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Treatment for Problematic Sexual Behavior of Preteen Children

Primary Purpose

Problematic Sexual Behavior Among Preteen Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children
Treatment-as-Usual (TAU)
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problematic Sexual Behavior Among Preteen Children focused on measuring Problematic sexual behavior, Child treatment/intervention

Eligibility Criteria

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

Inclusion Criteria:

  • Child between ages 4 and 12 years
  • Caregiver reports a raw score on the CSBI greater than 4.
  • A primary caregiver is willing to participate in treatment.
  • Child earns a scaled score above 69 on the Kaufman Brief Intelligence Test (KBIT-2)
  • Child proficient in spoken English
  • Caregiver proficient in written and spoken English.

Exclusion Criteria:

  • Child is less than 4 years of age or older than 12 years of age.
  • Caregiver reports a score on the CSBI lower than 4
  • A primary caregiver is unwilling to participate in treatment.
  • Child scored lower than 70 on the KBIT-2.
  • The primary caregiver is suspected of perpetrating child sexual abuse.
  • Child not proficient in spoken English.
  • Caregiver not proficient in both written and spoken English.

Sites / Locations

  • Penn State Hershey Medical Center-TLC Research and Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Control Treatment

Arm Description

The experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing.

The Control Treatment will utilize a Treatment-as-Usual (TAU) condition designed to mimic the types of treatment generally provided in the community for mental health concerns of children.

Outcomes

Primary Outcome Measures

Change in scores on the Child Sexual Behavior Inventory (CSBI)
The CSBI is a widely-used measure of problematic sexual behavior among preteen children. It is completed by caregivers and asks the frequency with which 38 different items were observed over the past six months. Caregivers report frequency using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (at least once per week).

Secondary Outcome Measures

Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
The TSCYC is a widely-used measure of various forms of emotional and behavioral concerns that are commonly associated with the experience of a traumatic event. One subscale, Sexual Concerns, assesses the child's display of sexual behaviors and anxiety around sexual topics. Scores are reported in T-scores, which have an average of 50 and a standard deviation of 10. Higher scores indicate greater concerns.
Change in scores on the Family Sexuality Index (FSI).
The FSI assesses the frequency with which various forms of social modeling of sex occurs in the home. The FSI is a 14-item measure and each item is answered with a No (0) or Yes (1). The items are then summed to compute a raw score with higher scores indicating a greater display of sexuality in the home.
Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a widely used measure of emotional and behavioral concerns of children. The Conduct Problems subscale specifically assessing behavioral problems, such as oppositionality, lying, and stealing. This subscale includes 5 items that are scored on a scale from 0 (Not True) to 2 (Certainly True). Higher summed scores indicate greater concerns in this area.

