Development and Pilot Testing of a Treatment for Children With Sexual Behavior Problems
Phase: NA
Conditions: Sexual Behavior
Sponsor: Milton S. Hershey Medical Center

Cover Page 
 
Official Title: Tx for Child Sexual Behavior Problems 
Identifiers: NCT02625571 
Document Date: August 25, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Phase-Based Treatment of PSB Open Trial Protocol 
1.0 Inclusion and Exclusion Criteria 
 
1.1 
Inclusion Criteria 
 
Minor Patients 
 
 Age 5-12 years (inclusive) with a participating consenting caregiver with legal 
standing to consent to treatment for the minor child.  All children 7-12 years 
(inclusive) will be asked to provide assent. Thus, the parent-child dyad will be 
participating, not just the patient child. However, given that children with SBP 
often have co-occurring behavioral problems, such as oppositional or defiant 
behavior, child assent will not be required for the participation of children 
between the ages of 7 and 12 (see section 5.3.3.2 below). 
 Sex:  male or female 
 A T-score > 64 on the Child Sexual Behavior Inventory (CSBI). Note that this 
is a standard practice measure in the child maltreatment field and is currently 
administered to all children between the ages of 3 and 12 who present for 
treatment at the TLC Clinic. 
 Fluent in written and spoken English, as the assessment instruments are not 
available in translations and have not been validated for use with non-English 
speaking populations.  
 
Adult Caregiver 
 
 Parent or Legal Guardian of patient.  Must consent to his/her own 
participation as well as the participation of the child. 
 Self-identified as the primary caregiver (responsible for the day-to-day care of 
the child and who must have lived with the child for at least the last 6 
months). Six months is the minimal amount of time necessary for the 
caregiver to validly complete the assessment measures.  
 Age ≥18 years 
 Sex:  male or female 
 Fluent in written and spoken English. See rationale above regarding measures.  
 
In many instances of a child with SBP, a caregiver is suspected of sexually 
abusing the child. However, these caregivers may retain legal rights as the case 
progresses through the courts and usually these caregivers decline consent for the 
child’s treatment. The TLC Clinic works closely with the PSHMC general 
counsel and has been directed by the general counsel to treat cases under the 
condition that consent is obtained from at least one caregiver/guardian with legal 
standing to consent to the child’s treatment. This direction will also be used in the 
current study. Any objections by a non-custodial parent will be handled through 

normal channels already in place at the TLC Clinic in collaboration with the 
PSHMC general counsel.  
 
1.2 
Exclusion Criteria 
 
Minor Patients 
 Age <5 or >12 years at the time of enrollment as these children fall outside of 
the cognitive capability and/or scientific justifications for use of the 
intervention under investigation.  
 IQ < 70 as measured by the Kaufman Brief Intelligence Test (KBIT; Note: 
This measure is a commonly used instrument in the mental health field and is 
administered at the TLC Clinic as a point of standard care whenever concerns 
are raised about the cognitive ability of a caregiver or child)    
 Developmental delays or severe psychiatric problems that necessitate a higher 
level of care than provided by outpatient treatment 
 
Adult Caregiver 
 Age < 18 years at the time of enrollment 
 IQ < 70 as measured by the Kaufman Brief Intelligence Test. See above about 
the standard care use of this measure.  
 Developmental delays or severe psychiatric problems that necessitate a higher 
level of care than provided by outpatient treatment 
 Caregiver inability to complete assessment measures due to cognitive, 
psychiatric, or other limitation. 
 The available caregiver is suspected or known to have perpetrated sexual 
abuse as indicated by police, Children and Youth Services, or another agency 
with authority on such matters. 
 
1.3 
Early Withdrawal of Subjects 
 
1.3.1 Criteria for removal from study 
 
Participants will be withdrawn from the study if safety reasons dictate a higher 
level of care, such as suicidal ideation or severe aggression. Clinicians utilized in 
this study are trained mental health clinicians capable of identifying and 
determining such a need. In addition, noncompliance with regular session 
attendance may result in withdrawal from the study. Participants are free to 
voluntarily withdraw from the study at any time without penalty. 
 
1.3.2 Follow-up for withdrawn subjects 
 
Participants withdrawn from the study either by the investigator or voluntarily will 
receive appropriate referral information to other providers. In the event of an 
emergency, appropriate emergency referral procedures in place at the TLC Clinic will be 

followed. In the event of withdrawal, no further data will be collected from the 
participants.  
 
