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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05042323
Other study ID # Gjerdrum
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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