Pharmacologic Treatment of PTSD in Sexually Abused Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-03-31

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).

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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.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TF-CBT + sertraline

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

Group Type EXPERIMENTAL

Trauma-Focused Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent

Sertraline Pill

Intervention Type DRUG

12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT

TF-CBT +placebo

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)

Group Type ACTIVE_COMPARATOR

Sertraline Pill

Intervention Type DRUG

12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT

Placebo Oral Tablet

Intervention Type DRUG

12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Interventions

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Trauma-Focused Cognitive Behavioral Therapy

12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent

Intervention Type BEHAVIORAL

Sertraline Pill

12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT

Intervention Type DRUG

Placebo Oral Tablet

12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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)

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No