Short-term Intervention and Health Trajectories After Mass Trauma

The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: TF-CBT-Short

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Norwegian Center for Violence and Traumatic Stress Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TF-CBT-Skills; Step 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing	Behavioral: TF-CBT-Short; 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.
Active Comparator: TF-CBT-Narr; Step 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building	Behavioral: TF-CBT-Short; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD	Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.	Pre-treatment
PTSD	Measured with the CATS (after 4-5 sessions)	After 5 weeks
PTSD	Measured with the CATS (for those who continue to Step two)	After 9 weeks
PTSD	Measured with the CATS	After 21 weeks
PTSD	Measured with the CATS	After 33 weeks
PTSD	Measured with the CATS	After 45 weeks
PTSD	Measured with the CATS	After 57 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.	Pre-treatment
Depression	Measured with MFQ-short	After 5 weeks
Depression	Measured with MFQ-short	After 9 weeks
Depression	Measured with MFQ-short	After 21 weeks
Depression	Measured with MFQ-short	After 33 weeks
Depression	Measured with MFQ-short	After 45 weeks
Depression	Measured with MFQ-short	After 57 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Measured with Screen for Child Anxiety Related Emotional Disorders (SCARED-5 Item)	Pre-treatment
Anxiety	Measured with SCARED-5 Item	After 5 weeks
Anxiety	Measured with SCARED-5 Item	After 9 weeks
Anxiety	Measured with SCARED-5 Item	After 21 weeks
Anxiety	Measured with SCARED-5 Item	After 33 weeks
Anxiety	Measured with SCARED-5 Item	After 45 weeks
Anxiety	Measured with SCARED-5 Item	After 57 weeks

Collaborators and Investigators

• Sponsor: Norwegian Center for Violence and Traumatic Stress Studies
• Investigators: Principal Investigator: Tine K Jensen, PhD, Norwegian Center for Violence and Traumatic Stress Studies

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Gjerdrum

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