnaire, inspired by the Working Alliance Inventory (WAI)
Measures trust. Total score range is between 12-48. The higher the average score, the greater the perceived alliance.
Measured: 2021-2023
Client Satisfaction Questionnaire (to the caregiver)
Measures cilients satisfaction with TF-CBT. Total score range is between 0-32.The higher the average score, the greater client satisfaction.
Measured: 2021-2023
Child Satisfaction Questionnaire (developed by NKVTS)
3 items (children) developed by NKVTS, to measure child satisfaction with the treatment. Total score range from 3-12. The higher the average score, the higher child satisfaction.
Measured: 2021-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Aug 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ane-Marthe Solheim Skar, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Ane-Marthe Solheim Skar, Principal investigator, Norwegian Center for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314829
- Sponsor's protocol ID
- Child advocacy centers
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not included in the consent letter to the participants.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Treatment in Norwegian Child Advocacy Centers
- ClinicalTrials.gov ID
- NCT05314829
- Acronym / sponsor ID
- Child advocacy centers
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Child advocacy center, Childhood trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Apr 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.
Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere.
The current project will investigate four issues related to these knowledge needs;
- How do children and parents experience receiving trauma treatment at child advocacy centers?
- What predicts treatment effects?
- What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress?
Detailed description
Employees in the child advocacy centers (CAC) received training in trauma screening and a sub-sample received training in Trauma-Focused Cognitive Behavioral Therapy (TF-CBT).
To address the knowledge gaps, this project will answer the following research questions, corresponding to four Work Packages (WP):
- Youth's and caregiver´s experiences with trauma treatment in CACs: How do youth and caregivers experience receiving trauma treatment in Norwegian CACs, and how are their experiences affected by CACs dual role as both a forensic institution and a treatment institution?
- Response, non-response and dropout in trauma treatment in CACs: What predicts treatment outcomes for youth receiving TF-CBT in Norwegian CACs?
- Therapists' experiences with trauma treatment in CACs: How do therapists in Norwegian CACs experience job demands and job resources, including burnout and secondary traumatic stress, and how can working with TF-CBT influence this?
- Descriptive study of leadership, turnover, and secondary traumatic stress among staff in Norwegian Child Advocacy Centers.
To answer research question 1, qualitative interviews with children and caregivers will be conducted following their participation in TF-CBT.
For research question 2, quantitative data will be collected during the TF-CBT sessions. The child advocacy centers identify eligible TF-CBT clients through systematic trauma screening and establish routines for how TF-CBT is offered and delivered.
Research question 3 is qualitative, with semi-structured interviews with therapists.
Lastly, both questionnaire data and interviews will be used to answer research question 4.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Trauma-focused cognitive behavioral therapy (TF-CBT)Data will be collected from 2 child advocacy centers |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents who receive services at Norwegian child and adolescent advocacy centers. They are screened for posttraumatic reactions to the potential traumatising events that they have experienced, and are offered trauma-focused cognitive behavioral therapy if scoring above the clinical cut-off for PTS:
Key inclusion criteria (2 listed)
- Trauma exposure
- Post-traumatic stress symptoms above clinical cut-off
Key exclusion criteria (1 listed)
- Clinical assessment concludes that the child should receive services in the child and adolescent specialist services
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)TF-CBT is a phase-based evidence-based treatment method for children and adolescents between 6-18 years who experience posttraumatic stress symptoms following trauma exposure. Parents or other close caregivers receive parallel sessions. It is normally provided through 12-16 sessions. | Other | Study group |
Primary outcome
The Child and Adolescent Trauma Screen (CATS)
Time frame: 2021-2023
CATS is a screening instrument for PTSD based on the DSM-5 criterias.Total score range is between 0-60. A higher score indicates more symptoms, with a cut-off ≥ 21 as indication of a clinically relevant level of symptoms.
6 secondary outcomes
Child Post-Traumatic Cognitions Inventory (cPTCI)
Time frame: 2021-2023
Short Moods and Feelings Questionnaire (SMFQ)
Time frame: 2021-2023
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time frame: 2021-2023
Project specific questionnaire, inspired by the Working Alliance Inventory (WAI)
Time frame: 2021-2023
Client Satisfaction Questionnaire (to the caregiver)
Time frame: 2021-2023
Child Satisfaction Questionnaire (developed by NKVTS)
Time frame: 2021-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No. This is not included in the consent letter to the participants.
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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 Solheim Skar 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 Post Traumatic Stress 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: status not confirmed, as of the sponsor's last update on 30 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ane-Marthe S Skar, PhD (+4797661591, a.m.s.skar@nkvts.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Child and Adolescent Trauma Screen (CATS) (time frame: 2021-2023). 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 30 Sep 2022.