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Completed

NCT Number: NCT00073684

Optimal Treatment Strategies for Sexually Abused Children

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

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Key information

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CARES Institute

Stratford, New Jersey, 08084, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma focused cognitive behavioral therapy (TF-CBT)

Behavioral

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.

Brief abuse-focused treatment

Behavioral

Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.

Brief coping skills treatment

Behavioral

Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.

Extended abuse-focused treatment

Behavioral

Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.

Extended coping skills treatment

Behavioral

Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.

Primary outcomes

  1. K-SADS-PL PTSD

    Time frame: Measured at Months 6 and 12

Secondary outcomes

  1. Child Depression Inventory (CDI)

    Time frame: Measured at Months 6 and 12

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Young Sexually Abused Children: Optimal CBT Strategies

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2003
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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