Short-term Intervention and Health Trajectories After Mass Trauma
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
TF-CBT-Short
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Exposed to the landslide
- Between 6-19 years old
- A score of 15 or more on the CATS
- A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.
Exclusion Criteria:
- Suicidal
- Psychotic
Sites / Locations
- Norwegian center for violence and traumatic stress studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TF-CBT-Skills
TF-CBT-Narr
Arm Description
Step 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing
Step 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building
Outcomes
Primary Outcome Measures
PTSD
Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.
PTSD
Measured with the CATS (after 4-5 sessions)
PTSD
Measured with the CATS (for those who continue to Step two)
PTSD
Measured with the CATS
PTSD
Measured with the CATS
PTSD
Measured with the CATS
PTSD
Measured with the CATS
Secondary Outcome Measures
Depression
Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.
Depression
Measured with MFQ-short
Depression
Measured with MFQ-short
Depression
Measured with MFQ-short
Depression
Measured with MFQ-short
Depression
Measured with MFQ-short
Depression
Measured with MFQ-short
Full Information
NCT ID
NCT05042323
First Posted
March 14, 2021
Last Updated
May 13, 2023
Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
1. Study Identification
Unique Protocol Identification Number
NCT05042323
Brief Title
Short-term Intervention and Health Trajectories After Mass Trauma
Official Title
The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. The second is to understand what may be effective early interventions to prevent long-term health and psychosocial problems for youth (6-19). Participants are recruited from an outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted and screened for trauma related difficulties. Those who have significant post-trauma reactions are offered trauma focused interventions.
Detailed Description
Two short step-wise interventions are developed for this study as an early intervention after mass trauma based on components from TF-CBT to test the relative importance of dosage and the sequencing of components.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TF-CBT-Skills
Arm Type
Experimental
Arm Description
Step 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing
Arm Title
TF-CBT-Narr
Arm Type
Active Comparator
Arm Description
Step 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building
Intervention Type
Behavioral
Intervention Name(s)
TF-CBT-Short
Intervention Description
Participants receive either 4-5 sessions of TF-CBT-Skills or TF-CBT-Narr. If the participant still has significant PTSS they are provided with step two which is the components provided in the arm they did not receive.
Primary Outcome Measure Information:
Title
PTSD
Description
Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.
Time Frame
Pre-treatment
Title
PTSD
Description
Measured with the CATS (after 4-5 sessions)
Time Frame
After 5 weeks
Title
PTSD
Description
Measured with the CATS (for those who continue to Step two)
Time Frame
After 9 weeks
Title
PTSD
Description
Measured with the CATS
Time Frame
After 21 weeks
Title
PTSD
Description
Measured with the CATS
Time Frame
After 33 weeks
Title
PTSD
Description
Measured with the CATS
Time Frame
After 45 weeks
Title
PTSD
Description
Measured with the CATS
Time Frame
After 57 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.
Time Frame
Pre-treatment
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 5 weeks
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 9 weeks
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 21 weeks
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 33 weeks
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 45 weeks
Title
Depression
Description
Measured with MFQ-short
Time Frame
After 57 weeks
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Measured with Screen for Child Anxiety Related Emotional Disorders (SCARED-5 Item)
Time Frame
Pre-treatment
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 5 weeks
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 9 weeks
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 21 weeks
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 33 weeks
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 45 weeks
Title
Anxiety
Description
Measured with SCARED-5 Item
Time Frame
After 57 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Exposed to the landslide
Between 6-19 years old
A score of 15 or more on the CATS
A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.
Exclusion Criteria:
Suicidal
Psychotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine K Jensen, PhD
Organizational Affiliation
Norwegian Center for Violence and Traumatic Stress Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian center for violence and traumatic stress studies
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-term Intervention and Health Trajectories After Mass Trauma
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