Treatment for Problematic Sexual Behavior of Preteen Children

Penn State Health

Status: Enrolling

Conditions: Problematic Sexual Behavior Among Preteen Children

Treatments: Behavioral: Treatment-as-Usual (TAU); Behavioral: Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children

Study type: Interventional

Funder types: Other

Identifiers

NCT05514730

STUDY00020807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

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

Treatment:

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

Control Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment-as-Usual (TAU)