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Tx for Child Sexual Behavior Problems

Primary Purpose

Sexual Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase-based treatment of sexual behavior problems of children
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Behavior

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2015
Last Updated
September 27, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02625571
Brief Title
Tx for Child Sexual Behavior Problems
Official Title
Development and Pilot Testing of a Treatment for Children With Sexual Behavior Problems
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Phase-based treatment of sexual behavior problems of children
Primary Outcome Measure Information:
Title
Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)
Description
Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.
Time Frame
4-6 months
Secondary Outcome Measure Information:
Title
Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)
Description
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.
Time Frame
4-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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