NCT02625571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

December 2, 2015

Results QC Date

August 15, 2019

Last Update Submit

September 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    4-6 months

Study Arms (1)

Intervention

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

Interventions

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Brian Allen
Organization
Penn State College of Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

October 21, 2019

Results First Posted

October 21, 2019

Record last verified: 2019-09

Locations