Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220350
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-16
Brief Title:
Lupron Sex Offender Therapy
Sponsor:
Schober Justine MD
Organization:
Schober Justine MD
Study Overview
Official Title:
Leuprolide Acetate Suppresses Pedophilic Urges and Arousability
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compared cognitive-behavioral psychotherapy with leuprolide acetate LA to cognitive-behavioral psychotherapy with saline injections for 12 months Five white male pedophiles M age 50 years range 36-58 volunteered for a two-year study LA was administered by Depo injection 7 mg initially then 225 mg every 3 mos for 12 months followed by saline placebo Effects of LA on testosterone levels sexual interest preference by visual reaction time Abel Assessment penile tumescence Monarch PPG as well strong urges and masturbatory frequency to children polygraph were measured every three months Subjects were treated with weekly cognitive-behavioral psychotherapy On LA testosterone decreased to castrate levels Because of the suppression of testosterone physiologic arousal response as measured by penile plethysmography penile tumescence was significantly suppressed compared with baseline However sufficient response remained to detect pedophilic interest This pedophilic interest was also detected by visual reaction times All subjects self-reported a decrease in strong pedophilic urges and masturbation When asked about having pedophilic urges and masturbating to thoughts of children polygraph responses indicated subjects were not deceptive when they reported decreases On placebo testosterone and physiologic arousal eventually rose to baseline levels At baseline and on placebo subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph Interest preference as measured by Abel Assessment and Monarch PPG was generally unchanged throughout the study Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies urges and masturbation but did not change pedophilic interest during one year of therapy Deceptive responses by polygraph suggested that self-report was unreliable Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia Our study supports the supposition that modification of pedophilic behavior is possible LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense
Detailed Description:
Hormone therapy is aimed at modification of the basic sex drive whereas cognitive-behavioral psychotherapy targets cognitive processes that precede all events leading to pedophilic behavior Obsessioncompulsion and sex drive might affect the decision process Because of a suggested relationship between obsessive compulsive disorder and paraphilias SSRIs have been utilized Most reports have been documented from individual case studies or uncontrolled retrospective studies Kafka 2000
Reports of the efficacy of drug therapy for suppression of sexual drive and modification of behavior continue to emerge The anti-androgens MPA and CPA are the most widely used drugs They provide variable testosterone suppression dependent on dose LHRH inhibitors and GNRH agonists also provide profound testosterone suppression More recently triptorelin an agent similar to LA Rosler Wilztum 1998 and selective serotonin reuptake inhibitors SSRIs have also been investigated Raymond Grant Kim Colemen 2002 Stein Hollander Anthony Schneier Fallon Liebowitz Klein 1992
Despite recent advances in the use of testosterone-suppressing drugs for the treatment of pedophilia limited information is available in the form of well designed controlled objective studies The lack of standardized objective outcome measures has hampered objective assessment of efficacy of interventions for pedophilia Briken Hill Berner 2003 Hanson et al 2002 Marshall Barbaree 1990 A multi-disciplinary team of experts is needed to assess concurrent objective physiologic measures of response Though some results of treatment are promising a reliable well-tolerated approach that can be objectively monitored for efficacy is lacking
The specific aspects of behavior that are affected by therapy as well as the efficacy limitations and side effects of treatment need to be determined Briken Hill Berner 2003 Raymond Robinson Kraft Rittberg Coleman 2001 The present study assessed the impact of cognitive-behavioral psychotherapy alone versus cognitive-behavioral psychotherapy augmented with a potent testosterone-lowering drug LA for suppression of pedophilic urges and arousability The psychotherapy program comprised cognitive and behavioral therapy Objective assessments of sexual interest preference and physical arousal as well as sexual urges and masturbation were monitored before during and after therapy The research objectives were to explore the relationship between testosterone level and sexual interest preferences physiologic responses to sexual stimuli auditory and visual and self-reported sexual behaviors
