Phase 3
N=24
Pharmacologic Treatment of PTSD in Sexually Abused Children
Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT00078767 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD — 8; 6; 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trauma-Focused Cognitive Behavioral Therapy (Behavioral); Sertraline Pill (Drug); Placebo Oral Tablet (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD |
8; 6; 1; 5; 2; 0 | — |
| SECONDARY Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms |
8; 5; 3; 6 | — |
| SECONDARY Anxiety Symptoms |
8; 5; 2; 2; 1; 4 | — |
| SECONDARY Global Impairment |
9; 6; 2; 5 | — |
| SECONDARY Incidence of Suicidality |
4; 1; 0; 0; 7; 10 | — |
Summary
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00078767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.