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Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children

Treatment of PTSD in Sexually Abused Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000383
Enrollment
229
Registered
1999-11-03
Start date
1997-09-30
Completion date
2002-09-30
Last updated
2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

Adolescence, Child, Cognitive Therapy, Comparative Study, Female, Human, Male, Stress Disorders, Post-Traumatic, Child Abuse, Sexual, Stress Disorders, Post-Traumatic -- *therapy, Child Abuse, Sexual -- *psychology

Brief summary

The purpose of this study is to compare the effectiveness of two psychological therapies used to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT). Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related problems. All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST at each of two sites. In addition, the parents and the child will receive individual therapy for 12 weeks. The child will be monitored to evaluate his/her response to therapy. Assessments will take place before and just following treatment, and then 6 and 12 months post-treatment. A child may be eligible for this study if he/she: Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14 years old.

Detailed description

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.

Interventions

BEHAVIORALTrauma-Focused CBT

Structured skills, exposure, trauma-specific interventions

BEHAVIORALChild-Centered Therapy

Client-directed supportive interventions

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Medicine and Dentistry of New Jersey
CollaboratorOTHER
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD12 weeks; 6- and 12- month follow-upChange in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL

Secondary

MeasureTime frameDescription
Anxiety12 weeks; 6 and 12-month follow-upChange in child anxiety symptoms measured by State Trait Anxiety Inventory
Maldaptive Cognitions12 weeks; 6 and 12 month follow-upChange in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
Shame12 weeks; 6 and 12 month follow upChange in child shame measured by SHAME scale
Depression12 weeks; 6- and 12-month follow upChange in child depressive symptoms measured by the Child Depression Inventory
Parent Emotional Distress12 weeks; 6 and 12 month follow upChange in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire
Parental Support12 weeks; 6 and 12 month follow upChange in parental support of child measured by Parental Support Questionnaire
Positive Parenting Practices12 weeks; 6 and 12 month follow upChange in positive parenting measured by Parenting Practices Questionnaire
Parent depression12 weeks; 6 and 12 month follow upChange in parental depression measured by Beck Depression Inventory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026