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

NCT02226393 | Terminated DMC

• 1 other identifier: RMC147804ctil
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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. 1.PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.
2. 2.PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents.
3. 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).

Conditions

Post-Traumatic Stress Disorder in Children

Keywords

Toddlers; Preschoolers; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Beck Depression Inventory (BDI)

  Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment

• 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

• Posttraumatic Stress Cognitions Inventory (PTCI)

  Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment

• 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

Study Arms (2)

Prolonged exposure

EXPERIMENTAL

See intervention description

Behavioral: Prolonged exposure

Child-parent Play Therapy

ACTIVE COMPARATOR

see intervention description

Behavioral: Child-parent Play Therapy

Interventions

Prolonged exposure 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.

Prolonged exposure

Child-parent Play Therapy 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.

Child-parent Play Therapy

Eligibility Criteria

• Age: 18 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
• Toddlers whose parents are living together

You may not qualify if:

• Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
• Toddlers with intelectual developmental disorder
• Toddlers with an active psychosis
• Toddlers with blindness or deafness
• Toddlers who are currently taking psychotropic medication
• Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms
• Toddlers diagnozed with autism spectrum disorder
• Toddlers who were exposed to domestic or sexual violence

Sponsors & Collaborators

• Association for Children at Risk: lead
• Geha Mental Health Center: collaborator

Study Sites (2)

Rabin medical center

Petah Tikva, Israel

Location

Association for Children at Risk's Cohen Harris Resilience Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Orit Krispin, Phd

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Lilach Rachamim, Phd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 27, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

IL (2)