Short-term Intervention and Health Trajectories After Mass Trauma

• Sponsor: Norwegian Center for Violence and Traumatic Stress Studies (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05042323
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Behavioral: TF-CBT-Short	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Mar 15, 2031

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PTSD [Pre-treatment]

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

2. PTSD [After 5 weeks]

   Measured with the CATS (after 4-5 sessions)

3. PTSD [After 9 weeks]

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

4. PTSD [After 21 weeks]

   Measured with the CATS

5. PTSD [After 33 weeks]

   Measured with the CATS

6. PTSD [After 45 weeks]

   Measured with the CATS

7. PTSD [After 57 weeks]

   Measured with the CATS

Secondary Outcome Measures

1. Depression [Pre-treatment]

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

2. Depression [After 5 weeks]

   Measured with MFQ-short

3. Depression [After 9 weeks]

   Measured with MFQ-short

4. Depression [After 21 weeks]

   Measured with MFQ-short

5. Depression [After 33 weeks]

   Measured with MFQ-short

6. Depression [After 45 weeks]

   Measured with MFQ-short

7. Depression [After 57 weeks]

   Measured with MFQ-short

Other Outcome Measures

1. Anxiety [Pre-treatment]

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

2. Anxiety [After 5 weeks]

   Measured with SCARED-5 Item

3. Anxiety [After 9 weeks]

   Measured with SCARED-5 Item

4. Anxiety [After 21 weeks]

   Measured with SCARED-5 Item

5. Anxiety [After 33 weeks]

   Measured with SCARED-5 Item

6. Anxiety [After 45 weeks]

   Measured with SCARED-5 Item

7. Anxiety [After 57 weeks]

   Measured with SCARED-5 Item

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norwegian center for violence and traumatic stress studies	Oslo		Norway

Sponsors and Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian Center for Violence and Traumatic Stress Studies
• ClinicalTrials.gov Identifier: NCT05042323
• Other Study ID Numbers: Gjerdrum
• First Posted: Sep 13, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 13, 2021