The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures, treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the effectiveness of SC-TF-CBT for early childhood PTSD.
Young children who are exposed to traumatic events such as abuse, disasters, accidents, illnesses, injury and the death of a person close to them are at risk for developing PTSD. While effective treatments for childhood PTSD exist, novel interventions that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The purpose of this study is to develop and test the feasibility of an intervention called Stepped Care Trauma-Focused Cognitive Behavioral Therapy which has the potential to greatly improve service delivery approaches to make treatment more accessible and less costly, thereby reducing childhood PTSD and related societal impacts and costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Stepped Care TF-CBT patients will receive step one: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the National Child Traumatic Stress Network website (via web or paper for those without access). Children who do not meet responder status will receive step two: 9 (1 to 1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks.
Standard TF-CBT patients will receive 12 (1 to 1.5 hr.) standard weekly in-office therapist-directed sessions over 12 to 14 weeks (Phase II only). The 2 additional weeks allow for scheduling difficulty. Standard TF-CBT includes child, parent and conjoint parent-child sessions addressing the core trauma treatment components discussed in section a.3 (e.g. stress management, skill building, gradual exposure, \& trauma narrative etc.).
Crisis Center of Tampa Bay
Tampa, Florida, United States
Posttraumatic stress symptoms
Change from baseline in Diagnostic Preschool Infant Assessment PTSD module (DIPA; Scheeringa, 2010) and in the Trauma Symptom Checklist for Young Children (Briere et al., 2001) at 14 weeks and 3 month follow up
Time frame: baseline, week 14, and 3 month follow up
Externalizing behaviors
Change from baseline in the Child Behavior Checklist (Achenbach \& Rescorla, 2000) externalizing behaviors at 14 weeks and 3 month follow up
Time frame: baseline and week 14 and 3 month follow up
Internalizing behaviors
Change from baseline in the Child Behavior Checklist (Achenbach \& Rescorla, 2000) internalizing behaviors at week 14 and 3 month follow up
Time frame: baseline, week 14 and 3 month follow up
Independent Evaluator-rated PTSD symptom and impairment severity
Change from baseline in clinical global impression severity (NIMH, 1985)at week 14 and 3 month follow up
Time frame: baseline, week 14 and 3 month follow up
Global improvement
Change from baseline in clinical global impression - improvement (Guy, 1976)at week 14 and 3 month follow up
Time frame: baseline, week 14 and 3 month follow up
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