Treatment for Problematic Sexual Behavior of Preteen Children

Part of paid clinical trials in Harrisburg, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05514730
Status
Recruiting

Conditions

  • Problematic Sexual Behavior Among Preteen Children

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children — BEHAVIORAL
    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) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2023
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Hershey Medical Center-TLC Research and Treatment CenterHarrisburgPennsylvania17110
Brian Allen
717-531-4100

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