Child Sexual Abuse, SuspectedNCT01850407
Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?
A study testing Education Counseling in people with Child Sexual Abuse, Suspected, run by Hackensack Meridian Health.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse, Suspected
- What is being tested?
- Education Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consecutive caregivers accompanying children for scheduled sexual abuse medical examination
Who cannot join
- Lack of consent
- Failure to complete study
About this study
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.
- Conditions
- Child Sexual Abuse, Suspected
- Being tested
- Education Counseling
- Keywords
- Lack of Preparation for Abused Children during Medical Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Education Counseling | No intervention | Education of caregivers to counter lack of Preparedness for Children Undergoing Sexual Abuse Medical Examination Receives: Behavioral: Education Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination
[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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Sexual Abuse, SuspectedStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Agrawal, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850407
- Sponsor's protocol ID
- 07.02.054
- Status last verified
- Feb 2014
- First submitted
- 7 May 2013
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Caregivers for the Child Sexual Abuse Examination: Are Informational Leaflets Helpful?
- ClinicalTrials.gov ID
- NCT01850407
- Acronym / sponsor ID
- 07.02.054
- Conditions
- Child Sexual Abuse, Suspected
- Keywords
- Lack of Preparation for Abused Children during Medical Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 May 2013 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education Counseling | No intervention | Behavioral: Education CounselingEducation of caregivers to counter lack of Preparedness for Children Undergoing Sexual Abuse Medical Examination |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive caregivers accompanying children for scheduled sexual abuse medical examination
Key exclusion criteria (2 listed)
- Lack of consent
- Failure to complete study
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 |
|---|---|---|
| Education Counseling | Behavioural | Education Counseling |
Primary outcome
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.
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 Feb 2014.
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.
Nina Agrawal, MD principal investigator
Hackensack Meridian Health
Questions about this trial
What is this clinical trial studying?
A study testing Education Counseling in people with Child Sexual Abuse, Suspected, run by Hackensack Meridian Health.
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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the helpfulness of informational leaflets in preparing caregivers for the child sex abuse examination (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2014.