2.0 Recruitment Methods 
 
2.1 
Identification of subjects 
Participants will be identified through the standard referral sources currently utilized by 
the general clinical service at the TLC Clinic. This includes referral from the Children’s 
Resource Center, local child protective services agencies, and pediatricians. Children 
meeting criteria and seeking services at the TLC Clinic will be offered the option of 
participating in the study. In addition to referrals, participants will also be recruited 
through flyers posted in within the Hershey Medical Center pediatric clinic, as well as the 
HMC Harrisburg 3rd street location.   
 
2.2 
Recruitment process 
Patients attending the initial TLC Clinic intake assessment process complete the CSBI as 
standard practice at the clinic. Other information regarding the inclusion and exclusion 
criteria for both the child and caregiver are typically available at this intake assessment as 
well. The exception to this is the KBIT, however, clinicians are typically able throughout 
the assessment to determine if significant cognitive limitations are present. Participants 
who appear to meet criteria will be notified of the study and asked if they wish to 
participate.  Those expressing interest will be provided additional information and will be 
notified that a member of the research team will contact them to schedule the initial 
assessment session. In addition to patients of the TLC Clinic, participants will also be 
recruited through flyers within the Hershey Medical Center pediatric clinic and the HMC 
Harrisburg 3rd street location, and will be instructed to call the research line to provide 
their contact information. A research assistant will then call the caregiver to breifly 
screen for inclusion and exclusion critera. Participants meeting eligibility criteria would 
then be scheduled for the first assessment session. At this session, the research assistant 
will review study procedures and document consent/assent, as well as administer the 
additional assessment materials not administered in the initial intake assessment (see 
below: KBIT, FSI, SC). Potential participants who decline participation will still be 
offered standard care through the TLC Clinic using standard rates and billing procedures.     
 
2.3 
Recruitment materials 
Please see attached recruitment flyer text. Recruitment flyer will be created by HMC 
Office of Marketing and Communications. 
 
2.4 
Eligibility/screening of subjects 
Participants will complete a brief phone eligibility screening. Please see attached phone 
screen text. 
 

3.0 Consent Process and Documentation  
 
3.1 
Consent Process  
.  
Patient/caregiver dyads presenting to the TLC Clinic who are 
identified as likely meeting inclusion/exclusion criteria during the 
initial intake assessment will be given the opportunity to participate in 
the research study. Those expressing interest will be contacted by a 
research assistant and the first study assessment session will be 
scheduled at the TLC Clinic. At this first assessment session, the 
informed consent form will be reviewed with patients/caregivers and 
the opportunity to ask questions will be provided. Informed 
consent/assent will then be documented.  
 
 
3.2 
Consent Documentation 
 
The consent process will be documented in writing with the long form of 
consent documentation.  A member of the research team will assist in the 
explanation and obtaining of the written consent.  A copy of the signed 
consent will be given to the participant and another copy will be submitted 
for uploading to the electronic medical record. 
 
 
3.3 
Consent – Other Considerations  
 
3.3.1 Non-English Speaking Subjects 
N/A:  Excluded since the assessment materials used in the current study are only 
available in English, and have not been validated in other languages. 
 
 
3.3.2 Cognitively Impaired Adults 
 
3.3.2.1 Capability of Providing Consent 
All caregivers will complete the Kaufman Brief Intelligence Test during the 
first study assessment. Caregivers receiving scores below 70 (intellectual 
disability) will be excluded from the study. Similarly, the informed consent 
for themselves and their child will be considered invalid and the 
caregiver/child will be removed from the study.  
 

3.3.2.2 
Adults Unable To Consent 
Adults unable to provide consent will not be enrolled in this study. This is 
primarily related to the fact that their participation in reporting on the 
behavior of their child and their ability to implement treatment 
recommendations will be limited. In addition, there would be concerns 
regarding their ability to provide informed consent.  
 
