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Completed

NCT Number: NCT05042323

Short-term 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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

6 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian center for violence and traumatic stress studies

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TF-CBT-Short

Behavioral

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 outcomes

  1. PTSD

    Time frame: Pre-treatment

    Measured with the Child and adolescent trauma screen (CATS). Range 0-60. Higher score means worse outcome.

  2. PTSD

    Time frame: After 5 weeks

    Measured with the CATS (after 4-5 sessions)

  3. PTSD

    Time frame: After 9 weeks

    Measured with the CATS (for those who continue to Step two)

  4. PTSD

    Time frame: After 21 weeks

    Measured with the CATS

  5. PTSD

    Time frame: After 33 weeks

    Measured with the CATS

  6. PTSD

    Time frame: After 45 weeks

    Measured with the CATS

  7. PTSD

    Time frame: After 57 weeks

    Measured with the CATS

Secondary outcomes

  1. Depression

    Time frame: Pre-treatment

    Measured with Moods and feelings questionaire (MFQ-short). Range 0-13. Higher scores means worse outcome.

  2. Depression

    Time frame: After 5 weeks

    Measured with MFQ-short

  3. Depression

    Time frame: After 9 weeks

    Measured with MFQ-short

  4. Depression

    Time frame: After 21 weeks

    Measured with MFQ-short

  5. Depression

    Time frame: After 33 weeks

    Measured with MFQ-short

  6. Depression

    Time frame: After 45 weeks

    Measured with MFQ-short

  7. Depression

    Time frame: After 57 weeks

    Measured with MFQ-short

Other outcomes

  1. Anxiety

    Time frame: Pre-treatment

    Measured with Screen for Child Anxiety Related Emotional Disorders (SCARED-5 Item)

  2. Anxiety

    Time frame: After 5 weeks

    Measured with SCARED-5 Item

  3. Anxiety

    Time frame: After 9 weeks

    Measured with SCARED-5 Item

  4. Anxiety

    Time frame: After 21 weeks

    Measured with SCARED-5 Item

  5. Anxiety

    Time frame: After 33 weeks

    Measured with SCARED-5 Item

  6. Anxiety

    Time frame: After 45 weeks

    Measured with SCARED-5 Item

  7. Anxiety

    Time frame: After 57 weeks

    Measured with SCARED-5 Item

Sponsors and collaborators

Lead sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 13, 2021
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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