Sexual Behavior
Conditions
Brief summary
A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.
Interventions
BEHAVIORALPhase-based treatment of sexual behavior problems of children
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* A caregiver is willing to participate in treatment * A clinically significant T-score on the Child Sexual Behavior Inventory * Child is between the ages of 5 and 12, inclusive
Exclusion criteria
* Child and/or caregiver IQ below 70 * Active child and/or caregiver psychosis or suicidal/homicidal ideation * Active substance use problems of the caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) | 4-6 months | Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) | 4-6 months | The sexual concerns subscale on the TSCYC provides another metric of sexual behaviors of children. Scaore are reported in T-score, which have a mean of 50 and a standard deviation of 10. A score of 65-70 typically indicates a borderline or sub-syndromal level of concern, while a score of 70 or above indicates clinically significant concern. As such, a higher score indicates greater concern. While there is technically no limit for calculating minimum and maximum values, the reported range of scores is typically between 40 and 100. |
Countries
United States
Participant flow
Pre-assignment details
No details to provide. All recruited participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Phase-based treatment of sexual behavior problems of children | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8 years |
| Race/Ethnicity, Customized Non-White/European descent | 6 Participants |
| Race/Ethnicity, Customized White/European descent | 4 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)
Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.
Time frame: 4-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) | Pre-Treatment | 28.8 Scores on a scale | Standard Deviation 17 |
| Intervention | Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) | Post-Treatment | 18.1 Scores on a scale | Standard Deviation 19.2 |
Secondary
Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)
The sexual concerns subscale on the TSCYC provides another metric of sexual behaviors of children. Scaore are reported in T-score, which have a mean of 50 and a standard deviation of 10. A score of 65-70 typically indicates a borderline or sub-syndromal level of concern, while a score of 70 or above indicates clinically significant concern. As such, a higher score indicates greater concern. While there is technically no limit for calculating minimum and maximum values, the reported range of scores is typically between 40 and 100.
Time frame: 4-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) | Pre-treatment | 80.0 Score on a scale | Standard Deviation 17.7 |
| Intervention | Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) | Post-treatment | 69.6 Score on a scale | Standard Deviation 26.2 |