3.3.3 Subjects who are not yet adults (infants, children, teenagers)  
 
3.3.3.1 
Parental Permission 
All children in the study will be between the ages of 5 and 12. Each 
child will require the consent of a legal caregiver. This will be 
obtained at the first study assessment session, which is the first 
contact with the study. In the event that a child resides with a foster or 
kinship caregiver, appropriate legal documents attesting to the ability 
of the caregiver to provide consent will be required. In some instances 
this may necessitate consent from an appropriate authority figure, 
such as Child and Youth Services caseworker or a judge. Regardless, 
instances where the legal caregiver is not a biological parent will be 
recorded along with appropriate documentation.    
 
3.3.3.2 Assent 
We will attempt to obtain assent from all child participants, regardless of 
age. However, we will not view assent as a requirement. Many times 
children with SBP have co-occurring behavioral problems including 
defiance and conduct problems. This may result in some children refusing 
to cooperate; however, removing these children from the study would 
significantly bias results and these children/caregivers remain in need of 
services despite the child’s refusal. In addition, providing mental health 
treatment does not typically require assent from a child under the age of 
14. The research assistant will explain all research procedures to children in 
developmentally appropriate language and solicit questions. When the 
child assents, the child’s signature will be obtained on the consent/assent 
form. 
 
4.0 Study Design and Procedures 
 
4.1 
Study Design  
Participants will receive a 12-session protocol designed to ameliorate SBP among 
preteen children. After completing the first study assessment session, the 
child/caregiver dyad will be assigned to one of the two mental health clinicians 
participating in this trial. The clinician will then implement the protocol in weekly 
sessions. Assessments will be completed after every 4th treatment session, in addition to 

pre-treatment and post-treatment assessments. The assessments will occur with a 
research assistant trained to administer the protocol. The current plan is to also collect 
follow-up data at approximately 4 weeks post-treatment.  
 
4.2 
Study Procedures 
The treatment protocol will utilize cognitive-behavioral change techniques 
commonly used in standard practice and be modeled on currently available group 
treatment protocols for SBP that utilize similar techniques. These techniques are 
already standard practice at the TLC Clinic and administered in an individual 
format; however, this manner of delivery has not been systematically evaluated. 
The innovation of the current project is the definition of an individually-
administered protocol, and thus the model of delivery is experimental, not the 
techniques. Again, even this model of delivery of techniques is standard practice 
in many community settings, including the TLC Clinic, even though it has not 
been systematically evaluated. The only distinction between standard clinical 
practice and the research being conducted is that the data will be more closely 
monitored in this project and outcome assessment will occur after every 4th 
session instead of the standard practice of pre and post-treatment. Participants 
electing not to participate will likely receive the same protocol or potentially an 
alternative treatment through the standard practice of the TLC Clinic. 
Specification of the exact order of techniques is provided below.  
 
The measures for the protocol will be administered during defined assessment 
sessions by a trained research assistant after each 4th session of treatment. The 
next treatment session will not occur until the required assessment session takes 
place. All measures are described below, but each measure is either (1) a 
psychometric instrument assessing emotional/behavioral concerns that is standard 
practice at the TLC Clinic, or (2) designed to elicit information about the 
participant’s treatment experience. It should be emphasized that each of the 
assessments described below are standard instruments employed at the TLC 
Clinic for cases of SBP, including the Child Sexual Behavior Inventory (CSBI). 
The exception is the Kaufman Brief Intelligence Test, which is typically only 
administered if there are significant concerns about cognitive ability. It is 
administered in this study to ensure that participants demonstrate sufficient 
cognitive ability to participate in and benefit from the treatment. All measures are 
provided in the “Supporting Documents” section. The timing of the 
administration of each measure is provided below.  
 
Because each treatment session is conducted by a trained mental health clinician, 
concerns of safety will be identifiable each session if reported by either the 
caregiver or child. Mandated reporting requirements are reviewed with all TLC 
Clinic patients and caregivers at the initial intake assessment and, therefore, these 
limits of confidentiality are described to each potential participant in the current 

study. In accordance with state law, concerns related to child maltreatment, 
homicidal or suicidal ideation will be reported to appropriate authorities.  
 
