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Completed

NCT Number: NCT00000383

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

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Behavior Coitus Mental Disorders Sexual Behavior Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Children's Support, University of Medicine and Dentistry - New Jersey, Stratford, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study

Treatment and study plan

Trauma-Focused CBT

Behavioral

Structured skills, exposure, trauma-specific interventions

Other names: TF-CBT

Child-Centered Therapy

Behavioral

Client-directed supportive interventions

Other names: CCT

Primary outcomes

  1. PTSD

    Time frame: 12 weeks; 6- and 12- month follow-up

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

Secondary outcomes

  1. Depression

    Time frame: 12 weeks; 6- and 12-month follow up

    Change in child depressive symptoms measured by the Child Depression Inventory

  2. Anxiety

    Time frame: 12 weeks; 6 and 12-month follow-up

    Change in child anxiety symptoms measured by State Trait Anxiety Inventory

  3. Maldaptive Cognitions

    Time frame: 12 weeks; 6 and 12 month follow-up

    Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale

  4. Shame

    Time frame: 12 weeks; 6 and 12 month follow up

    Change in child shame measured by SHAME scale

  5. Parent depression

    Time frame: 12 weeks; 6 and 12 month follow up

    Change in parental depression measured by Beck Depression Inventory

  6. Parent Emotional Distress

    Time frame: 12 weeks; 6 and 12 month follow up

    Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire

  7. Parental Support

    Time frame: 12 weeks; 6 and 12 month follow up

    Change in parental support of child measured by Parental Support Questionnaire

  8. Positive Parenting Practices

    Time frame: 12 weeks; 6 and 12 month follow up

    Change in positive parenting measured by Parenting Practices Questionnaire

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Medicine and Dentistry of New Jersey

Registry information

Official study title

Treatment of PTSD in Sexually Abused Children

Important dates

Study start
1997
Primary completion
2001
Study completion
2002
First posted
Nov 3, 1999
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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