InjuryNCT00296842
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial
A study testing Early psychological intervention in people with Injury, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Injury
- What is being tested?
- Early psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 99 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2004to Feb 2008
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay
Who cannot join
- severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital, Psychosomatic and Psychiatry
Zurich, CH-8032
About this study
Official title: Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial
The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents
Read the detailed description
Within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. After a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.
- Conditions
- Injury
- Being tested
- Early psychological intervention
- Keywords
- posttraumatic stress disorder, children, injury, road traffic accident
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early psychological interventionBehavioural
Psychoeducation, trauma narrative, provision of coping skills
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-CA
Measured: 10 days, 2 months, 6 months after intervention
CBCL
Measured: 10 days, 2 months, 6 months after intervention
DIKJ
Measured: 10 days, 2 months, 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startNov 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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 InjuryStudies 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
- 99 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296842
- Sponsor's protocol ID
- PICARTA-1
- Status last verified
- Dec 2011
- First submitted
- 24 Feb 2006
- Last updated
- 9 Dec 2011
- Results posted
- No
Publications
Zehnder D, Meuli M, Landolt MA. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2010 Feb 8;4:7. doi: 10.1186/1753-2000-4-7.
PubMed 20181120
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00296842
- Acronym / sponsor ID
- PICARTA-1
- Conditions
- Injury
- Keywords
- posttraumatic stress disorder, children, injury, road traffic accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Feb 2006 (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 study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents
Detailed description
Within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. After a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay
Key exclusion criteria (1 listed)
- severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness
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 interventionPsychoeducation, trauma narrative, provision of coping skills | Behavioural | – |
Primary outcome
CAPS-CA
Time frame: 10 days, 2 months, 6 months after intervention
CBCL
Time frame: 10 days, 2 months, 6 months after intervention
DIKJ
Time frame: 10 days, 2 months, 6 months after 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 9 Dec 2011.
- Results publication: PubMed 20181120Zehnder D, Meuli M, Landolt MA. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial. Child Adolesc Psychiatry Ment Health. 2010 Feb 8;4:7. doi: 10.1186/1753-2000-4-7.
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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
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 Injury, 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 1 inclusion and 1 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 9 Dec 2011. 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?
CAPS-CA (time frame: 10 days, 2 months, 6 months after intervention). The study lists 3 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 NCT00296842, 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 9 Dec 2011.