Post Traumatic Stress DisorderNCT01656655
Effect of Post Traumatic Stress Disorder on Parenting
An observational study of Post Traumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family relationships. This study will examine some of the effects on parenting, from the perspective of the parent with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Jun 2013
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with ptsd
Who may be able to join
- ptsd (PSS>15) children under age 18
Who cannot join
- non ptsd (pss<15) children under age 18
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, Choose A State, 92200
Sara Freedman, PhD, 972544704636, sarafreedman@gmail.com
Rena Cooper, MD, crena@hadassah.org.il
About this study
Official title: Parenting With and Without PTSD: The Effect of Attachment, Symptoms and Posttraumatic Growth
PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family relationships. This study will examine some of the effects on parenting, from the perspective of the parent with PTSD.
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- ptsd, parenting
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PTSD group | Patients with PTSD | |
| Control Group | non PTSD group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hillel Yaffe Medical Center
- Responsible party
- Principal investigator, Rena Cooper, Hadassah Medical Organization
- Investigators
- rena Cooper, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656655
- Sponsor's protocol ID
- PTSDpar-2-hmo
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting With and Without PTSD: The Effect of Attachment, Symptoms and Posttraumatic Growth
- ClinicalTrials.gov ID
- NCT01656655
- Acronym / sponsor ID
- PTSDpar-2-hmo
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- ptsd, parenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hillel Yaffe Medical Center
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Aug 2012 (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.
PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family relationships. This study will examine some of the effects on parenting, from the perspective of the parent with PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD group | – | –Patients with PTSD |
| Control Group | – | –non PTSD group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ptsd
Key inclusion criteria (1 listed)
- ptsd (PSS>15) children under age 18
Key exclusion criteria (1 listed)
- non ptsd (pss<15) children under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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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.
rena Cooper, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rena Cooper, MD (972544704636, crena@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 Aug 2012.