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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Focused CBT
Child-Centered Therapy
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring 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

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse Confirmed child sexual abuse history Speak English Parent willing to participate in treatment Exclusion Criteria: Active psychotic disorder resulting in inability to participate in CBT 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

Sites / Locations

  • Center for Children's Support, University of Medicine and Dentistry - New Jersey
  • Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
  • Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma-Focused CBT

Child Centered Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PTSD
Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL

Secondary Outcome Measures

Depression
Change in child depressive symptoms measured by the Child Depression Inventory
Anxiety
Change in child anxiety symptoms measured by State Trait Anxiety Inventory
Maldaptive Cognitions
Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
Shame
Change in child shame measured by SHAME scale
Parent depression
Change in parental depression measured by Beck Depression Inventory
Parent Emotional Distress
Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire
Parental Support
Change in parental support of child measured by Parental Support Questionnaire
Positive Parenting Practices
Change in positive parenting measured by Parenting Practices Questionnaire

Full Information

First Posted
November 2, 1999
Last Updated
March 27, 2015
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00000383
Brief Title
Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children
Official Title
Treatment of PTSD in Sexually Abused Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
September 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trauma-Focused CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Child Centered Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Focused CBT
Other Intervention Name(s)
TF-CBT
Intervention Description
Structured skills, exposure, trauma-specific interventions
Intervention Type
Behavioral
Intervention Name(s)
Child-Centered Therapy
Other Intervention Name(s)
CCT
Intervention Description
Client-directed supportive interventions
Primary Outcome Measure Information:
Title
PTSD
Description
Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL
Time Frame
12 weeks; 6- and 12- month follow-up
Secondary Outcome Measure Information:
Title
Depression
Description
Change in child depressive symptoms measured by the Child Depression Inventory
Time Frame
12 weeks; 6- and 12-month follow up
Title
Anxiety
Description
Change in child anxiety symptoms measured by State Trait Anxiety Inventory
Time Frame
12 weeks; 6 and 12-month follow-up
Title
Maldaptive Cognitions
Description
Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
Time Frame
12 weeks; 6 and 12 month follow-up
Title
Shame
Description
Change in child shame measured by SHAME scale
Time Frame
12 weeks; 6 and 12 month follow up
Title
Parent depression
Description
Change in parental depression measured by Beck Depression Inventory
Time Frame
12 weeks; 6 and 12 month follow up
Title
Parent Emotional Distress
Description
Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire
Time Frame
12 weeks; 6 and 12 month follow up
Title
Parental Support
Description
Change in parental support of child measured by Parental Support Questionnaire
Time Frame
12 weeks; 6 and 12 month follow up
Title
Positive Parenting Practices
Description
Change in positive parenting measured by Parenting Practices Questionnaire
Time Frame
12 weeks; 6 and 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse Confirmed child sexual abuse history Speak English Parent willing to participate in treatment Exclusion Criteria: Active psychotic disorder resulting in inability to participate in CBT 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith A. Cohen, MD
Organizational Affiliation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esther Deblinger, PhD
Organizational Affiliation
University of Medicine and Dentistry of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Children's Support, University of Medicine and Dentistry - New Jersey
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15187799
Citation
Cohen JA, Deblinger E, Mannarino AP, Steer RA. A multisite, randomized controlled trial for children with sexual abuse-related PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):393-402. doi: 10.1097/00004583-200404000-00005.
Results Reference
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Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children

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