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.

Study Overview

• Status: Completed
• Conditions: Child Abuse, Sexual
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • CARES Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
K-SADS-PL PTSD	Measured at Months 6 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Child Depression Inventory (CDI)	Measured at Months 6 and 12

Collaborators and Investigators

• Sponsor: Rowan University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: December 2, 2003
• First Submitted That Met QC Criteria: December 2, 2003
• First Posted (Estimate): December 3, 2003

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: R01MH064776 (U.S. NIH Grant/Contract); DSIR 84-CTS (Division of Services and Intervention Research)