Pharmacologic Treatment of PTSD in Sexually Abused Children

Study Overview
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Brief Summary
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This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Detailed Description
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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.

Official Title
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Pharmacologic Treatment of PTSD in Sexually Abused Children

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Trauma-Focused Cognitive Behavioral Therapy
* Drug: Sertraline Pill
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion: Ages 10-17 years, inclusive Confirmed sexual abuse At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal) Parent/primary caregiver available to participate in treatment Assent with parental consent to participate Exclusion: Non-English speaking schizophrenia or other severe psychotic disorder MR (IQ<60) or PDD preventing CBT treatment taking current psychotropic medication documented substance dependence (substance abuse allowed)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TF-CBT + sertraline<br>Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day | Behavioral: Trauma-Focused Cognitive Behavioral Therapy<br>* 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent<br>Drug: Sertraline Pill<br>* 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT<br>|
| Active Comparator: TF-CBT +placebo<br>Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline) | Drug: Sertraline Pill<br>* 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT<br>Drug: Placebo Oral Tablet<br>* 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD | Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study. | Up to 39 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms | Change in depressive symptoms as determined by change in score | Up to 39 months | 
| Anxiety Symptoms | Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the clinical symptom present at enrollment category were tested to see if their status changed during the trial. | Up to 39 months | 
| Global Impairment | Change in Children's Global Assessment Scale (CGAS) between the two groups | Up to 39 months | 
| Incidence of Suicidality | Change in degree of suicidal ideation during study | Up to 39 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Anxiety