Penn State Hershey Medical Center-TLC Research and Treatment Center
Harrisburg, Pennsylvania, 17110, United States
Location status: Recruiting
NCT Number: NCT05514730
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.
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Request Info4 year–12 year
All sexes
Interventional
Not applicable
Harrisburg, Pennsylvania, 17110, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through study completion, typically 12 weeks.
The CSBI is a widely-used measure of problematic sexual behavior among preteen children. It is completed by caregivers and asks the frequency with which 38 different items were observed over the past six months. Caregivers report frequency using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (at least once per week).
Time frame: Through study completion, typically 12 weeks.
The TSCYC is a widely-used measure of various forms of emotional and behavioral concerns that are commonly associated with the experience of a traumatic event. One subscale, Sexual Concerns, assesses the child's display of sexual behaviors and anxiety around sexual topics. Scores are reported in T-scores, which have an average of 50 and a standard deviation of 10. Higher scores indicate greater concerns.
Time frame: Through study completion, typically 12 weeks.
The FSI assesses the frequency with which various forms of social modeling of sex occurs in the home. The FSI is a 14-item measure and each item is answered with a No (0) or Yes (1). The items are then summed to compute a raw score with higher scores indicating a greater display of sexuality in the home.
Time frame: Through study completion, typically 12 weeks.
The SDQ is a widely used measure of emotional and behavioral concerns of children. The Conduct Problems subscale specifically assessing behavioral problems, such as oppositionality, lying, and stealing. This subscale includes 5 items that are scored on a scale from 0 (Not True) to 2 (Certainly True). Higher summed scores indicate greater concerns in this area.
Contact information is provided by the study sponsor or research team.
Milton S. Hershey Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.