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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 2, 2003 |
| Last Updated Date | August 26, 2008 |
| Start Date ICMJE | August 2003 |
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
K-SADS-PL PTSD [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00073684 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Child Depression Inventory (CDI) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Optimal Treatment Strategies for Sexually Abused Children |
| Official Title ICMJE | Young Sexually Abused Children: Optimal CBT Strategies |
| Brief Summary | This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children. |
| Detailed Description | Child sexual abuse is a serious public health problem that places children at high risk for developing anxiety, mood, conduct, sexual, and substance abuse disorders. It also increases their likelihood of experiencing further victimization. It is imperative that abused children are provided with effective interventions to minimize their risk of developing problems that can be disruptive to their psychosocial development. Evidence suggests that cognitive behavioral therapy (CBT) can effectively ameliorate many abuse-related symptoms exhibited by sexually abused children and their parents. However, it is unknown whether CBT treatment should include gradual exposure (GE), an intervention that involves the gradual confrontation of abuse-related thoughts and memories with therapist feedback to assist the child in effectively processing the abusive experience. Because this component of CBT may be more difficult for children and their parents, it is important to determine if and when GE is essential for optimal recovery in abused children. Children and their parents will be randomly assigned to receive one of four treatments: brief abuse-focused treatment, brief coping skills treatment, extended abuse-focused treatment, and extended coping skills treatment. Assessments will be conducted before, during, and after treatment and at 6- and 12-month follow-up visits. Standardized evaluations will be conducted to assess parents' distress and support levels; parent reports of children's behavior patterns, sexualized behaviors, and post-traumatic stress disorder (PTSD) symptoms; and children's self-reports of PTSD, depression and anxiety symptoms, body safety skills, and victimization experiences. |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Child Abuse, Sexual |
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 240 |
| Estimated Completion Date | February 2009 |
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 4 Years to 11 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00073684 |
| Responsible Party | Esther Deblinger, PhD, UMDNJ-SOM |
| Study ID Numbers ICMJE | R01 MH64776, DSIR 84-CTS |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | August 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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