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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 20, 2005 | ||||||||
| Last Updated Date | May 3, 2006 | ||||||||
| Start Date ICMJE | January 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Acceptability, perceived safety and ease of administration of each survey method | ||||||||
| Original Primary Outcome Measures ICMJE |
1. Acceptability, perceived safety and ease of administration of each survey method. | ||||||||
| Change History | Complete list of historical versions of study NCT00122395 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Disclosure of domestic violence | ||||||||
| Original Secondary Outcome Measures ICMJE |
1. Disclosure of domestic violence | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial Regarding the Acceptability of Audiotape Intimate Partner Violence (IPV) Screening | ||||||||
| Official Title ICMJE | A Randomized Clinical Trial Regarding the Acceptability of an Audiotape Questionnaire for Intimate Partner Violence Screening in a Pediatric ED | ||||||||
| Brief 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). |
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| 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:
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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Domestic Violence | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 500 | ||||||||
| Completion Date | March 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00122395 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 2004-5-3793 | ||||||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||||||
| Verification Date | July 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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