Optimal Treatment Strategies for Sexually Abused Children

NCT00073684 | Completed Phase 3 DMC

• 2 other identifiers: R01MH064776DSIR 84-CTS
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child Abuse, Sexual

Keywords

Stress Disorders, Post-Traumatic; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• K-SADS-PL PTSD

  Measured at Months 6 and 12

Secondary Outcomes (1)

• Child Depression Inventory (CDI)

  Measured at Months 6 and 12

Study Arms (4)

1

EXPERIMENTAL

Participants will receive 8 sessions of TF-CBT with narrative.

Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Brief abuse-focused treatment

2

EXPERIMENTAL

Participants will receive 8 sessions of TF-CBT without narrative.

Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Brief coping skills treatment

3

EXPERIMENTAL

Participants will receive 16 sessions of TF-CBT with narrative.

Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Extended abuse-focused treatment

4

EXPERIMENTAL

Participants will receive 16 sessions of TF-CBT without narrative.

Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Extended coping skills treatment

Interventions

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.

1; 2; 3; 4

Brief abuse-focused treatment BEHAVIORAL

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

1

Brief coping skills treatment BEHAVIORAL

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

2

Extended abuse-focused treatment BEHAVIORAL

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

3

Extended coping skills treatment BEHAVIORAL

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

4

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rowan University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

CARES Institute

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

Coitus; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2003
• First Posted: December 3, 2003
• Study Start: August 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

US (1)