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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00122395
Other study ID # 2004-5-3793
Secondary ID
Status Completed
Phase N/A
First received July 20, 2005
Last updated May 3, 2006
Start date January 2005
Est. completion date March 2005

Study information

Verified date July 2005
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Older than 18 or an emancipated minor

Exclusion Criteria:

- Child undergoing acute resuscitation

- Other adults in the room

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Screening via pen and paper

Screening via audiotape


Locations

Country Name City State
United States The Children's Hospital of Philadelphia Emergency Department Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability, perceived safety and ease of administration of each survey method
Secondary Disclosure of domestic violence
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