Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT02226393
Status:
TERMINATED
Last Update Posted:
2020-02-11
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment
Sponsor:
Association for Children at Risk
Organization:
Study Overview
Official Title:
Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: