Narrative Exposure TherapyNCT02425280
Effectiveness of Narrative Exposure Therapy Among Refugee Children and Adolescents
A study testing Narrative Exposure Therapy and Treatment as Usual in people with Narrative Exposure Therapy and Treatment as Usual, run by Tampere University at 3 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Narrative Exposure Therapy, Treatment as Usual
- What is being tested?
- Narrative Exposure Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFinland
- Study dates
- Nov 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- acute psychosis
- intellectual disability
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Centre for Torture Survivors
Helsinki
Family Counselling Centre of the City of Tampere
Tampere
Psychiatric Clinic for Traumatized Children at Tampere University Hospital
Tampere
About this study
Official title: 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.
- Conditions
- Narrative Exposure Therapy, Treatment as Usual
- Being tested
- Narrative Exposure Therapy, Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
Treatment as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy | Experimental | 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). Receives: Behavioral: Narrative Exposure Therapy |
| Treatment as Usual | Active comparator | For the TAU control group, participants will receive the usual care for posttraumatic stress symptoms currently offered by each unit. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Stress as measured by Revised Impact of Event Scale
Measured: 9 months
Depression as measured by Depression Self-Rating Scale for Children
Measured: 9 months
Psychological Distress as measured by Strengths and Difficulties Questionnaire
Measured: 9 months
Resilience as measured by Child and Youth Resilience Measure
Measured: 9 months
Cognitive Performance as measured by Working Memory Test Battery for Children
Measured: 9 months
Secondary outcomes (3)
Quality of Traumatic Memory as measured by Trauma Memory Quality Questionnaire
Measured: 9 months
Trauma Related Cognitions as measured by Children's Post Traumatic Cognitions Inventory
Measured: 9 months
General functioning of autobiographical memory as measured by reported life events
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narrative Exposure TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsi Peltonen, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425280
- Sponsor's protocol ID
- 275804
- Status last verified
- Oct 2018
- First submitted
- 15 Apr 2015
- Last updated
- 17 Oct 2018
- Results posted
- No
Publications
Kangaslampi S, Garoff F, Peltonen K. Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change. BMC Psychiatry. 2015 Jun 17;15:127. doi: 10.1186/s12888-015-0520-z.
PubMed 26081580
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Help War-affected Children and Adolescents: the Role of Memory Functions in Therapeutic Intervention
- ClinicalTrials.gov ID
- NCT02425280
- Acronym / sponsor ID
- 275804
- Conditions
- Narrative Exposure Therapy, Treatment as Usual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Behavioral: Narrative Exposure TherapyFor 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). |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualFor the TAU control group, participants will receive the usual care for posttraumatic stress symptoms currently offered by each unit. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- acute psychosis
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure Therapy | Behavioural | Narrative Exposure Therapy |
| Treatment as Usual | Behavioural | Treatment as Usual |
Primary outcome
Post-traumatic Stress as measured by Revised Impact of Event Scale
Time frame: 9 months
Depression as measured by Depression Self-Rating Scale for Children
Time frame: 9 months
Psychological Distress as measured by Strengths and Difficulties Questionnaire
Time frame: 9 months
Resilience as measured by Child and Youth Resilience Measure
Time frame: 9 months
Cognitive Performance as measured by Working Memory Test Battery for Children
Time frame: 9 months
3 secondary outcomes
Quality of Traumatic Memory as measured by Trauma Memory Quality Questionnaire
Time frame: 9 months
Trauma Related Cognitions as measured by Children's Post Traumatic Cognitions Inventory
Time frame: 9 months
General functioning of autobiographical memory as measured by reported life events
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 26081580Kangaslampi S, Garoff F, Peltonen K. Narrative exposure therapy for immigrant children traumatized by war: study protocol for a randomized controlled trial of effectiveness and mechanisms of change. BMC Psychiatry. 2015 Jun 17;15:127. doi: 10.1186/s12888-015-0520-z.
Related trials for Narrative Exposure Therapy
Recruiting
The New Empowerment After eXposure to Trauma (NEXT) Study
PTSD - Post Traumatic Stress Disorder, PTSD (Childbirth-Related)
Not yet recruiting
What is the Feasibility of Narrative Exposure Therapy (NET) for People Experiencing Psychosis?
Psychosis, Schizophrenia and Other Psychotic Disorders
Recruiting
Empowering Narratives
PTSD - Post Traumatic Stress Disorder, Depression Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy and Treatment as Usual in people with Narrative Exposure Therapy and Treatment as Usual, run by Tampere University at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress as measured by Revised Impact of Event Scale (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.