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 tests a new treatment called Phase-Based Treatment (PBT) for preteen children with problematic sexual behavior. PBT aims to help children understand and change their behaviors using the latest research. The trial will compare PBT to usual treatments to see if it works better.

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.

How is Phase-Based Treatment for Problematic Sexual Behavior of Preteen Children different from other treatments?

Phase-Based Treatment for Problematic Sexual Behavior of Preteen Children is unique because it is specifically designed to address the developmental and psychological needs of preteen children with problematic sexual behavior, using a structured approach that incorporates insights from developmental psychopathology, social learning theory, and trauma-related symptoms. Unlike other treatments, it provides a tailored treatment planning algorithm to guide clinicians in selecting the most effective interventions for each child. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children?

Research suggests that early intervention for youth with problematic sexual behavior (PSB) shows strong promise, and established interventions may be effective for treating PSB. A meta-analysis found that treatments focusing on caregiver involvement, like Parenting/Behavior Management Skills, were effective in reducing sexual and general behavior problems in children. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Early identification of youth with problematic sexual behavior: A qualitative study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of treatment for child sexual behavior problems: practice elements and outcomes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment outcome and criminal offending by youth with sexual behavior problems. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Developing a trauma focused cognitive behavioral therapy application for adolescents with problematic sexual behaviors: A conceptual framework. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Preliminary findings of problematic sexual behavior-cognitive-behavioral therapy for adolescents in an outpatient treatment setting. [2021]