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

Post-Traumatic Stress Disorder in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02226393
• Other study ID #: RMC147804ctil
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2019

Study information

• Verified date: February 2020
• Source: Association for Children at Risk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 66 Months

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder in Children
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah-Tikva
Israel	Association for Children at Risk's Cohen Harris Resilience Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Association for Children at Risk	Geha Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).	Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa & Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.	Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Secondary	Beck Depression Inventory (BDI)	A self-report questionnaire for depression among adults	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Secondary	The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)	A self report questionnaire for the assessment of PTSD symptoms among adults	Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Secondary	Posttraumatic Stress Cognitions Inventory (PTCI)	A self report questionnaire assessing post traumatic beliefs in adults	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Secondary	Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)	The Parenting Sense of Competency Scale (PSOC) was developed by Gibaud-Wallston as part of her PhD dissertation and presented at the American Psychological Association by Gibaud-Wallston and Wandersman in 1978. The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment