Clinical trial NCT05226481: Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth
Official title: Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Mental Health Disorder
PTSD
Implementation
Keywords: TF-CBT
Trauma treatment
PTSD and Complex PTSD
Mental health organization
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Care Services, Norway
First posted: 2022-02-07
Enrollment: 216
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Routine trauma and PTSS screening among children and adolescents (aged 6-18 years) referred to CAMHS.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Referred to Norwegian CAMHS
* Screened for trauma exposure and PTSS

Exclusion Criteria:

* Below the age of 6 and above the age of 18

Primary outcomes:
measure: CATS-II (Child and Adolescent Trauma Screen, version II)
timeFrame: 2018-2021
Secondary outcomes:
Other outcomes:
measure: Therapeutic Alliance for Youth and Caregivers (TASC)
timeFrame: 2018-2021
measure: Cognitions
timeFrame: 2018-2021
measure: Fidelity in TF-CBT
timeFrame: 2018-2021
measure: Life quality (EQ-5D-Y)
timeFrame: 2018-2021
measure: Loneliness
timeFrame: 2018-2021
measure: The Client Satisfaction Questionnaire (CSQ)
timeFrame: 2018-2021
measure: Pediatric Symptom Checklist (PSC)
timeFrame: 2018-2021
Locations:
city: Oslo
country: Norway
facility: Ane-Marthe Skar
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies
name: Ane-Marthe S Skar, PhD
role: PRINCIPAL_INVESTIGATOR
References: