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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00447538
Other study ID # Rpat1CTIL
Secondary ID
Status Completed
Phase Phase 4
First received March 13, 2007
Last updated April 29, 2013
Start date November 2005
Est. completion date January 2007

Study information

Verified date April 2013
Source Herzog Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 24 Months to 48 Months
Eligibility Inclusion Criteria:

- Families with children between 24-48

- Families living in Sderot, Israel

Exclusion Criteria:

- Children with severe developmental problems

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
Israel Sderot Sderot

Sponsors (2)

Lead Sponsor Collaborator
Herzog Hospital Picower Foundation

Country where clinical trial is conducted

Israel, 

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