Full Information

First Posted
August 22, 2022
Last Updated
January 11, 2023
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05514730
Brief Title
Treatment for Problematic Sexual Behavior of Preteen Children
Official Title
Treatment for Problematic Sexual Behavior of Preteen Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Relatively little is known about the treatment of problematic sexual behavior (PSB) displayed by preteen children. Randomized controlled trials (RCTs) examining potential treatments are rare and the available results to date are generally underwhelming. A new protocol, termed Phase-Based Treatment (PBT) for Preteen PSB, has shown positive results in an early stage pilot and during community implementation efforts. This trial will be the first RCT of PBT and aim to determine whether PBT might outperform a treatment-as-usual condition.
Detailed Description
In 2015, a new intervention, PBT, was designed that relied on the current etiological research on PSB and the state-of-the-science regarding behavior change among children. A small pilot of the protocol yielded positive results. Although the pilot included only 10 participants, statistically significant pre-post changes were observed for general PSB, intrusive forms of sexual behavior, and social modeling of sexuality in the home. Training in PBT was provided to a limited number of practicing clinicians in the state of Texas and program evaluation metrics were included. Pre-post change for general PSB was significant, as were changes for intrusive forms of sexual behavior. Despite positive outcomes in non-controlled research, it is unclear whether PBT achieves effects larger than might be seen with more general, non-specific forms of intervention. To demonstrate such an effect requires the completion of a randomized controlled trial (RCT). However, a number of feasibility issues must be answered before conducting a large scale, definitive RCT. As such, the current RCT is conceived as a feasibility project to determine the likelihood of successfully recruiting and retaining a sufficient number of participants, to derive comparative effect size estimates between PBT and SAU to inform later power analyses, and to ascertain participant satisfaction with PBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problematic Sexual Behavior Among Preteen Children
Keywords
Problematic sexual behavior, Child treatment/intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two conditions will be employed, PBT and treatment-as-usual, and participants will be randomly assigned to condition using a blocked randomization procedure balancing for gender and age.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be unaware of whether they are assigned to the experimental or control condition. Research assistants collecting data will similarly be unaware of the participant's condition during assessment.
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
The experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing.
Arm Title
Control Treatment
Arm Type
Active Comparator
Arm Description
The Control Treatment will utilize a Treatment-as-Usual (TAU) condition designed to mimic the types of treatment generally provided in the community for mental health concerns of children.
Intervention Type
Behavioral
Intervention Name(s)
Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children
Intervention Description
PBT is a skills-based protocol that primarily works with caregivers to manage problematic behavior and to teach children healthy information about sex and sexuality. It was designed based on the current empirical knowledge regarding the etiology and treatment of childhood problematic sexual behavior. It is delivered in 12 weekly sessions, with each session lasting approximately 50 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-Usual (TAU)
Intervention Description
The TAU intervention designed for this trial relies largely on the delivery of child-focused treatment techniques, particularly on the development of therapeutic rapport through the utilization of non-directive techniques. These sessions are supplemented with educational materials for the caregiver on child behavior and parenting recommendations. This treatment is designed to be administered over 12 weekly sessions, with each session lasting approximately 50 minutes.
Primary Outcome Measure Information:
Title
Change in scores on the Child Sexual Behavior Inventory (CSBI)
Description
The CSBI is a widely-used measure of problematic sexual behavior among preteen children. It is completed by caregivers and asks the frequency with which 38 different items were observed over the past six months. Caregivers report frequency using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (at least once per week).
Time Frame
Through study completion, typically 12 weeks.
Secondary Outcome Measure Information:
Title
Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
Description
The TSCYC is a widely-used measure of various forms of emotional and behavioral concerns that are commonly associated with the experience of a traumatic event. One subscale, Sexual Concerns, assesses the child's display of sexual behaviors and anxiety around sexual topics. Scores are reported in T-scores, which have an average of 50 and a standard deviation of 10. Higher scores indicate greater concerns.
Time Frame
Through study completion, typically 12 weeks.
Title
Change in scores on the Family Sexuality Index (FSI).
Description
The FSI assesses the frequency with which various forms of social modeling of sex occurs in the home. The FSI is a 14-item measure and each item is answered with a No (0) or Yes (1). The items are then summed to compute a raw score with higher scores indicating a greater display of sexuality in the home.
Time Frame
Through study completion, typically 12 weeks.
Title
Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
Description
The SDQ is a widely used measure of emotional and behavioral concerns of children. The Conduct Problems subscale specifically assessing behavioral problems, such as oppositionality, lying, and stealing. This subscale includes 5 items that are scored on a scale from 0 (Not True) to 2 (Certainly True). Higher summed scores indicate greater concerns in this area.
Time Frame
Through study completion, typically 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child between ages 4 and 12 years Caregiver reports a raw score on the CSBI greater than 4. A primary caregiver is willing to participate in treatment. Child earns a scaled score above 69 on the Kaufman Brief Intelligence Test (KBIT-2) Child proficient in spoken English Caregiver proficient in written and spoken English. Exclusion Criteria: Child is less than 4 years of age or older than 12 years of age. Caregiver reports a score on the CSBI lower than 4 A primary caregiver is unwilling to participate in treatment. Child scored lower than 70 on the KBIT-2. The primary caregiver is suspected of perpetrating child sexual abuse. Child not proficient in spoken English. Caregiver not proficient in both written and spoken English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Allen, PsyD
Phone
7175314100
Email
ballen1@pennstatehealth.psu.edu
Facility Information:
Facility Name
Penn State Hershey Medical Center-TLC Research and Treatment Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Allen
Phone
717-531-4100

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data are available in a de-identified form to other researchers pending presentation of an approved IRB protocol and completion of an appropriate data usage agreement.
IPD Sharing Time Frame
Data will become available approximately 12 months after the completion of data collection.
IPD Sharing Access Criteria
Contact the principal investigator for more information.
Citations:
Citation
Allen, B., Berliner, L., Shenk, C. E., Bendixsen, B., Zellhoefer, A., Dickmann, C. R., Arnold, B., & Chen, M. J. (2018). Development and pilot testing of a phase-based treatment for preteen children with problematic sexual behavior. Evidence-based Practice in Child and Adolescent Mental Health, 3, 274-285.
Results Reference
background
Citation
Dickmann, C. R., Zellhoefer, A., Arnold, B., & Allen, B. (2018). Implementing a phase-based treatment for preteen children with problematic sexual behavior: Case examples. Evidence-based Practice in Child and Adolescent Mental Health, 3, 286-293.
Results Reference
background

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Treatment for Problematic Sexual Behavior of Preteen Children

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