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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226481
• Other study ID #: Implementation of TF-CBT
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 21, 2021

Study information

• Verified date: February 2022
• Source: Norwegian Center for Violence and Traumatic Stress Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Implementation
• Mental Disorders
• Mental Health Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma

Intervention

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.

Locations

Country	Name	City	State
Norway	Ane-Marthe Skar	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Center for Violence and Traumatic Stress Studies	Ministry of Health and Care Services, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapeutic Alliance for Youth and Caregivers (TASC)	Therapeutic alliance will be measured during and after TF-CBT.	2018-2021
Other	Cognitions	Cognitions will be measured with the Child Post-Traumatic Cognitions Inventory (CPTCI)	2018-2021
Other	Fidelity in TF-CBT	Audio recordings of therapy sessions will be scored for fidelity.	2018-2021
Other	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
Other	Loneliness	Loneliness will be measured by items developed by the study group before, during and after TF-CBT.	2018-2021
Other	The Client Satisfaction Questionnaire (CSQ)	Client satisfaction will be measured with the The Client Satisfaction Questionnaire (CSQ) after TF-CBT.	2018-2021
Other	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
Primary	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