Mental Health DisorderNCT03822598
Promoting Asylum-seeking and Refugee Children's Coping With Trauma
A study testing Teaching Recovery Techniques, TRT in people with Mental Health Disorder and Post-Traumatic Stress Disorder in Adolescence, run by Norwegian Institute of Public Health at 16 sites in Norway.
Trial summary
A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children. The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Mental Health Disorder, Post-Traumatic Stress Disorder in Adolescence, Depression
- What is being tested?
- Teaching Recovery Techniques, TRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 16 sitesNorway
- Study dates
- 20 Jun 2017to 30 Jun 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Accompanied asylum-seeking children living in reception centers,
- Unaccompanied asylum-seeking children living in reception centers
- Unaccompanied refugee minors who have been granted residence
- Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items
- -
Who cannot join
- Psychosis,
- Mental disabilities
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Norway16 sites
Bergen Municipality
Bergen
Nordre Land municipality
Dokka
Drammen Municipality
Drammen
Engerdal Municipality
Drevsjø
Fredrikstad municipality
Fredrikstad
Gjøvik municipality
Gjøvik
Ringerike Municipality
Hønefoss
Grue municipality
Kirkenær
Levanger municipality
Leira
Lyngdal municipality
Lyng
Lyngdal municipality
Lyngdal
Bærum municipality
Rud
Salten municipality
Sjøvegan
Stavanger municipality
Stavanger
Trondheim municipality
Trondheim
Vadsø municipality
Vadsø
About this study
Official title: Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children
A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children.
The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.
Read the detailed description
Teaching Recovery Techniques (TRT) was developed by Children and War Foundation (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental reactions to being exposed to war and catastrophes. TRT has proven to be effective in reducing trauma-related mental health symptoms in such contexts. However, it has never been used with children experiencing all the uncertainties and stress of an asylum-seeking context, or with refugee children in high-income countries. The main aim of the present study is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in the context of four different care conditions: 1)asylum-seeking children who arrived accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and older living in asylum centers regulated by the Directorate of Immigration 4) Former unaccompanied asylum-seeking children who have been granted residence (refugees) and are resettled in a municipality in Norway.
Based on Power analyses, the target group is 40 children in each care condition (total n = 160) > 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.
The study employs a randomized clustered experimental design that includes a waiting list control group, which will receive the TRT when the intervention group has completed the program.
- Conditions
- Mental Health Disorder, Post-Traumatic Stress Disorder in Adolescence, Depression, Social Anxiety
- Being tested
- Teaching Recovery Techniques, TRT
- Keywords
- Teaching Recovery Techniques, Asylum-seeking children, Refugee children, Low-threshold intervention
- Medical subject headings
- Mental Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching Recovery Techniques, TRTBehavioural
TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Teaching Recovery Techniques implemented 1- 3 weeks after recruitment Receives: Behavioral: Teaching Recovery Techniques, TRT |
| Wait-list control group | Active comparator | Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program) Receives: Behavioral: Teaching Recovery Techniques, TRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Revised Impact of Event Scale (CRIES-13)
Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)
Measured: Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary outcomes (3)
Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
Measures if children have perceived each anxiety symptom over the last three months from "not true, or hardly ever true" (0), "somewhat true or sometimes true" (1) "very true or often true" (2)
Measured: Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Cantril Ladder
Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)
Measured: Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Montgomery-Aasberg Depression Scale, MADRS
9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).
Measured: Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start20 Jun 2017
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- University of Tromso, University of Bergen, The Norwegian Directorate for Children, Youth and Family Affairs, Norwegian Directorate of Immigration, Norwegian Directorate of Integration and Diversity
- Responsible party
- Principal investigator, Brit Oppedal, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822598
- Sponsor's protocol ID
- 16/54571
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children
- ClinicalTrials.gov ID
- NCT03822598
- Acronym / sponsor ID
- 16/54571
- Conditions
- Mental Health Disorder, Post-Traumatic Stress Disorder in Adolescence, Depression, Social Anxiety
- Keywords
- Teaching Recovery Techniques, Asylum-seeking children, Refugee children, Low-threshold intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- University of Tromso, University of Bergen, The Norwegian Directorate for Children, Youth and Family Affairs, Norwegian Directorate of Immigration, Norwegian Directorate of Integration and Diversity
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 Jan 2019 (actual)
- 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.
A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children.
The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.
Detailed description
Teaching Recovery Techniques (TRT) was developed by Children and War Foundation (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental reactions to being exposed to war and catastrophes. TRT has proven to be effective in reducing trauma-related mental health symptoms in such contexts. However, it has never been used with children experiencing all the uncertainties and stress of an asylum-seeking context, or with refugee children in high-income countries. The main aim of the present study is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in the context of four different care conditions: 1)asylum-seeking children who arrived accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and older living in asylum centers regulated by the Directorate of Immigration 4) Former unaccompanied asylum-seeking children who have been granted residence (refugees) and are resettled in a municipality in Norway.
Based on Power analyses, the target group is 40 children in each care condition (total n = 160) > 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.
The study employs a randomized clustered experimental design that includes a waiting list control group, which will receive the TRT when the intervention group has completed the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Teaching Recovery Techniques, TRTTeaching Recovery Techniques implemented 1- 3 weeks after recruitment |
| Wait-list control group | Active comparator | Behavioral: Teaching Recovery Techniques, TRTDelayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program) |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Accompanied asylum-seeking children living in reception centers,
- Unaccompanied asylum-seeking children living in reception centers
- Unaccompanied refugee minors who have been granted residence
- Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items
- -
Key exclusion criteria (2 listed)
- Psychosis,
- Mental disabilities
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 |
|---|---|---|
| Teaching Recovery Techniques, TRTTRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy | Behavioural | Intervention group, Wait-list control group |
Primary outcome
Children's Revised Impact of Event Scale (CRIES-13)
Time frame: Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)
3 secondary outcomes
Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
Time frame: Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Cantril Ladder
Time frame: Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Montgomery-Aasberg Depression Scale, MADRS
Time frame: Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
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 30 Jan 2019.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching Recovery Techniques, TRT in people with Mental Health Disorder and Post-Traumatic Stress Disorder in Adolescence, run by Norwegian Institute of Public Health at 16 sites in Norway.
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 5 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Norway. 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?
Children's Revised Impact of Event Scale (CRIES-13) (time frame: Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.