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Completed

NCT Number: NCT00078767

Pharmacologic Treatment of PTSD in Sexually Abused Children

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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Key information

Conditions

Stress Disorders, Post-Traumatic Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents

Pittsburgh, Pennsylvania, 15212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trauma-Focused Cognitive Behavioral Therapy

Behavioral

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

Sertraline Pill

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  1. Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD

    Time frame: Up to 39 months

    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.

Secondary outcomes

  1. Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms

    Time frame: Up to 39 months

    Change in depressive symptoms as determined by change in score

  2. Anxiety Symptoms

    Time frame: Up to 39 months

    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.

  3. Global Impairment

    Time frame: Up to 39 months

    Change in Children's Global Assessment Scale (CGAS) between the two groups

  4. Incidence of Suicidality

    Time frame: Up to 39 months

    Change in degree of suicidal ideation during study

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Mar 8, 2004
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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