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New therapy aims to help preteens with problematic sexual behavior

NCT ID NCT05514730

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new skills-based therapy called Phase-Based Treatment (PBT) for preteens aged 4-12 who show problematic sexual behavior. The therapy works mainly with caregivers over 12 weekly sessions to teach healthy information about sex and manage behaviors. Researchers will compare PBT to usual care in 42 children to see if it leads to better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Phase-Based Treatment (PBT) - a skills-based behavioral therapy for caregivers and children
What this could lead to
If it works, this could provide an effective, structured therapy option for preteens with problematic sexual behavior, helping families manage and reduce these behaviors.
What could go wrong
This is a small early-stage trial with only 42 participants, so results may not apply broadly. The therapy may not outperform usual care, and success depends on caregiver engagement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Harrisburg, Pennsylvania, 17110, United States