Skip to main content
OpenTrials
Completed

NCT Number: NCT05226481

Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ane-Marthe Skar

Oslo, 0655, Norway

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Other outcomes

  1. Therapeutic Alliance for Youth and Caregivers (TASC)

    Time frame: 2018-2021

    Therapeutic alliance will be measured during and after TF-CBT.

  2. Cognitions

    Time frame: 2018-2021

    Cognitions will be measured with the Child Post-Traumatic Cognitions Inventory (CPTCI)

  3. Fidelity in TF-CBT

    Time frame: 2018-2021

    Audio recordings of therapy sessions will be scored for fidelity.

  4. Life quality (EQ-5D-Y)

    Time frame: 2018-2021

    Life quality will be measured with the EQ-5D-Y (a child- and age-specific measure of the health-related quality of life (HRQoL)) before, during and after TF-CBT

  5. Loneliness

    Time frame: 2018-2021

    Loneliness will be measured by items developed by the study group before, during and after TF-CBT.

  6. The Client Satisfaction Questionnaire (CSQ)

    Time frame: 2018-2021

    Client satisfaction will be measured with the The Client Satisfaction Questionnaire (CSQ) after TF-CBT.

  7. Pediatric Symptom Checklist (PSC)

    Time frame: 2018-2021

    Emotional and behavioral problems will be measured with the Pediatric Symptom Checklist (PSC) before, during and after TF-CBT

Sponsors and collaborators

Lead sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Other

Collaborators

  • Ministry of Health and Care Services, Norway

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.