Trial Outcomes & Findings for Tx for Child Sexual Behavior Problems (NCT NCT02625571)

Last Updated: 2019-10-21

Results Overview

Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

4-6 months

Results posted on

2019-10-21

Participant Flow

No details to provide. All recruited participants were enrolled.

Participant milestones

Participant milestones
Measure	Intervention Phase-based treatment of sexual behavior problems of children
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tx for Child Sexual Behavior Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=10 Participants Phase-based treatment of sexual behavior problems of children
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	8 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized White/European descent	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-White/European descent	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Phase-based treatment of sexual behavior problems of children
Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) Pre-Treatment	28.8 Scores on a scale Standard Deviation 17.0
Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI) Post-Treatment	18.1 Scores on a scale Standard Deviation 19.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Phase-based treatment of sexual behavior problems of children
Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) Pre-treatment	80.0 Score on a scale Standard Deviation 17.7
Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC) Post-treatment	69.6 Score on a scale Standard Deviation 26.2

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian Allen

Penn State College of Medicine

Phone: 717-531-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place