Trials / Terminated
TerminatedNCT02226393
Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment
Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Association for Children at Risk · Academic / Other
- Sex
- All
- Age
- 18 Months – 66 Months
- Healthy volunteers
- Not accepted
Summary
Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. It has not yet been tested in toddlers. The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with PTSD and their parents. A randomized control trial could examine the efficacy of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group. Our research hypotheses are: 1. PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers. 2. PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents. 3. These results will be preserved in a follow-up of 3-6 months post treatment. Following psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50 participants in each group).
Detailed description
Beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Prolonged exposure | The PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage. |
| BEHAVIORAL | Child-parent Play Therapy | Is consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2019-09-01
- Completion
- 2019-09-01
- First posted
- 2014-08-27
- Last updated
- 2020-02-11
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02226393. Inclusion in this directory is not an endorsement.