Tx for Child Sexual Behavior Problems

Sexual Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625571
• Other study ID #: STUDY00002942
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Problem Behavior
• Sexual Behavior

Intervention

Behavioral:
• Phase-based treatment of sexual behavior problems of children

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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