Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment

NCT ID: NCT02226393

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-09-30

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).

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

Post-Traumatic Stress Disorder in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolonged exposure

See intervention description

Group Type: EXPERIMENTAL

Prolonged exposure

Intervention Type: BEHAVIORAL

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.

Child-parent Play Therapy

see intervention description

Group Type: ACTIVE_COMPARATOR

Child-parent Play Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment

2. Toddlers whose parents are living together

Exclusion Criteria

1. Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.

2. Toddlers with intelectual developmental disorder

3. Toddlers with an active psychosis

4. Toddlers with blindness or deafness

5. Toddlers who are currently taking psychotropic medication

6. Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms

7. Toddlers diagnozed with autism spectrum disorder

8. Toddlers who were exposed to domestic or sexual violence

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 66 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geha Mental Health Center

OTHER

Sponsor Role: collaborator

Association for Children at Risk

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orit Krispin, Phd

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center, Israel

Lilach Rachamim, Phd

Role: STUDY_DIRECTOR

Locations

Rabin medical center

Petah Tikva, , Israel

Association for Children at Risk's Cohen Harris Resilience Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

RMC147804ctil

Identifier Type: -

Identifier Source: org_study_id