Acute Stress DisorderPICARTA-BNCT01085370
Psychological Interventions in Children After Road Traffic Accidents or Burns
A study testing Early psychological intervention in people with Acute Stress Disorder, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Acute Stress Disorder
- What is being tested?
- Early psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2010to Aug 2013
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-16 years
- Glasgow Coma Scale (GCS) > 8
- German speaking
- Burn accident or road traffic accident
Who cannot join
- Glasgow Coma Scale (GCS) < 9
- more than 2 weeks in the Pediatric Intensive Care Unit
- no command of German
- previous mental retardation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Unviersity Children's Hospital, Psychosomatic and Psychiatry
Zurich, CH-8032
About this study
Official title: Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study
Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). During the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group. Participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument. After a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies. Both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.
- Conditions
- Acute Stress Disorder
- Being tested
- Early psychological intervention
- Keywords
- posttraumatic stress, prevention, children, acute stress disorder due to burn injury or injuries associated with road traffic accidents
- Medical subject headings
- Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early psychological interventionOther
3 modules: psychoeducation, reconstruction of the trauma, coping skills
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | standard medical care only |
| Intervention group | Experimental | 2 sessions with early psychological interventions Receives: Other: Early psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
Measured: Baseline, 3 months, 6 months post intervention
Secondary outcomes (3)
KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
Measured: Baseline, 3 months, 6 months post intervention
Child behavior Child Behavior Checklist (CBCL)
Measured: Baseline, 3 months, 6 months post intervention
Child Depression Inventory (CDI)
Measured: Baseline, 3 months, 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionAug 2013
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 Acute 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus A Landolt, PhD, Principal investigator, University Children's Hospital Zurich, Psychosomatic and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085370
- Sponsor's protocol ID
- PICARTA-B
- Acronym
- PICARTA-B
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2010
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer DN, Hertli MB, Landolt MA. Evaluation of an early risk screener for PTSD in preschool children after accidental injury. Pediatrics. 2013 Oct;132(4):e945-51. doi: 10.1542/peds.2013-0713. Epub 2013 Sep 23.
PubMed 24062371
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01085370
- Acronym / sponsor ID
- PICARTA-B / PICARTA-B
- Conditions
- Acute Stress Disorder
- Keywords
- posttraumatic stress, prevention, children, acute stress disorder due to burn injury or injuries associated with road traffic accidents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Mar 2010 (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.
Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). During the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group. Participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument. After a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies. Both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –standard medical care only |
| Intervention group | Experimental | Other: Early psychological intervention2 sessions with early psychological interventions |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2-16 years
- Glasgow Coma Scale (GCS) > 8
- German speaking
- Burn accident or road traffic accident
Key exclusion criteria (4 listed)
- Glasgow Coma Scale (GCS) < 9
- more than 2 weeks in the Pediatric Intensive Care Unit
- no command of German
- previous mental retardation
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 |
|---|---|---|
| Early psychological intervention3 modules: psychoeducation, reconstruction of the trauma, coping skills | Other | Intervention group |
Primary outcome
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)
Time frame: Baseline, 3 months, 6 months post intervention
3 secondary outcomes
KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)
Time frame: Baseline, 3 months, 6 months post intervention
Child behavior Child Behavior Checklist (CBCL)
Time frame: Baseline, 3 months, 6 months post intervention
Child Depression Inventory (CDI)
Time frame: Baseline, 3 months, 6 months post intervention
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 18 Mar 2014.
- Derived from this study: PubMed 24062371Kramer DN, Hertli MB, Landolt MA. Evaluation of an early risk screener for PTSD in preschool children after accidental injury. Pediatrics. 2013 Oct;132(4):e945-51. doi: 10.1542/peds.2013-0713. Epub 2013 Sep 23.
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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.
Markus A Landolt, PhD principal investigator
University Children's Hospital Zurich, Psychosomatic and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early psychological intervention in people with Acute Stress Disorder, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 4 inclusion and 4 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 18 Mar 2014. 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 Switzerland. 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?
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI) (time frame: Baseline, 3 months, 6 months post intervention). 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 NCT01085370, 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 18 Mar 2014.