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OpenTrials
Completed

NCT Number: NCT02625571

Tx for Child 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.

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Key information

Conditions

Sexual Behavior Behavior

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase-based treatment of sexual behavior problems of children

Behavioral

Primary outcomes

  1. Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)

    Time frame: 4-6 months

    Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.

Secondary outcomes

  1. Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)

    Time frame: 4-6 months

    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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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