Posttraumatic Symptoms Among Toddlers and Their Parents Following Exposure to Terrorism
| Tracking Information | |||||
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| First Received Date ICMJE | March 13, 2007 | ||||
| Last Updated Date | April 29, 2013 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00447538 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Posttraumatic Symptoms Among Toddlers and Their Parents Following Exposure to Terrorism | ||||
| Official Title ICMJE | Identifying Distress, Developmental and Behavioral Problems Among Toddlers, and Posttraumatic Distress Among Their Parents Following Continuous Exposure to Terrorism | ||||
| Brief Summary | The project utilize experience and knowledge gained from previous early childhood projects in NYC post 9/11 and Sderot. The overall goals are:
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| 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: A. 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. B. 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. C. 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. D. 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Post-Traumatic Stress Disorder | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 24 Months to 48 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00447538 | ||||
| Other Study ID Numbers ICMJE | Rpat1CTIL | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Herzog Hospital | ||||
| Collaborators ICMJE | Picower Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Herzog Hospital | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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