Domestic ViolenceNCT00122395
Trial Regarding the Acceptability of Audiotape Intimate Partner Violence (IPV) Screening
A study testing Screening via pen and paper and Screening via audiotape in people with Domestic Violence, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ED). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Screening via pen and paper and Screening via audiotape
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2005
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 or an emancipated minor
Who cannot join
- Child undergoing acute resuscitation
- Other adults in the room
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia Emergency Department
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Clinical Trial Regarding the Acceptability of an Audiotape Questionnaire for Intimate Partner Violence Screening in a Pediatric ED
The purpose of this study is to compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ED).
Read the detailed description
Intimate partner violence (IPV) is a significant health problem, affecting 2 - 4 million women each year. Over half of the homes in which women are abused contain children, with 3.3 - 10 million children witnessing IPV each year. In 1998, the American Academy of Pediatrics (AAP) issued guidelines stating that "identifying and intervening on behalf of battered women may be one of the most effective means of preventing child abuse," and recommending that pediatricians perform routine IPV screening. Because of the substantial number of families seen in the emergency department (ED), this setting could provide an important site in which to implement universal screening. Exactly how to implement screening in this busy environment is unclear. One possible approach involves the use of an audiotape with a headset with a prerecorded screening questionnaire that prompts the respondent to circle "yes" or "no" answers on an otherwise blank sheet of paper. This method of screening has the potential benefits of:
- Providing a more private method of screening;
- Improving screening of women who cannot read well;
- Enhancing the rate of screening by removing the burden of screening from providers.
Comparison: Female caregivers in a pediatric ED will be randomized to answering domestic violence (DV) screening questions either via pen and paper or via audiotape. After answering these screening questions, all women will be asked standardized questions about the acceptability, safety and ease of use of the method to which they are randomized.
- Conditions
- Domestic Violence
- Being tested
- Screening via pen and paper, Screening via audiotape
- Keywords
- Domestic violence, Screening, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening via pen and paperBehavioural
Screening via audiotapeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability, perceived safety and ease of administration of each survey method
Secondary outcomes (1)
Disclosure of domestic violence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2005
- Study completionMar 2005
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 Domestic ViolenceStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Investigators
- Megan H Bair-Merritt, Principal investigator, Children's Hospital of PhiladelphiaJoel A Fein, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122395
- Sponsor's protocol ID
- 2004-5-3793
- Status last verified
- Jul 2005
- First submitted
- 20 Jul 2005
- Last updated
- 4 May 2006
- Results posted
- No
Publications
Bair-Merritt MH, Feudtner C, Mollen CJ, Winters S, Blackstone M, Fein JA. Screening for intimate partner violence using an audiotape questionnaire: a randomized clinical trial in a pediatric emergency department. Arch Pediatr Adolesc Med. 2006 Mar;160(3):311-6. doi: 10.1001/archpedi.160.3.311.
PubMed 16520452
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Regarding the Acceptability of an Audiotape Questionnaire for Intimate Partner Violence Screening in a Pediatric ED
- ClinicalTrials.gov ID
- NCT00122395
- Acronym / sponsor ID
- 2004-5-3793
- Conditions
- Domestic Violence
- Keywords
- Domestic violence, Screening, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Mar 2005
- First posted
- 22 Jul 2005 (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 compare the safety, acceptability and ease of the administration of two screening methods, a pen and paper questionnaire and an audiotape with headsets, for screening for intimate partner violence in a pediatric emergency department (ED).
Detailed description
Intimate partner violence (IPV) is a significant health problem, affecting 2 - 4 million women each year. Over half of the homes in which women are abused contain children, with 3.3 - 10 million children witnessing IPV each year. In 1998, the American Academy of Pediatrics (AAP) issued guidelines stating that "identifying and intervening on behalf of battered women may be one of the most effective means of preventing child abuse," and recommending that pediatricians perform routine IPV screening. Because of the substantial number of families seen in the emergency department (ED), this setting could provide an important site in which to implement universal screening. Exactly how to implement screening in this busy environment is unclear. One possible approach involves the use of an audiotape with a headset with a prerecorded screening questionnaire that prompts the respondent to circle "yes" or "no" answers on an otherwise blank sheet of paper. This method of screening has the potential benefits of:
- Providing a more private method of screening;
- Improving screening of women who cannot read well;
- Enhancing the rate of screening by removing the burden of screening from providers.
Comparison: Female caregivers in a pediatric ED will be randomized to answering domestic violence (DV) screening questions either via pen and paper or via audiotape. After answering these screening questions, all women will be asked standardized questions about the acceptability, safety and ease of use of the method to which they are randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 18 or an emancipated minor
Key exclusion criteria (2 listed)
- Child undergoing acute resuscitation
- Other adults in the room
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 |
|---|---|---|
| Screening via pen and paper | Behavioural | – |
| Screening via audiotape | Behavioural | – |
Primary outcome
Acceptability, perceived safety and ease of administration of each survey method
1 secondary outcome
Disclosure of domestic violence
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 4 May 2006.
- Results publication: PubMed 16520452Bair-Merritt MH, Feudtner C, Mollen CJ, Winters S, Blackstone M, Fein JA. Screening for intimate partner violence using an audiotape questionnaire: a randomized clinical trial in a pediatric emergency department. Arch Pediatr Adolesc Med. 2006 Mar;160(3):311-6. doi: 10.1001/archpedi.160.3.311.
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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.
Megan H Bair-Merritt principal investigator
Children's Hospital of Philadelphia
Joel A Fein 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 study testing Screening via pen and paper and Screening via audiotape in people with Domestic Violence, 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 1 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 4 May 2006. 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.
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?
Acceptability, perceived safety and ease of administration of each survey method. 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 NCT00122395, 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 4 May 2006.