Clinical trial NCT02226393: Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment
Official title: Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Children
Keywords: Toddlers; Preschoolers; PTSD
Lead sponsor: Association for Children at Risk
Sponsor class: OTHER
Collaborators: name: Geha Mental Health Center
First posted: 2014-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
timeFrame: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
measure: The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)
timeFrame: Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
measure: Posttraumatic Stress Cognitions Inventory (PTCI)
timeFrame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
measure: Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)
timeFrame: Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin medical center
city: Tel Aviv
country: Israel
facility: Association for Children at Risk's Cohen Harris Resilience Center
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Orit Krispin, Phd
role: PRINCIPAL_INVESTIGATOR
name: Lilach Rachamim, Phd
role: STUDY_DIRECTOR
References: