Completed

Treatment of PTSD in Sexually Abused Children

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What is being tested

Trauma-Focused CBT

+ Child-Centered Therapy

Behavioral
Who is being recruted

Trauma and Stressor Related Disorders+4

+ Behavior

+ Mental Disorders

From 8 to 14 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTreatment of PTSD in Sexually Abused Children
R10MH055963NCT00000383
Principal SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

229 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Trauma and Stressor Related DisordersBehaviorMental DisordersCoitusSexual BehaviorStress Disorders, Post-TraumaticStress Disorders, Traumatic

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Trauma -Focused CBT provides 12 sessions (45 minutes child, 45 minutes parent) of CBT treatment. This includes therapist-directed trauma-focused skills training, exposure, parenting, conjoint parent-child sessions, and safety component provided to child and parent.

Group II

Active Comparator
Child Centered Therapy provides 12 sessions (45 minutes child, 45 minutes parent) of supportive interventions. This includes client-directed activities focused on the needs and interests of the child or parent, respectively.

Study 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

Suspended

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 Maps
Suspended

Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents

Pittsburgh, United States
Suspended

Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital

Pittsburgh, United States
Completed3 Study Centers
Treatment of PTSD in Sexually Abused Children | PatLynk