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Phase-Based Treatment for Problematic Sexual Behavior
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child between ages 4 and 12 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, typically 12 weeks.
Awards & highlights
Study Summary
This trial will be the first Randomized Controlled Trial of a new protocol, Phase-Based Treatment, for treating problematic sexual behavior in preteen children.
Who is the study for?
This trial is for children aged 4-12 displaying problematic sexual behavior, with a caregiver willing to participate. Children must have certain scores on the CSBI and KBIT-2 tests and be proficient in English. It's not for those outside this age range, lacking English proficiency, or if the caregiver is suspected of abuse.Check my eligibility
What is being tested?
The study compares Phase-based Treatment (PBT) against usual treatments for preteen problematic sexual behavior. This first randomized controlled trial will test if PBT is more effective than standard approaches used currently.See study design
What are the potential side effects?
Since this trial involves psychological treatment methods rather than medication, traditional side effects are not applicable. However, there may be emotional or behavioral responses as part of the therapy process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 4 and 12 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, typically 12 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, typically 12 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in scores on the Child Sexual Behavior Inventory (CSBI)
Secondary outcome measures
Change in scores on the Conduct Problems subscale of the Strengths and Difficulties Questionnaire (SDQ)
Change in scores on the Family Sexuality Index (FSI).
Change in scores on the Sexual Concerns subscale of the Trauma Symptom Checklist for Young Children (TSCYC)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental TreatmentExperimental Treatment1 Intervention
The experimental treatment is Phase-Based Treatment (PBT) for Problematic Sexual Behavior of Preteen Children, an innovative intervention demonstrating promise in preliminary testing.
Group II: Control TreatmentActive Control1 Intervention
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.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,780 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is either under 4 years old or over 12 years old.My caregiver is not fluent in English.My child is between 4 and 12 years old.My caregiver can read, write, and speak English well.My primary caregiver is not willing to be involved in the treatment process.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment
- Group 2: Control Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must one meet to be eligible for this clinical experiment?
"To be accepted for this trial, applicants must present with problematic sexual behaviour and should fall between the ages of 4 and 12. Approximately 42 children are being enrolled in total."
Answered by AI
Is there still capacity for participants in the experiment?
"Per the information found on clinicaltrials.gov, patient recruitment is not currently active for this particular trial that was initially posted on December 1st 2022 and revised as recently as August 24th 2022. However, there exist one other investigation concurrently recruiting participants."
Answered by AI
Is the minimum age requirement for this trial 18 years or older?
"This medical study is currently recruiting young individuals aged 4-12 years old."
Answered by AI
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