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 — BEHAVIORALPBT 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) — BEHAVIORALThe 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 TreatmentThe 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 TreatmentThe 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
- Brian Allen, PsyD7175314100
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Penn State Hershey Medical Center-TLC Research and Treatment Center | Harrisburg | Pennsylvania | 17110 | Brian Allen 717-531-4100 |