Treatment for Problematic Sexual Behavior of Preteen Children

NCT ID: NCT05514730

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2026-01-31

Brief Summary

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.

Detailed Description

In 2015, a new intervention, PBT, was designed that relied on the current etiological research on PSB and the state-of-the-science regarding behavior change among children. A small pilot of the protocol yielded positive results. Although the pilot included only 10 participants, statistically significant pre-post changes were observed for general PSB, intrusive forms of sexual behavior, and social modeling of sexuality in the home. Training in PBT was provided to a limited number of practicing clinicians in the state of Texas and program evaluation metrics were included. Pre-post change for general PSB was significant, as were changes for intrusive forms of sexual behavior.

Despite positive outcomes in non-controlled research, it is unclear whether PBT achieves effects larger than might be seen with more general, non-specific forms of intervention. To demonstrate such an effect requires the completion of a randomized controlled trial (RCT). However, a number of feasibility issues must be answered before conducting a large scale, definitive RCT. As such, the current RCT is conceived as a feasibility project to determine the likelihood of successfully recruiting and retaining a sufficient number of participants, to derive comparative effect size estimates between PBT and SAU to inform later power analyses, and to ascertain participant satisfaction with PBT.

Conditions

Problematic Sexual Behavior Among Preteen Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Treatment

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

Group Type: EXPERIMENTAL

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children

Intervention Type: BEHAVIORAL

PBT 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.

Control Treatment

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.

Group Type: ACTIVE_COMPARATOR

Treatment-as-Usual (TAU)

Intervention Type: BEHAVIORAL

The 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.

Interventions

Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children

PBT 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.

Intervention Type: BEHAVIORAL

Treatment-as-Usual (TAU)

The 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brian Allen, Psy.D.

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State Hershey Medical Center-TLC Research and Treatment Center

Harrisburg, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian Allen, PsyD

Role: CONTACT

ballen1@pennstatehealth.psu.edu

7175314100

Facility Contacts

Brian Allen

Role: primary

717-531-4100

References

Allen, B., Berliner, L., Shenk, C. E., Bendixsen, B., Zellhoefer, A., Dickmann, C. R., Arnold, B., & Chen, M. J. (2018). Development and pilot testing of a phase-based treatment for preteen children with problematic sexual behavior. Evidence-based Practice in Child and Adolescent Mental Health, 3, 274-285.

Reference Type: BACKGROUND

Dickmann, C. R., Zellhoefer, A., Arnold, B., & Allen, B. (2018). Implementing a phase-based treatment for preteen children with problematic sexual behavior: Case examples. Evidence-based Practice in Child and Adolescent Mental Health, 3, 286-293.

Reference Type: BACKGROUND

Other Identifiers

STUDY00020807

Identifier Type: -

Identifier Source: org_study_id