Treatment of PTSD in Sexually Abused Children
Trauma-Focused CBT
+ Child-Centered Therapy
Trauma and Stressor Related Disorders+4
+ Behavior
+ Mental Disorders
Treatment Study
Summary
Study start date: September 1, 1997
Actual date on which the first participant was enrolled.To evaluate the comparative efficacy of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT) in decreasing symptoms of Post-Traumatic Stress Disorder (PTSD) following recent sexual abuse. Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related and general psychopathological symptoms. Patients are randomly assigned to receive either TF-CBT or CCT at each of two sites, and will be provided with 12 weeks of individual therapy for children and parents. Treatment is monitored for compliance with the respective treatment models through intensive supervision, audiotaping of sessions, rating of sessions with use of adherence checklists, and independent blind rating of audiotapes. Treatment outcome is evaluated through the use of several self-, parent-, and teacher-report standardized instruments, administered at pre- and post-treatment, and follow-up evaluations at 6 and 12 months. The project also assesses differential treatment impact by gender and ethnicity, and attempts to evaluate the impact of specific components of the treatment process in mediating treatment outcome. Specifically, the project evaluates the differential effectiveness of the two treatment modalities in improving the subject's abuse-related attributions and perceptions, parenting practices, familial adaptability and cohesiveness, parent support, and parental emotional reaction to the abuse, and the impact of improving these variables on treatment outcome.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.229 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 8 to 14 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 Criteria: \- Patients must have: 1. Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse 2. Confirmed child sexual abuse history 3. Speak English 4. Parent willing to participate in treatment Exclusion Criteria: 1. Active psychotic disorder resulting in inability to participate in CBT 2. Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT 4\) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
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 3 locations
Center for Children's Support, University of Medicine and Dentistry - New Jersey
Stratford, United StatesOpen Center for Children's Support, University of Medicine and Dentistry - New Jersey in Google MapsAllegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, United StatesCenter for Traumatic Stress in Children & Adolescents, Allegheny General Hospital
Pittsburgh, United States