Tx for Child Sexual Behavior Problems

Development and Pilot Testing of a Treatment for Children With Sexual Behavior Problems

A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.

Study Overview

• Status: Completed
• Conditions: Sexual Behavior
• Intervention / Treatment: Behavioral: Phase-based treatment of sexual behavior problems of children

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A caregiver is willing to participate in treatment
• A clinically significant T-score on the Child Sexual Behavior Inventory
• Child is between the ages of 5 and 12, inclusive

Exclusion Criteria:

• Child and/or caregiver IQ below 70
• Active child and/or caregiver psychosis or suicidal/homicidal ideation
• Active substance use problems of the caregiver

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Phase-based treatment of sexual behavior problems of children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)	Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)	The sexual concerns subscale on the TSCYC provides another metric of sexual behaviors of children. Scaore are reported in T-score, which have a mean of 50 and a standard deviation of 10. A score of 65-70 typically indicates a borderline or sub-syndromal level of concern, while a score of 70 or above indicates clinically significant concern. As such, a higher score indicates greater concern. While there is technically no limit for calculating minimum and maximum values, the reported range of scores is typically between 40 and 100.	4-6 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: STUDY00002942

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No