Short-term Intervention and Health Trajectories After Mass Trauma

NCT05042323 | Completed

• 1 other identifier: Gjerdrum
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Depression

  Pre-treatment

• Depression

  After 5 weeks

• Depression

  After 9 weeks

• Depression

  After 21 weeks

• Depression

  After 33 weeks

Other Outcomes (7)

• Anxiety

  Pre-treatment

• Anxiety

  After 5 weeks

• Anxiety

  After 9 weeks

Study Arms (2)

TF-CBT-Skills

EXPERIMENTAL

Step 1: 4-5 sessions with stabilization/skill building Step 2: 4-5 sessions with narrative and cognitive processing

Behavioral: TF-CBT-Short

TF-CBT-Narr

ACTIVE COMPARATOR

Step 1: 4-5 sessions with narrative and cognitive processing Step 2: 4-5 sessions with stabilization/skill building

Behavioral: TF-CBT-Short

Interventions

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.

TF-CBT-Narr; TF-CBT-Skills

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Suicidal
• Psychotic

Sponsors & Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies: lead

Study Sites (1)

Norwegian center for violence and traumatic stress studies

Oslo, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Tine K Jensen, PhD

  Norwegian Center for Violence and Traumatic Stress Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: September 13, 2021
• Study Start: March 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: March 15, 2023
• Last Updated: May 16, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)