Post Traumatic Stress DisorderPhase 1NCT01612104
Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
A Phase 1 study testing Psychological First Aid in people with Post Traumatic Stress Disorder and Adjustment Disorder, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial summary
The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Adjustment Disorder
- What is being tested?
- Psychological First Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2012to Aug 2015
- Phase
- Phase 1
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children/adolescents that:
- contact "The Children's House in Oslo" after having experienced potential traumatic event(s).
- are assessed as having psychological symptoms related to potential trauma
- are between 11 and 16 years old
- agree to participate in the study (both the youth and his/her parents(s)
- understand and speak Norwegian
Who cannot join
- Children/adolescents with:
- mental retardation
- reading skills below 8 year
- psychosis
- high risk of suicidal behavior is assumed
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.
- Being tested
- Psychological First Aid
- Keywords
- Post Traumatic Stress Disorder, Anxiety symptoms, Depressive symptoms, Externalizing behavior, Reduced quality of life
- Medical subject headings
- Stress Disorders, Post-Traumatic, Adjustment Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological First AidBehavioural
A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma
| Study group | Role | What they receive |
|---|---|---|
| Psychological First Aid | Experimental | Psychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help. Receives: Behavioral: Psychological First Aid |
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)
Measured: One year
Secondary outcomes (1)
Child Post-Traumatic Cognition Inventory (CPTCI)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bente SM Haugland, PhD, Principal investigator, Centre for Child and Adolescent Mental Health, Western Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612104
- Sponsor's protocol ID
- RKBU62
- Status last verified
- Dec 2015
- First submitted
- 31 May 2012
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological First Aid With Children in a High Risk Group - a Repeated Single Case Design
- ClinicalTrials.gov ID
- NCT01612104
- Acronym / sponsor ID
- RKBU62
- Keywords
- Post Traumatic Stress Disorder, Anxiety symptoms, Depressive symptoms, Externalizing behavior, Reduced quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Jun 2012 (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.
The purpose of this pilot-study is to evaluate a cognitive behavioral method "Psychological First Aid" used with a group of children (11-16 years) in high risk of developing psychological problems. Participants are recruited from a low-threshold program ("The Children's House in Oslo") where counseling is given to children suspected of being physically or sexually abused, or having witnessed domestic violence. The study includes twelve children and teenagers that receive 2 to 6 sessions of counseling. Psychological problems (e.g. anxiety, depression, reactions to trauma) and quality of life will be assessed at pre- post and follow-up (after 3, 6 and 12 months). In addition, some symptoms of will be assessed daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological First Aid | Experimental | Behavioral: Psychological First AidPsychological material developed for children and adolescents, based on cognitive behavioral theory, used to structure therapeutic conversations and/or for self-help. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children/adolescents that:
- understand and speak Norwegian
Key exclusion criteria (5 listed)
- Children/adolescents with:
- mental retardation
- reading skills below 8 year
- psychosis
- high risk of suicidal behavior is assumed
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 |
|---|---|---|
| Psychological First AidA cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma | Behavioural | Psychological First Aid |
Primary outcome
Children's Revised Impact of Event Scale (CRIES)
Time frame: One year
1 secondary outcome
Child Post-Traumatic Cognition Inventory (CPTCI)
Time frame: One year
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 7 Dec 2015.
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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.
Bente SM Haugland, PhD principal investigator
Centre for Child and Adolescent Mental Health, Western Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychological First Aid in people with Post Traumatic Stress Disorder and Adjustment Disorder, run by NORCE Norwegian Research Centre AS at 1 site 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 6 inclusion and 5 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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) (time frame: One year). 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 7 Dec 2015.