4.2.1 Sequence of sessions 
1. Initial Intake Assessment at the TLC Clinic: Potential participants are 
identified and recruited through standard TLC Clinic intake and assessment 
procedures. Those interested in participating will receive a phone call from a 
research assistant to schedule the first study assessment session. However, as 
a course of standard practice at the TLC Clinic, all patients (child and 
caregivers) complete the following measures during this initial intake 
assessment and, following informed consent/assent during the first study 
assessment session, these measures will become part of the study record so as 
to prevent needing to re-administer them during the first study assessment 
session: 
A. Child Sexual Behavior Inventory (CSBI): The CSBI is the gold 
standard instrument for the assessment of sexual behaviors and SBP in 
children between the ages of 3 and 12 (ages inclusive; Chaffin, et al., 
2008). The CSBI is a caregiver-report instrument that asks the 
caregiver to report on the frequency of 46 different types of child 
sexual behavior over the past 6 months. The CSBI is used in the 
majority of studies examining SBP in children (e.g., Allen, Thorn, & 
Gully, 2015; Friedrich, Davies, Feher, & Wright, 2003; Silovsky & 
Niec, 2002) and in multiple clinical trials evaluating child sexual 
behavior as a treatment outcome (e.g., Bonner, Walker, & Berliner, 
1999; Cohen & Mannarino, 1996; Silovsky, et al., 2007). Reliability 
and validity of the CSBI is well-established in numerous studies with 
large sample sizes (Friedrich, 1997; Friedrich, et al., 1991, Friedrich, 
et al., 1992; Friedrich, et al., 2001). 
B. Trauma Symptom Checklist for Young Children (TSCYC): The 
TSCYC is a 90-item caregiver -report measure for children between 
the ages of 3 and 12 (ages inclusive) that assesses for the presence of 
various trauma-related symptoms and presentations, such as 
posttraumatic stress, dissociation, and sexual concerns. In addition to 
capturing constructs such as caregiver-reported posttraumatic stress, 
the sexual concerns scale of the TSCYC will also serve as a secondary 
metric of caregiver-reported SBP. The TSCYC is a widely used 
measure in both clinical and research contexts (Milot, Ethier, St-
Laurent, & Provost, 2010; Overbeek, de Schipper, Lamers-
Winkelman, & Schuengel, 2013) and reliability and validity of the 
TSCYC is well-established (Briere, 2005; Briere, et al., 2001; 
Lanktree, et al., 2008)    
C. Trauma Symptom Checklist for Children (TSCC): The TSCC is a 
child self-report measure for children between the ages of 8-16 (ages 
inclusive) that assesses the same constructs as the TSCYC. Children 
younger than 8 do not complete the TSCC; as such, all children 
between the ages of 8-12 in the current project will complete the 

TSCC. Children are asked to report the frequency with which they 
experience each of 54 symptoms. In addition to providing scores for 
concerns such as posttraumatic stress, anger, and depression, the 
TSCC provides two scales assessing sexual thoughts and sexual 
anxiety. These scales provide a child’s self-reported index of sexual 
concerns. The TSCC is the most widely used self-report measure of 
child trauma-related outcomes, with frequent use in clinical and 
research contexts (Allen & Berliner, in press; Allen, Thorn, Gully, 
2015; Jonkman, Verlinden, Bolle, Boer, & Lindauer, 2013; Overbeek, 
et al., 2013) and the psychometric properties are well-researched 
(Briere, 1996; Crouch, Smith, Ezzell, & Saunders, 1999; Lanktree, et 
al., 2008).  
D. Behavior Assessment System for Children (BASC): The BASC is a 
commonly used broadband caregiver-report measure that assesses 
various forms of internalizing and externalizing concerns as well as 
adaptive behavior skills. Caregivers are asked to rate the frequency 
with which their children display each of 160 symptoms and 
behaviors. The BASC is commonly used in clinical and research 
contexts (Allen & Berliner, in press; Barbot, Hein, Luthar, & 
Grigorenko, 2014; Lochman, et al., 2015) and the psychometric 
properties of the BASC are well-established (Reynolds & Kamphaus, 
2004) 
E. Parenting Stress Index (PSI): The PSI-Short Form is a 36-item 
measure that a caregiver completes to rate his/her stress in relation to 
parenting a specific child. The PSI is a common research instrument, 
used in over 1,500 research studies to assess parenting stress, with 
many of these studies assessing the psychometric properties of the PSI 
(Abidin, 1995).  
2. First Study Assessment Session: This contact constitutes the first session 
where the child/caregiver dyad attends as a participant in the study. Either the 
research assistant or the PI will review the informed consent/assent form and 
obtain appropriate signatures. Following obtainment of informed 
consent/assent the following measures will be administered: 
A. Family Sexuality Index (FSI): The FSI was developed to assess 
various forms of expressed sexuality in the home, which is a strong 
correlate of SBP (Friedrich, 2007; Friedrich, et al., 2003). 
Psychometric evaluations of the FSI are not available at it is typically 
implemented and evaluated on an item-level basis. It is administered 
here in this project to evaluate the caregiver’s ability to reduce 
expressed sexuality in the home, which is directly addressed in the 
treatment. Administration of the FSI is standard practice at the TLC 
Clinic when SBP is identified as a presenting concern.                                                    
B. Safety Checklist (SC): The SC is designed to assess various 
caregiving and environmental variables that are linked to display of 
SBP among children (Friedrich, 2002, 2007). It is a semi-structured 
interview that assesses co-sleeping, co-bathing, family nudity, family 

