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.

Study Overview

• Status: Completed
• Conditions: PTSD; Trauma; Mental Health Disorder; Implementation
• Intervention / Treatment: Other: Trauma-focused cognitive behavioral therapy (TF-CBT)

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 Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0655
    • Ane-Marthe Skar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Routine trauma and PTSS screening among children and adolescents (aged 6-18 years) referred to CAMHS.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2018-2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Alliance for Youth and Caregivers (TASC)	Therapeutic alliance will be measured during and after TF-CBT.	2018-2021
Cognitions	Cognitions will be measured with the Child Post-Traumatic Cognitions Inventory (CPTCI)	2018-2021
Fidelity in TF-CBT	Audio recordings of therapy sessions will be scored for fidelity.	2018-2021
Life quality (EQ-5D-Y)	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	2018-2021
Loneliness	Loneliness will be measured by items developed by the study group before, during and after TF-CBT.	2018-2021
The Client Satisfaction Questionnaire (CSQ)	Client satisfaction will be measured with the The Client Satisfaction Questionnaire (CSQ) after TF-CBT.	2018-2021
Pediatric Symptom Checklist (PSC)	Emotional and behavioral problems will be measured with the Pediatric Symptom Checklist (PSC) before, during and after TF-CBT	2018-2021

Collaborators and Investigators

• Sponsor: Norwegian Center for Violence and Traumatic Stress Studies
• Collaborators: Ministry of Health and Care Services, Norway
• Investigators: Principal Investigator: Ane-Marthe S Skar, PhD, Norwegian Center for Violence and Traumatic Stress Studies

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Trauma treatment; TF-CBT; PTSD and Complex PTSD; Mental health organization
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders
• Other Study ID Numbers: Implementation of TF-CBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No