Phase-Based Treatment for Problematic Sexual Behavior

Overseen By Brian Allen, PsyD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Age, CSBI score, Caregiver participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for preteen children who display problematic sexual behavior (PSB). It focuses on testing Phase-Based Treatment (PBT) to determine its effectiveness compared to usual community treatments. The study involves two groups: one receiving PBT and the other receiving standard care. Children aged 4 to 12 with a history of concerning sexual behaviors, whose caregivers can participate, are suitable for this trial. As an unphased trial, participants contribute to pioneering research that could shape future treatment options.

Do I need to stop my child's current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for preteen children?

Research shows that Phase-Based Treatment (PBT) for preteen children with problematic sexual behavior looks promising in early studies. In past community trials, 56.5% of 108 participants completed the treatment. This rate is similar to other community-based treatments, suggesting that most participants can manage PBT.

While specific details about side effects aren't provided, the completion rate indicates that PBT is generally well-tolerated. This trial aims to evaluate how well PBT works compared to usual treatments. Participants can feel reassured that PBT has been tested in community settings with positive early results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Phase-Based Treatment (PBT) for Problematic Sexual Behavior in preteens because it offers a structured and innovative approach compared to traditional therapies like cognitive behavioral therapy (CBT), which are typically used for managing such behaviors. Unlike standard treatments that may provide a one-size-fits-all approach, PBT is tailored to address the specific phases of problematic behavior, potentially leading to more effective and personalized interventions. This method allows for targeting specific behavioral issues at each stage, which could improve outcomes and help children and families more effectively manage these challenges.

What evidence suggests that this trial's treatments could be effective for problematic sexual behavior in preteen children?

Research has shown that Phase-Based Treatment (PBT), which participants in this trial may receive, can help preteen children with problematic sexual behavior. Earlier studies found significant improvements in general problematic sexual behavior, particularly in interpersonal and intrusive behaviors. PBT guides children and their caregivers to understand the causes of these behaviors and teaches them ways to change. Results from community trials demonstrated that PBT is effective and leads to positive outcomes. This suggests that PBT can be a useful approach for addressing problematic sexual behaviors in children. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Child proficient in spoken English

Child earns a scaled score above 69 on the Kaufman Brief Intelligence Test (KBIT-2)

My child is between 4 and 12 years old.

Exclusion Criteria

Child not proficient in spoken English

Caregiver reports a score on the CSBI lower than 4

My child is either under 4 years old or over 12 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Phase-Based Treatment (PBT) or Treatment-as-Usual (TAU) for Problematic Sexual Behavior of Preteen Children

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children
• Treatment-as-Usual (TAU)

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental Treatment Experimental Treatment 1 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 Treatment Active Control 1 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.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

This meta-analysis of 11 studies involving various treatments for sexual behavior problems in children found a significant overall improvement, with a 0.46 standard deviation decline in sexual behavior problems and a 0.49 decline in general behavior problems after treatment.

The study highlighted that caregiver involvement through Parenting/Behavior Management Skills was a strong predictor of positive outcomes, while treatments based on Adult Sex Offender models were less effective, suggesting a need for more child-focused approaches in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of treatment for child sexual behavior problems: practice elements and outcomes. St Amand, A., Bard, DE., Silovsky, JF.[2019]

A study involving 31 adolescents who completed Problematic Sexual Behavior - Cognitive Behavioral Therapy for Adolescents (PSB-CBT-A) showed a significant reduction in problematic sexual behaviors, with scores dropping from an average of 5.33 to 0.17 after treatment.

Participants also experienced significant decreases in internalizing and externalizing problems, indicating that PSB-CBT-A may effectively address broader behavioral issues in adolescents with problematic sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary findings of problematic sexual behavior-cognitive-behavioral therapy for adolescents in an outpatient treatment setting. Jenkins, CS., Grimm, JR., Shier, EK., et al.[2021]

In a study of 1,881 children and adolescents, those with sexual behavior problems (SBP) showed greater psychopathology at a 12-month follow-up compared to those without such problems (NSBP), indicating that SBP may be associated with more severe mental health issues.

Despite the differences in psychopathology, both groups had similar rates of future sexual and nonsexual offenses, suggesting that having sexual behavior problems does not increase the likelihood of future offending compared to those without such problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcome and criminal offending by youth with sexual behavior problems. Letourneau, EJ., Chapman, JE., Schoenwald, SK.[2021]

The study involved 100 community members across eight locations in the U.S. and found that youth with problematic sexual behavior (PSB) are most commonly identified through victim disclosures and direct observations, with caregivers and school personnel being the primary identifiers.

