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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
Norwegian Center for Violence and Traumatic Stress Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

6 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 14, 2021
Last Updated
May 13, 2023
Sponsor
Norwegian Center for Violence and Traumatic Stress Studies
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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

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Short-term Intervention and Health Trajectories After Mass Trauma

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