Recruiting

Sexual Behavior Treatment

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT05514730

Conditions

Problematic Sexual Behavior Among Preteen Children

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children

Treatment-as-Usual (TAU)

Study Details

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.

Conditions

Problematic Sexual Behavior Among Preteen Children

Study ID

NCT05514730

Start date

Jan 9, 2023

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Treatment

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

active comparator: Control Treatment

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.

Interventions

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children

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.

Treatment-as-Usual (TAU)

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

  • Change in scores on the Child Sexual Behavior Inventory (CSBI) [ Time Frame: Through study completion, typically 12 weeks. ]

Central Contacts and Locations

Central contacts

Brian Allen, PsyD

7175314100ballen1@pennstatehealth.psu.edu

Locations

Penn State Hershey Medical Center-TLC Research and Treatment Center

Recruiting

Harrisburg, Pennsylvania, United States, 17110

Contacts

Brian Allen

717-531-4100

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Problematic sexual behavior
  • Child treatment/intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-02-27.