Acute Post-Traumatic Stress DisorderPhase 2NCT00974467
Evaluating a Website for Parents of Injured Children
A Phase 2 study testing After The Injury website in people with Acute Post-Traumatic Stress Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Acute Post-Traumatic Stress Disorder
- What is being tested?
- After The Injury website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2011
- Phase
- Phase 2
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
- Have access to the Internet at home (for Stage 3 only)
Who cannot join
- Parent does not read or understand English
- Child's injury is due to participation in organized sports
- Child's injury is due to suspected abuse or family violence
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.
Read the detailed description
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.
- Conditions
- Acute Post-Traumatic Stress Disorder
- Being tested
- After The Injury website, Control
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After The Injury websiteBehavioural
Parents participate in a web-based prevention intervention, which provides education and tips specific to coping with a child's injury.
ControlOther
Usual hospital care provided.
| Study group | Role | What they receive |
|---|---|---|
| After The Injury website | Experimental | Not described Receives: Behavioral: After The Injury website |
| Usual care | Other | Treatment as usual Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on measure of parent knowledge re: traumatic stress and coping assistance.
Measured: 6 wks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Kassam-Adams, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974467
- Sponsor's protocol ID
- 2008-4-5932
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2009
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Website for Parents of Injured Children
- ClinicalTrials.gov ID
- NCT00974467
- Acronym / sponsor ID
- 2008-4-5932
- Conditions
- Acute Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Sep 2009 (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 the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.
Detailed description
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After The Injury website | Experimental | Behavioral: After The Injury website |
| Usual care | Other | Other: ControlTreatment as usual |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
- Have access to the Internet at home (for Stage 3 only)
Key exclusion criteria (3 listed)
- Parent does not read or understand English
- Child's injury is due to participation in organized sports
- Child's injury is due to suspected abuse or family violence
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 |
|---|---|---|
| After The Injury websiteParents participate in a web-based prevention intervention, which provides education and tips specific to coping with a child's injury. | Behavioural | After The Injury website |
| ControlUsual hospital care provided. | Other | Usual care |
Primary outcome
Scores on measure of parent knowledge re: traumatic stress and coping assistance.
Time frame: 6 wks 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 12 Mar 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.
Nancy Kassam-Adams, Ph.D. principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing After The Injury website in people with Acute Post-Traumatic Stress Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
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 2 inclusion and 3 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 12 Mar 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Scores on measure of parent knowledge re: traumatic stress and coping assistance. (time frame: 6 wks post-intervention). 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 12 Mar 2015.