Short-term Intervention and Health Trajectories After Mass Trauma

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042323
• Other study ID #: Gjerdrum
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: September 2021
• Source: Norwegian Center for Violence and Traumatic Stress Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 15, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Norway	Norwegian center for violence and traumatic stress studies	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Center for Violence and Traumatic Stress Studies

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety	Measured with Screen for Child Anxiety Related Emotional Disorders (SCARED-5 Item)	Pre-treatment
Other	Anxiety	Measured with SCARED-5 Item	After 5 weeks
Other	Anxiety	Measured with SCARED-5 Item	After 9 weeks
Other	Anxiety	Measured with SCARED-5 Item	After 21 weeks
Other	Anxiety	Measured with SCARED-5 Item	After 33 weeks
Other	Anxiety	Measured with SCARED-5 Item	After 45 weeks
Other	Anxiety	Measured with SCARED-5 Item	After 57 weeks
Primary	PTSD	Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.	Pre-treatment
Primary	PTSD	Measured with the CATS (after 4-5 sessions)	After 5 weeks
Primary	PTSD	Measured with the CATS (for those who continue to Step two)	After 9 weeks
Primary	PTSD	Measured with the CATS	After 21 weeks
Primary	PTSD	Measured with the CATS	After 33 weeks
Primary	PTSD	Measured with the CATS	After 45 weeks
Primary	PTSD	Measured with the CATS	After 57 weeks
Secondary	Depression	Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.	Pre-treatment
Secondary	Depression	Measured with MFQ-short	After 5 weeks
Secondary	Depression	Measured with MFQ-short	After 9 weeks
Secondary	Depression	Measured with MFQ-short	After 21 weeks
Secondary	Depression	Measured with MFQ-short	After 33 weeks
Secondary	Depression	Measured with MFQ-short	After 45 weeks
Secondary	Depression	Measured with MFQ-short	After 57 weeks