Pharmacologic Treatment of PTSD in Sexually Abused Children
Trauma-Focused Cognitive Behavioral Therapy
+ Sertraline Pill
+ Placebo Oral Tablet
Trauma and Stressor Related Disorders+1
+ Mental Disorders
+ Stress Disorders, Post-Traumatic
Treatment Study
Summary
Study start date: April 1, 2001
Actual date on which the first participant was enrolled.Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion: 1. Ages 10-17 years, inclusive 2. Confirmed sexual abuse 3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal) 4. Parent/primary caregiver available to participate in treatment 5. Assent with parental consent to participate Exclusion: 1. Non-English speaking 2. schizophrenia or other severe psychotic disorder 3. MR (IQ\<60) or PDD preventing CBT treatment 4. taking current psychotropic medication 5. documented substance dependence (substance abuse allowed)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, United StatesSee the location