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

Study Overview
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Brief Summary
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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
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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 Title
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Treatment of PTSD in Sexually Abused Children

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Trauma-Focused CBT
* Behavioral: Child-Centered Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma-Focused CBT<br>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. | Behavioral: Trauma-Focused CBT<br>* Structured skills, exposure, trauma-specific interventions<br>* Other names: TF-CBT;|
| Active Comparator: Child Centered Therapy<br>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. | Behavioral: Child-Centered Therapy<br>* Client-directed supportive interventions<br>* Other names: CCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD | Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL | 12 weeks; 6- and 12- month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Change in child depressive symptoms measured by the Child Depression Inventory | 12 weeks; 6- and 12-month follow up | 
| Anxiety | Change in child anxiety symptoms measured by State Trait Anxiety Inventory | 12 weeks; 6 and 12-month follow-up | 
| Maldaptive Cognitions | Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale | 12 weeks; 6 and 12 month follow-up | 
| Shame | Change in child shame measured by SHAME scale | 12 weeks; 6 and 12 month follow up | 
| Parent depression | Change in parental depression measured by Beck Depression Inventory | 12 weeks; 6 and 12 month follow up | 
| Parent Emotional Distress | Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire | 12 weeks; 6 and 12 month follow up | 
| Parental Support | Change in parental support of child measured by Parental Support Questionnaire | 12 weeks; 6 and 12 month follow up | 
| Positive Parenting Practices | Change in positive parenting measured by Parenting Practices Questionnaire | 12 weeks; 6 and 12 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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