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

Association for Children at Risk

Status: Terminated

Conditions: Post-Traumatic Stress Disorder in Children

Treatments: Behavioral: Prolonged exposure; Behavioral: Child-parent Play Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02226393

RMC147804ctil

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 66 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Prolonged exposure

Experimental group

Description:

See intervention description

Treatment:

Behavioral: Prolonged exposure

Child-parent Play Therapy

Active Comparator group

Description:

see intervention description

Treatment:

Behavioral: Child-parent Play Therapy