What side effects are associated with this type of intervention?

The most common treatments for Problematic Sexual Behavior (PSB) in preteen children, such as structured cognitive-behavioral therapy (CBT) and other psychosocial interventions, generally have minimal physical side effects. However, some children may experience emotional discomfort, increased anxiety, or resistance to discussing sensitive topics during therapy sessions. These side effects are usually temporary and can be managed with appropriate therapeutic support.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Problematic Sexual Behavior (PSB) in preteen children. The Phase-Based Treatment (PBT) being studied is a structured, sequential therapeutic approach targeting specific phases of behavior modification, but it is still in the trial phase. Generally, treatments for behavioral issues in children may include various forms of psychotherapy, such as Cognitive Behavioral Therapy (CBT), but these are not specifically approved for PSB.

What other types of research exist?

Promising, novel alternatives to Phase-Based Treatment (PBT) for Problematic Sexual Behavior (PSB) in preteen children include Cognitive Behavioral Therapy (CBT) and Internet-delivered Cognitive Behavioral Therapy (ICBT). These therapies have shown efficacy in treating various behavioral issues and could be adapted for PSB. Additionally, emerging technologies such as Virtual Reality Exposure Therapy (VRET) and biofeedback-based interventions are being explored for their potential in behavior modification and could offer innovative approaches for PSB treatment.

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Phase-Based Treatment for Problematic Sexual Behavior

N/A

Recruiting

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, typically 12 weeks.

Awards & highlights

Study Summary

This trial will be the first Randomized Controlled Trial of a new protocol, Phase-Based Treatment, for treating problematic sexual behavior in preteen children.

Who is the study for?

This trial is for children aged 4-12 displaying problematic sexual behavior, with a caregiver willing to participate. Children must have certain scores on the CSBI and KBIT-2 tests and be proficient in English. It's not for those outside this age range, lacking English proficiency, or if the caregiver is suspected of abuse.Check my eligibility

What is being tested?

The study compares Phase-based Treatment (PBT) against usual treatments for preteen problematic sexual behavior. This first randomized controlled trial will test if PBT is more effective than standard approaches used currently.See study design

What are the potential side effects?

Since this trial involves psychological treatment methods rather than medication, traditional side effects are not applicable. However, there may be emotional or behavioral responses as part of the therapy process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, typically 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, typically 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, typically 12 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in scores on the Child Sexual Behavior Inventory (CSBI)

Secondary outcome measures

Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)

Change in scores on the Family Sexuality Index (FSI).

Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental TreatmentExperimental Treatment1 Intervention

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

Group II: Control TreatmentActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Problematic Sexual Behavior (PSB) in preteen children, such as Phase-Based Treatment (PBT), utilize a structured, sequential approach that targets specific phases of behavior modification. These treatments often involve cognitive-behavioral techniques, psychoeducation, and skills training to address and modify problematic behaviors. This phased approach is essential for PSB patients as it provides a clear, step-by-step framework that ensures each phase builds on the previous one, facilitating lasting behavioral change and helping patients develop healthier coping mechanisms.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

499 Previous Clinical Trials

2,801,328 Total Patients Enrolled

Media Library

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children Clinical Trial Eligibility Overview. Trial Name: NCT05514730 — N/A

Problematic Sexual Behavior Research Study Groups: Experimental Treatment, Control Treatment

Problematic Sexual Behavior Clinical Trial 2023: Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children Highlights & Side Effects. Trial Name: NCT05514730 — N/A

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514730 — N/A

~22 spots leftby Jan 2026

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