sexuality, exposure to sexual behavior, and caregiver monitoring of the 
child. These concerns are directly targeted in the current protocol and 
the SC is designed to evaluate the caregiver’s ability to change these 
aspects of the family and environment. Psychometric analyses are not 
available at the SC is typically examined on an item-level basis. 
Administration of the SC is standard practice at the TLC Clinic when 
SBP is identified as a presenting concern.                                                                        
C. Kaufman Brief Intelligence Test (KBIT): The KBIT will be 
administered to both the child and caregiver. The KBIT is a widely 
used brief intelligence measure that is employed in over 1,000 
published research studies (Kaufman & Kaufman, 2004), and many of 
these studies have evaluated the psychometric properties of the 
measure. Collectively, these studies show that this brief measure 
correlates very strongly with full-length intelligence tests. 
Administration of the KBIT is standard practice at the TLC Clinic 
when concerns are raised about the cognitive ability of a child or 
caregiver.  
 
3. Treatment Sessions 1-4: Sessions will occur once per week and each session is 
45-50 minutes in duration. Sessions 1-4 will involve the following techniques: 
A. Session 1: Discussion of expressed sexuality in the family, review 
importance of increased monitoring of the child and discuss parenting 
techniques.  
B. Session 2: Define sexual behavior rules and consequences for 
breaking the rules. 
C. Session 3: Review the progress made in implementing the techniques 
from the previous two sessions. Refinement of the skills will be 
performed. 
D. Session 4: Review skills from previous sessions and discuss 
generalization to community settings. Practice application of the 
sexual behavior rules by discussing various scenarios. 
 
4. Second Study Assessment Session: Prior to completing additional treatment 
sessions, the child and caregiver will attend the second study assessment 
session. During this assessment session the research assistant will administer 
the following measures: 
A. CSBI 
B. TSCYC 
C. TSCC 
D. BASC 
E. PSI 
F. FSI 
G. SC 
 

5. Treatment Sessions 5-8: Sessions will occur once per week and each session is 
45-50 minutes in duration. Sessions 5-8 will involve the following techniques: 
A. Session 5: Engage the caregiver in a discussion about beliefs regarding 
sex and sexuality, their opinions of what the child should know about 
these topics, and what the caregiver considers “healthy.” 
B. Session 6: Provide education to the parents related to sexual behavior 
of children within the context of their beliefs obtained from the 
previous session. Review their approach to discussing these topics 
with the child and prepare them for discussing with the child in the 
next session. 
C. Session 7: Discuss with child what his or her questions are related to 
sex and sexuality. Discuss with caregiver how to respond to the 
questions the child raised. 
D. Session 8: Facilitate a discussion on sex and sexuality between the 
child and caregiver. This session will provide psychoeducation to the 
child.  
 
6. Third Study Assessment Session: Prior to completing additional treatment 
sessions, the child and caregiver will attend the third study assessment 
session. During this assessment session the research assistant will administer 
the following measures: 
A. CSBI 
B. TSCYC 
C. TSCC 
D. BASC 
E. PSI 
F. FSI 
G. SC 
 
7. Treatment Sessions 9-12: Sessions will occur once per week and each session 
is 45-50 minutes in duration. Sessions 9-12 will involve the following 
techniques: 
A. Session 9: Teach the child and caregiver impulse control skills focused 
on increasing tolerance and control of impulses. 
B. Session 10: Review skills from the previous session and refine as 
needed. 
C. Session 11: Teach the parent sexual abuse prevention skills. This 
includes reviewing what has already been discussed and what still 
needs to be addressed. These skills will be reviewed with the child. 
D. Session 12: Process the child’s desire to engage in sex (if present), 
examine the peer group and the role parents can play in encouraging 
positive peer relationships. 
 
