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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

TypeNameDescription
BEHAVIORALProlonged exposureThe 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.
BEHAVIORALChild-parent Play TherapyIs 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.

Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment (NCT02226393) · Clinical Trials Directory