An interventional study of Trauma-Focused CBT and Child-Centered Therapy in Stress Disorders, Post-Traumatic, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Completed at 3 sites in United States. Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2015-03-30.
Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Treatment
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.
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.
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's enrollment of 229 is above the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 47 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Patients must have:
Exclusion Criteria:
4) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
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
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
Structured skills, exposure, trauma-specific interventions
Also known as: TF-CBT
Client-directed supportive interventions
Also known as: CCT
PTSD
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
Depression
Change in child depressive symptoms measured by the Child Depression Inventory
Time frame: 12 weeks; 6- and 12-month follow up
Anxiety
Change in child anxiety symptoms measured by State Trait Anxiety Inventory
Time frame: 12 weeks; 6 and 12-month follow-up
Maldaptive Cognitions
Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
Time frame: 12 weeks; 6 and 12 month follow-up
Shame
Change in child shame measured by SHAME scale
Time frame: 12 weeks; 6 and 12 month follow up
Parent depression
Change in parental depression measured by Beck Depression Inventory
Time frame: 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
Time frame: 12 weeks; 6 and 12 month follow up
Parental Support
Change in parental support of child measured by Parental Support Questionnaire
Time frame: 12 weeks; 6 and 12 month follow up
Positive Parenting Practices
Change in positive parenting measured by Parenting Practices Questionnaire
Time frame: 12 weeks; 6 and 12 month follow up
The record gives a start of Sep 1997, a primary completion of Sep 2001 and a completion of Sep 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)