8. Fourth Study Assessment Session: This session represents the post-treatment 
assessment and the child and caregiver are both expected to attend. During 

this assessment session the research assistant will administer the following 
measures: 
A. CSBI 
B. TSCYC 
C. TSCC 
D. BASC 
E. PSI 
F. FSI 
G. SC 
H. Caregiver Satisfaction Questionnaire (CSQ): The CSQ is a 
commonly used process outcome measure that asks caregivers to rate 
their treatment experience on various aspects of the clinical process. 
Psychometrics are not available as the CSQ is typically evaluated on 
an item-level basis.   
I. Therapeutic Alliance Scale for Children (TASC): The TASC is 
another commonly used process outcome measure that assesses the 
child’s perception of their relationship with the clinician. The TASC is 
typically evaluated on an item-level basis.  
 
9. Fifth Study Assessment Session: Approximately 4 weeks after the completion 
of treatment, children and caregivers will be expected to participate in a 
follow-up assessment to determine whether treatment improvements are 
maintained. This will constitute the participants’ final contact with the project. 
During this assessment session the research assistant will administer the 
following measures: 
A. CSBI 
B. TSCYC 
C. TSCC 
D. BASC 
E. PSI 
F. FSI 
G. SC 
 
7.2.2: Recording of sessions: All treatment sessions will be videorecorded and reviewed 
by the PI to ensure treatment fidelity. The clinician will identify which number sessions 
is being provided and the PI will watch the session to ensure that all treatment elements 
for that numbered session were delivered by the clinician. The research 
parent/caregiver and child will be seen only by the PI and the images will not be used 
outside of this assessment of treatment fidelity. As such, there is no data derived from 
this process that is attached to any participant/patient’s chart and sessions are not 
transcribed. No database using any confidential information or PHI is established for this 
purpose. All videorecordings are digital and use the standard system developed by the 
PSHMC IT department. All recordings are storedelectronically behind the PSHMC 
firewall. These recordings are not attached to patient charts and are deleted after being 
reviewed. Alternatively, depending on schedules, the PI may observe live sessions to 

monitor fidelity, in which case no recordings will occur. All cameras and recording 
equipment are already installed at the TLC Clinic and it is common TLC Clinic practice to 
record sessions for the purposes of training and clinician supervision. All patients are 
notified of this at the initial intake assessment.  
7.2.3: Treatment disrupting events: Clinicians will document any treatment disrupting 
events (e.g., inpatient admissions, protective services reports) in progress notes 
completed after each phone call and/or treatment session. These notes will be reviewed 
following completion of the patient’s participation in the project and such events will be 
coded for inclusion in analyses.  
 
4.3 
Duration of Participation 
 
 
Each participant is expected to complete the treatment protocol of 12 weekly sessions, 
in addition to each of the 5 assessment sessions. Pre-treatment and post-treatment 
assessments are standard practice at the TLC Clinic to evaluate progress; the assessments at 
each 4 week time point and the follow-up assessment are unique to this study.  
 
Statistical Plan 
 
Sample size determination 
 
A convenience sample of 15 child/caregiver dyads. Ethnic and gender composition will 
likely reflect the current composition of the TLC Clinic (45% White, 45% African-
American, 10% other ethnicities; 60% female, 40% male).  
 
The current project is designed to pilot the intervention for feasibility and functionality. 
This is within the normal limits of Phase 1 protocol development for behavioral 
interventions.  
 
Statistical methods 
 
Primary statistical analysis will be dependent on the variability and distributions of 
outcome metrics. It is anticipated that significant positive skew will be observed for many 
of the outcome metrics. Given this and the small sample size, nonparametric analyses 
will likely be employing, primarily the Friedman test. However, outcome metrics meeting 
assumptions of normality may be subjected to t-tests or repeated measures ANOVAs with 
potential modifications employed for derivation of confidence intervals (e.g., 
bootstrapping). Other general linear model analyses may be utilized depending on 
statistical diagnostic results.