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Optimal Treatment Strategies for Sexually Abused Children - Article


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Child Dental Health

Dental Health, Child


Clinical Trial: Optimal Treatment Strategies for Sexually Abused Children

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine the necessity of including abuse-focused interventions in the treatment of sexually abused children. This study will also determine the optimal length of treatment.

Condition Treatment or Intervention Phase
Child Abuse, Sexual
Stress Disorders, Post-Traumatic
 Behavior: Abuse-focused Cognitive Behavioral Therapy
Phase III

MedlinePlus related topics:  Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Young Sexually Abused Children: Optimal CBT Strategies

Further Study Details: 

Expected Total Enrollment:  120

Study start: August 2003;  Expected completion: July 2008

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.

Eligibility

Ages Eligible for Study:  4 Years   -   11 Years,  Genders Eligible for Study:  Both

Criteria

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 < 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.

Location and Contact Information

Lori Rappenecker, MA      856-566-7036    rappenla@umdnj.edu
Esther Deblinger, PhD      856-566-7036    deblines@umdnj.edu

New Jersey
      Center for Children's Support University of Medicine & Dentistry of NJ - School of Osteopathic Medicine, Stratford,  New Jersey,  08084,  United States; Recruiting
Lori Rappenecker, MA  856-566-7036    rappenla@umdnj.edu 
Esther Deblinger, PhD  856-566-7036    deblines@umdnj.edu 
Esther Deblinger, PhD,  Principal Investigator
Melissa Runyon, PhD,  Sub-Investigator

More Information

CBT-CSA; Cognitive behavioral therapy for child sexual abuse

Study ID Numbers:  MH64776-01A2
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  December 2, 2003
ClinicalTrials.gov Identifier:  NCT00073684
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 17, 2004
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