- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425280
Effectiveness of Narrative Exposure Therapy Among Refugee Children and Adolescents
October 15, 2018 updated by: Kirsi Peltonen, Tampere University
How to Help War-affected Children and Adolescents: the Role of Memory Functions in Therapeutic Intervention
This study aims to understand how war trauma affects children's and adolescents' memory functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing optimal memory functions and alleviating mental health problems.
The study analyzes the mental health and cognitive and emotional healing mechanisms of therapeutic intervention among war-affected children and adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland
- Centre for Torture Survivors
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Tampere, Finland
- Family Counselling Centre of the City of Tampere
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Tampere, Finland
- Psychiatric Clinic for Traumatized Children at Tampere University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 9-17 years old
- has spent some part of her/his life living in a country where organized violence was taking place, or at a refugee camp
- suffers from significant stress symptoms thought be trauma-related
Exclusion Criteria:
- acute psychosis
- intellectual disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Narrative Exposure Therapy
For the intervention group receiving Narrative Exposure Therapy treatment, the intervention will last for approximately three months and include 10-12 weekly sessions of 60-90 minutes.
The course of the intervention will follow the NET manual (Schauer et al., 2011).
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Active Comparator: Treatment as Usual
For the TAU control group, participants will receive the usual care for posttraumatic stress symptoms currently offered by each unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post-traumatic Stress as measured by Revised Impact of Event Scale
Time Frame: 9 months
|
9 months
|
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Depression as measured by Depression Self-Rating Scale for Children
Time Frame: 9 months
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9 months
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Psychological Distress as measured by Strengths and Difficulties Questionnaire
Time Frame: 9 months
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9 months
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Resilience as measured by Child and Youth Resilience Measure
Time Frame: 9 months
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9 months
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Cognitive Performance as measured by Working Memory Test Battery for Children
Time Frame: 9 months
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9 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quality of Traumatic Memory as measured by Trauma Memory Quality Questionnaire
Time Frame: 9 months
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9 months
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Trauma Related Cognitions as measured by Children's Post Traumatic Cognitions Inventory
Time Frame: 9 months
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9 months
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General functioning of autobiographical memory as measured by reported life events
Time Frame: 9 months
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9 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Subjective distress during therapy measured by Subjective Units of Distress Scale
Time Frame: 9 months
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9 months
|
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Peritraumatic Dissociation measured by Peritraumatic Dissociative Experiences Questionnaire
Time Frame: once, at baseline
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once, at baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2014
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
April 15, 2015
First Submitted That Met QC Criteria
April 22, 2015
First Posted (Estimate)
April 23, 2015
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 15, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 275804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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