Stepped Care for Young Children After Trauma

Completed · Phase 1/Phase 2

Conditions studied: Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT01603563

Run by

University of South Florida

People needed

63

Starts

2011-07-01

Expected to finish

2014-11-01

Last updated by the study team

2015-04-24

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Child must have experienced at least one traumatic event after the age of 36 months.
• At least five Postttraumatic stress symptoms with one symptom of reexperiencing or one symptom of avoidance.
• Child must be between 3 and 7 years of age at the time of enrollment.
• The parent must be willing and able to participate in the treatment and complete informed consent.

You may not qualify if…

• Psychosis, mental retardation, autism, or related pervasive developmental disorders in child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions.
• Parent has had substance use disorder within the past 3 months.
• Child or parent is suicidal (the DIPA will be used to screen for child suicidal ideation and the SCID-RV will be used to screen for parent suicide ideation; assessed by all available information). A delayed entry once the parent or child is stabilized (at least 6 months post suicidal) and not having suicidal ideation will be allowed.
• Child or parent is not fluent in English.
• Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
• Child is receiving trauma-focused psychotherapy when study treatment is provided.
• Parent or caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home (e.g. mother's boyfriend, sibling).

Where it is running

• Crisis Center of Tampa Bay — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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