Problematic Sexual Behavior Among Preteen ChildrenNCT05514730
Treatment for Problematic Sexual Behavior of Preteen Children
A study testing Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children and Treatment-as-Usual (TAU) in people with Problematic Sexual Behavior Among Preteen Children, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Problematic Sexual Behavior Among Preteen Children
- What is being tested?
- Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children and Treatment-as-Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Hershey Medical Center-TLC Research and Treatment Center
Harrisburg, Pennsylvania, 17110
Brian Allen, 717-531-4100
About this study
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.
Read the 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.
- Being tested
- Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, Treatment-as-Usual (TAU)
- Keywords
- Problematic sexual behavior, Child treatment/intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen ChildrenBehavioural
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.
Treatment-as-Usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | The experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing. Receives: Behavioral: Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children |
| Control Treatment | Active comparator | 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. Receives: Behavioral: Treatment-as-Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on the Child Sexual Behavior Inventory (CSBI)
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).
Measured: Through study completion, typically 12 weeks.
Secondary outcomes (3)
Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
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.
Measured: Through study completion, typically 12 weeks.
Change in scores on the Family Sexuality Index (FSI).
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.
Measured: Through study completion, typically 12 weeks.
Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: Through study completion, typically 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start9 Jan 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Problematic Sexual Behavior Among Preteen ChildrenStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Allen, Psy.D., Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514730
- Sponsor's protocol ID
- STUDY00020807
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data are available in a de-identified form to other researchers pending presentation of an approved IRB protocol and completion of an appropriate data usage agreement.
Publications
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Problematic Sexual Behavior of Preteen Children
- ClinicalTrials.gov ID
- NCT05514730
- Acronym / sponsor ID
- STUDY00020807
- Keywords
- Problematic sexual behavior, Child treatment/intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Behavioral: Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen ChildrenThe experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing. |
| Control Treatment | Active comparator | Behavioral: Treatment-as-Usual (TAU)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 may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen ChildrenPBT 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. | Behavioural | Experimental Treatment |
| 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. | Behavioural | Control Treatment |
Primary outcome
Change in scores on the Child Sexual Behavior Inventory (CSBI)
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).
3 secondary outcomes
Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
Time frame: Through study completion, typically 12 weeks.
Change in scores on the Family Sexuality Index (FSI).
Time frame: Through study completion, typically 12 weeks.
Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Through study completion, typically 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- BackgroundAllen, 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.
- BackgroundDickmann, 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.
- Individual participant dataSharing planned: Yes. All collected data are available in a de-identified form to other researchers pending presentation of an approved IRB protocol and completion of an appropriate data usage agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase-based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children and Treatment-as-Usual (TAU) in people with Problematic Sexual Behavior Among Preteen Children, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Allen, PsyD (7175314100, ballen1@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Child Sexual Behavior Inventory (CSBI) (time frame: Through study completion, typically 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05514730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.