- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850407
Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?
February 1, 2014 updated by: Hackensack Meridian Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- consecutive caregivers accompanying children for scheduled sexual abuse medical examination
Exclusion Criteria:
- Lack of consent
- Failure to complete study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Education Counseling
Education of caregivers to counter lack of Preparedness for Children Undergoing Sexual Abuse Medical Examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination
Time Frame: one month
|
[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.
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nina Agrawal, MD, Hackensack Meridian Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
May 7, 2013
First Submitted That Met QC Criteria
May 7, 2013
First Posted (Estimate)
May 9, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 1, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 07.02.054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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