Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01850407
First received: May 7, 2013
Last updated: February 1, 2014
Last verified: February 2014
  Purpose

Children are typically inadequately prepared for the sexual abuse medical examination. Caregivers report lack of examination knowledge as a barrier to preparing their children. The purpose of this study was to determine if informational leaflets provided prior to the examination are helpful to caregivers in preparing their children.


Condition Intervention
Child Sexual Abuse, Suspected
Behavioral: Education Counseling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?

Resource links provided by NLM:


Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination [ Time Frame: one month ] [ Designated as safety issue: No ]
    [The study] undertook a prospective study of consecutive caregivers accompanying children for a scheduled sexual abuse medical examination. Prior to the appointment, caregivers were mailed information leaflets (in English and Spanish) about how to prepare their children for the exam. Caregivers completed pre and post exam surveys and the State-Trait Anxiety Inventory.


Enrollment: 37
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Education Counseling
Education of caregivers to counter lack of Preparedness for Children Undergoing Sexual Abuse Medical Examination
Behavioral: Education Counseling

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consecutive caregivers accompanying children for scheduled sexual abuse medical examination

Exclusion Criteria:

  • Lack of consent
  • Failure to complete study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850407

Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Nina Agrawal, MD Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT01850407     History of Changes
Other Study ID Numbers: 07.02.054
Study First Received: May 7, 2013
Last Updated: February 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hackensack University Medical Center:
Lack of Preparation for Abused Children during Medical Examination

ClinicalTrials.gov processed this record on October 20, 2014