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

• Sponsor: Norwegian Center for Violence and Traumatic Stress Studies (Other)
• Overall Status: Completed
• CT.gov ID: NCT05226481
• Collaborator: Ministry of Health and Care Services, Norway (Other)
• Enrollment: 216
• Location: 1
• Actual Duration (Months): 47.6
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma; Mental Health Disorder; PTSD; Implementation	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 Design

• Study Type: Observational
• Actual Enrollment: 216 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Investigating the Effect of Evidence-based Treatment for Post-traumatic Stress Disorder Among Youth
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 21, 2021
• Actual Study Completion Date: Dec 21, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. CATS-II (Child and Adolescent Trauma Screen, version II) [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 Outcome Measures

1. Therapeutic Alliance for Youth and Caregivers (TASC) [2018-2021]

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

2. Cognitions [2018-2021]

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

3. Fidelity in TF-CBT [2018-2021]

   Audio recordings of therapy sessions will be scored for fidelity.

4. Life quality (EQ-5D-Y) [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 [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) [2018-2021]

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

7. Pediatric Symptom Checklist (PSC) [2018-2021]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ane-Marthe Skar	Oslo		Norway	0655

Sponsors and Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies
• Ministry of Health and Care Services, Norway

Investigators

• Principal Investigator: Ane-Marthe S Skar, PhD, Norwegian Center for Violence and Traumatic Stress Studies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ane-Marthe Solheim Skar, Project leader, Norwegian Center for Violence and Traumatic Stress Studies
• ClinicalTrials.gov Identifier: NCT05226481
• Other Study ID Numbers: Implementation of TF-CBT
• First Posted: Feb 7, 2022
• Last Update Posted: Feb 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ane-Marthe Solheim Skar, Project leader, Norwegian Center for Violence and Traumatic Stress Studies: TF-CBT; Trauma treatment; PTSD and Complex PTSD; Mental health organization
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders

Study Results

No Results Posted as of Feb 7, 2022