Clinical trial NCT00073684: Optimal Treatment Strategies for Sexually Abused Children
Official title: Young Sexually Abused Children: Optimal CBT Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child Abuse, Sexual
Keywords: Stress Disorders, Post-Traumatic
Depression
Anxiety
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-03
Enrollment: 210
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: K-SADS-PL PTSD
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
measure: Child Depression Inventory (CDI)
timeFrame: Measured at Months 6 and 12
Other outcomes:
Locations:
city: Stratford
country: United States
facility: CARES Institute
state: New Jersey
Study officials:
References: