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Optimal Treatment Strategies for Sexually Abused Children
This study is ongoing, but not recruiting participants.
Study NCT00073684   Information provided by National Institute of Mental Health (NIMH)
First Received: December 2, 2003   Last Updated: August 26, 2008   History of Changes

December 2, 2003
August 26, 2008
August 2003
February 2009   (final data collection date for primary outcome measure)
K-SADS-PL PTSD [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00073684 on ClinicalTrials.gov Archive Site
Child Depression Inventory (CDI) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
Same as current
 
Optimal Treatment Strategies for Sexually Abused Children
Young Sexually Abused Children: Optimal CBT Strategies

This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children.

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.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Child Abuse, Sexual
  • Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT)
  • Behavioral: Brief abuse-focused treatment
  • Behavioral: Brief coping skills treatment
  • Behavioral: Extended abuse-focused treatment
  • Behavioral: Extended coping skills treatment
  • Experimental: Participants will receive 8 sessions of TF-CBT with narrative.
  • Experimental: Participants will receive 8 sessions of TF-CBT without narrative.
  • Experimental: Participants will receive 16 sessions of TF-CBT with narrative.
  • Experimental: Participants will receive 16 sessions of TF-CBT without narrative.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
240
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sexual abuse that has occurred within 24 months of the study. The abuse must have been substantiated by child protective services, charges must have been pressed by the prosecutor's office, or there must have been independent confirmation of abuse by a professional with recognized expertise in conducting investigative evaluations.
  • Kiddie-Sads-Present and Lifetime Version (K-SADS-PL) criteria for partial or full post-traumatic stress disorder (PTSD)
  • Parental consent
  • Caretaker who has not abused the child

Exclusion Criteria:

  • Mental Retardation (IQ less than 70) or placement in special education classes
  • DSM-IV criteria for Pervasive Developmental Disorders
  • Psychotic disorder
  • Serious medical illness that could interfere with the study
  • In temporary, emergency foster care. If a child is returned home or placed in short-term foster care that is anticipated to last a minimum of 4 months, then the child is eligible for participation.
  • Parent who meets DSM-IV criteria for a psychotic disorder
  • Parents with serious mental health problems that result in substantial functional impairment
  • Unsupervised contact with abuse perpetrator
  • Receiving concurrent psychiatric treatment for the abuse. If participants previously received sexual abuse treatment that did not resolve symptomology, they are eligible to participate. In addition, children who have contact with a psychiatrist for medication monitoring purposes may be included if their medication and dosage have remained stable for at least 6 weeks prior to study start
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073684
Esther Deblinger, PhD, UMDNJ-SOM
R01 MH64776, DSIR 84-CTS
National Institute of Mental Health (NIMH)
 
 
National Institute of Mental Health (NIMH)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP