Optimal Treatment Strategies for Sexually Abused Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT00073684
First received: December 2, 2003
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Young Sexually Abused Children: Optimal CBT Strategies

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • K-SADS-PL PTSD [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child Depression Inventory (CDI) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: August 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive 8 sessions of TF-CBT with narrative.
Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT)
This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
Behavioral: Brief abuse-focused treatment
Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.
Experimental: 2
Participants will receive 8 sessions of TF-CBT without narrative.
Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT)
This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
Behavioral: Brief coping skills treatment
Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.
Experimental: 3
Participants will receive 16 sessions of TF-CBT with narrative.
Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT)
This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
Behavioral: Extended abuse-focused treatment
Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.
Experimental: 4
Participants will receive 16 sessions of TF-CBT without narrative.
Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT)
This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
Behavioral: Extended coping skills treatment
Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.

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.

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073684

Locations
United States, New Jersey
CARES Institute
Stratford, New Jersey, United States, 08084
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT00073684     History of Changes
Other Study ID Numbers: R01 MH64776, R01MH064776, DSIR 84-CTS
Study First Received: December 2, 2003
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Stress Disorders, Post-Traumatic
Depression
Anxiety

ClinicalTrials.gov processed this record on April 17, 2014