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

Not Applicable

Terminated

• Conditions: Post-Traumatic Stress Disorder in Children
• Interventions: Behavioral: Prolonged exposure; Behavioral: Child-parent Play Therapy

• Registration Number: NCT02226393
• Lead Sponsor: Association for Children at Risk

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.

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Study Start: 2014-10
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged exposure	Prolonged exposure	See intervention description
Child-parent Play Therapy	Child-parent Play Therapy	see intervention description

Primary Outcome Measures

Name	Time	Method
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).	Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment	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.

Secondary Outcome Measures

Name	Time	Method
The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)	Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment	A self report questionnaire for the assessment of PTSD symptoms among adults
Posttraumatic Stress Cognitions Inventory (PTCI)	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment	A self report questionnaire assessing post traumatic beliefs in adults
Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment	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".
Beck Depression Inventory (BDI)	Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment	A self-report questionnaire for depression among adults

Trial Locations

Locations (2)

Rabin medical center; 🇮🇱 Petah-Tikva, Israel

Association for Children at Risk's Cohen Harris Resilience Center; 🇮🇱 Tel Aviv, Israel