Clinical trial NCT05514730: Treatment for Problematic Sexual Behavior of Preteen Children
Official title: Treatment for Problematic Sexual Behavior of Preteen Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problematic Sexual Behavior Among Preteen Children
Keywords: Problematic sexual behavior
Child treatment/intervention
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two conditions will be employed, PBT and treatment-as-usual, and participants will be randomly assigned to condition using a blocked randomization procedure balancing for gender and age.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in scores on the Child Sexual Behavior Inventory (CSBI)
timeFrame: Through study completion, typically 12 weeks.
Secondary outcomes:
measure: Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
timeFrame: Through study completion, typically 12 weeks.
measure: Change in scores on the Family Sexuality Index (FSI).
timeFrame: Through study completion, typically 12 weeks.
measure: Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Through study completion, typically 12 weeks.
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Penn State Hershey Medical Center-TLC Research and Treatment Center
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.