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Post-Traumatic Stress DisorderNCT00447538

Posttraumatic Symptoms Among Toddlers and Their Parents Following Exposure to Terrorism

An observational study of Post-Traumatic Stress Disorder, run by Herzog Hospital at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are: 1. Identifying young children (under 6 years old) and their parents who are suffering from posttraumatic distress in the aftermath of the continuing conflict on Gaza border… Read more about this study

Who is it for?
Ages 24 to 48 monthsHealthy volunteers can take part
Conditions the study is for
Post-Traumatic Stress Disorder
How many people
300 participants
Where
1 siteIsrael
Study dates
Nov 2005to Jan 2007
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 24 to 48 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Families with children between 24-48
  • Families living in Sderot, Israel

Who cannot join

  • Children with severe developmental problems

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Sderot

    Sderot

Other trials in Israel

About this study

Official title: Identifying Distress, Developmental and Behavioral Problems Among Toddlers, and Posttraumatic Distress Among Their Parents Following Continuous Exposure to Terrorism

The project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are:

  1. Identifying young children (under 6 years old) and their parents who are suffering from posttraumatic distress in the aftermath of the continuing conflict on Gaza border, Israel.
  2. Increasing the capacity of local institutions to treat toddlers and families at risk.
  3. Providing resilience -building services that strengthen the coping abilities of families and caregivers in response to continual terrorism.
Read the detailed description

This project's aim is to identify psychological distress, build resilience among toddlers and their parents, and treat post traumatic stress disorder. The project components have consisted of a) using resilience-building interventions geared toward helping parents and daycare teachers deal with the stress engendered by the repeated emergency situations b) screening toddlers (24-48 months) for post traumatic distress utilizing new validated instruments c) referring highly symptomatic children and parents to dyadic treatment which focuses on observing the dynamics and interaction between parents and children before treatment intervention with the (more typically) mother/child.

Research into childhood trauma has clearly demonstrated that infants and children impacted by terrorism or with mothers who have suffered traumatic experiences are at very high risk for a multitude of long-term emotional disorders. Mothers suffering the effects of Post Traumatic Stress Disorders (PTSD) have difficulty providing the emotional holding environment and relational foundation necessary for healthy attachment and bonding. An anxious or traumatized mother will have difficulty soothing her child if she herself is in a state of emotional and physical hyper-arousal.

The project is aimed at identifying children who are suffering from posttraumatic distress and increasing capacity to provide treatment for them and for their caretakers. The project will be implemented in Sderot. Professional staff (teachers, nurses and aides) will be trained to conduct a systematic short screening in order to identify families with babies, toddlers and young children suffering from, or at risk for post-traumatic stress disorder.

The elements of the project will consist of:

  1. Screening of young children and implementation of treatment The screening will consist of a short interviews with parents conducted by trained professional about exposure to traumatic events and resulting post-traumatic specific symptoms among the toddlers and their parents.
  2. Workshops for parents, teachers, nurses The knowledge and skills of preschool teachers and nurses working in all our projects sights as well as parents will be increased by providing training regarding the impact of war related trauma on preschool children. Workshops will better equip teachers, nurses and parents with knowledge about the emotional impact of trauma on young children and will increase the skills to help preschool children contain emotional distress as well as to help them in coping with the emotional consequences of trauma exposure.
  3. Treatment Interventions Dyadic treatment involving parents and children is aimed at increasing the attunement of parents to their toddlers and their needs in times of crises. Local practitioners in Sderot will received specialized training in this methodology by a child trauma specialist from Mount Sinai Medical Center in New York. The effectiveness of the dyadic treatment will be evaluated.
  4. Evaluation of treatment Evaluation of treatment efficacy (dyadic treatment) will be assessed by pre and post interviews that will be conducted by trained professionals with all parents participating in the dyadic treatments in each of the three cities.
Medical subject headings
Stress Disorders, Post-Traumatic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2007 (estimated)
  2. Study startNov 2005
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447538
Sponsor's protocol ID
Rpat1CTIL
Status last verified
Apr 2013
First submitted
13 Mar 2007
Last updated
30 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Post-Traumatic Stress Disorder, run by Herzog Hospital 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 2 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: finished, as of the sponsor's last update on 30 Apr 2013. 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?

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.

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 30 Apr 2013.

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