There are significant challenges in the identification process due to unclear reporting pathways and caregivers' fears, highlighting the need for clear, evidence-based policies to improve early intervention and public health responses to youth PSB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early identification of youth with problematic sexual behavior: A qualitative study. Shawler, P., Silvis, VG., Taylor, EK., et al.[2021]

The paper highlights that problematic sexual behavior (PSB) in preteen children is not well understood due to a lack of clinical trial research, making it challenging for clinicians to develop effective treatment strategies.

However, the review suggests that established interventions, informed by etiological research and frameworks like developmental psychopathology and social learning theory, can be effective in treating PSB, and it provides a treatment planning algorithm to guide clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etiological Perspectives on Problematic Sexual Behavior of Preteen Children: Implications for Treatment. Allen, B.[2023]

A new single-item screening tool for identifying problematic sexual behavior (PSB) in preteen children has shown strong test-retest reliability (phi = 0.70-0.74) and validity, making it a promising option for mental health professionals.

Caregivers' positive responses on this tool correlated with significantly higher scores on a comprehensive measure of PSB, indicating its effectiveness in detecting concerns, although it did not differentiate between internalizing issues or posttraumatic stress symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of a single-item screening tool for the presence of problematic sexual behavior among preteen children. Allen, B., Pistone, LF.[2023]

Adolescents aged 13 to 17 are a significant portion of sexual abuse perpetrators, and while they often have trauma histories, treatment typically focuses on reducing reoffending rather than addressing their own trauma.

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is proposed as a potential intervention for adolescents with problematic sexual behaviors (PSB-A) who have experienced trauma, highlighting the need for therapeutic approaches that consider their unique risks and needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a trauma focused cognitive behavioral therapy application for adolescents with problematic sexual behaviors: A conceptual framework. Grady, MD., Yoder, J., Deblinger, E., et al.[2023]

Citations

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tandfonline.com

tandfonline.com/doi/full/10.1080/23794925.2025.2534941

Phase-Based Treatment for Problematic Sexual Behavior ...

Analyses revealed significant improvements in general PSB (t = 10.81, p < .001, d = 1.39) and interpersonal/intrusive forms of PSB (t = 12.8, p ...

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med.psu.edu

med.psu.edu/phase-based-treatment-of-preteen-problematic-sexual-behavior

Phase-Based Treatment of Preteen Problematic Sexual ...

PBT is a treatment for children (3-12) with problematic sexual behavior, working with caregivers to identify factors and teach behavior change techniques.

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awspntest.apa.org/record/2026-43983-001

Phase-based treatment for problematic sexual behavior of ...

Phase-based treatment for problematic sexual behavior of preteen children: Clinical outcomes from community implementation trials. Citation.

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withpower.com

withpower.com/trial/phase-problematic-sexual-behavior-among-preteen-children-11-2022-3931b

Phase-Based Treatment for Problematic Sexual Behavior

This trial tests a new treatment called Phase-Based Treatment (PBT) for preteen children with problematic sexual behavior. PBT aims to help children ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0145213425003503

Descriptive characteristics and exploratory treatment ...

Results support findings that PSB-CBT within CYACs is a developmentally appropriate treatment to reduce sexual behavior problems and parenting stress. Providing ...

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calio.dspacedirect.org

calio.dspacedirect.org/items/4d419480-cae5-4a00-b2e0-e6e969cdae1d

Phase-Based Treatment for Problematic Sexual Behavior of ...

Results: Of 108 cases that began treatment, 61 completed the PBT protocol (56.5%); this retention rate is comparable to other community trials and evaluations.

7.

tandfonline.com

tandfonline.com/doi/pdf/10.1080/23794925.2025.2534941

Phase-Based Treatment for Problematic Sexual Behavior ...

This paper reports on the commu- nity implementation of Phased-Based Treatment (PBT) for preteen problematic sexual behavior. (PSB), an evidence-informed and ...

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researchgate.net

researchgate.net/publication/392130022_Phase-based_Treatment_for_Problematic_Sexual_Behavior_of_Preteen_Children_Clinical_outcomes_from_community_implementation_trials

Phase-Based Treatment for Problematic Sexual Behavior ...

Results: Of 108 cases that began treatment, 61 completed the PBT protocol (56.5%); this retention rate is comparable to other community trials ...