METHOD Subjects Five men M age 50 years range 36-58 with a diagnosis of pedophilia American Psychiatric Association 1994 and who were out of denial were recruited for study Subjects were identified by a focus group of judges attorneys Probation and Parole officials representatives from the District Attorneys office and psychologists who were invited to a seminar regarding the Lupron Project After potential subjects were identified the Principal Investigator screened case histories to determine eligibility for study inclusion Table 1 These potential subjects were contacted by the Principal Investigator They were interviewed informed of the study and invited to participate Three additional subjects were screened but excluded These included one psychotic adult one adolescent and one elderly nonerectile adult The study was conducted during a two-year period in a medical research center in north western Pennsylvania The study was reviewed and approved by the local Institutional Review Board All subjects provided informed consent Participation was voluntary and not a condition of probation or parole The subjects were informed that they would receive either a drug or placebo without an indication of duration of dose the sequence nor if a sequence would occur The subjects did not know one another They lived in diverse geographical locations and their only contact was during group cognitive-behavioral psychotherapy
IQ data were available for four of the five participants all of whom had normal IQs The fifth participant on whom IQ data were unavailable was not considered to be intellectually impaired Four of the five participants reported having been sexually abused during their childhood Each subject was more than 16 years old and at least five years older than the victim when offending was initiated Table II At baseline the self-reported numbers of victims for the five subjects totaled 329
Four of five had served lengthy prison sentences M 78 years for conviction of sexual crimes All subjects had previous treatment in penitentiary or community-based sexual offender programs Two had a history of major depression and two had a prior diagnosis of alcoholism Two subjects reported bisexual pedophilic preference two exclusively heterosexual preference and one an exclusively homosexual preference At baseline and throughout the study all five subjects met the DSM-IV criteria for pedophilia as well as antisocial personality disorder American Psychiatric Association 1994 Berger Berner Bolterauer Gutierrez Berger 1999
Study Design Five male pedophiles entered a prospective repeated measures nonrandomized masked study All subjects and investigators except the Principal Investigator PI Project Director and Study Coordinator were masked The PI administered the drug or placebo the PI and Project Director designed the study and were cognizant of the dosing schedule and the Coordinator was responsible for supply of study drug However the PI Project Director and Coordinator were not involved in direct data collection or evaluation of the subjects Each subject served as his own control Subjects received weekly cognitive-behavioral psychotherapy for 24 months and LA depot injection 75 mg at baseline and 225 mg at months 1 4 7 and 10 Flutamide 250 mg TID for 14 days was only administered with the first injection
Flutamide is an acetanilid nonsteroidal orally active anti-androgen that exerts its anti-androgenic action by inhibiting androgen uptake andor by inhibiting nuclear binding of androgen in target tissues or both Flutamide has been demonstrated to interfere with testosterone at the cellular level This can complement medical castration achieved with LHRH agonists that suppress testicular androgen production by inhibiting luteinizing hormone secretion Brogden 1989
After the initial injection subjects were sequestered for one week for community protection After one year of therapy LA was discontinued and saline placebo substituted At baseline one month after initiation of LA therapy and then at 3-month intervals subjects underwent Abel Assessment Monarch Penile Plethysmography PPG polygraph physical examinations laboratory studies radiology studies and psychological testing
Abel Assessment Abel Screening Inc Atlanta Georgia Abel Assessment a combination of self-report and visual reaction time VRT was utilized according to manufacturers instructions Abel Screening Inc Atlanta Georgia Assessments were conducted by a trained clinical staff member Abel Huffman Warberg Holland 1998 Letourneau 2002 A questionnaire was also administered The combined questionnaire and VRT results included evaluation for 21 sexual interests including paraphilias
To assess VRT the amount of time a subject viewed a picture a slide projector was used to present still images of models onto a 12-inch computer screen Models were clothed generally in swimsuits and none were in sexual positions Twenty-one stimulus categories representing 21 potential sexual interests with approximately seven slides in each category were viewed by the subject Slides depicted Caucasian and African American males and females comprising preschool and school-age children adolescents and adults
An examiner met individually with each subject and instructed him on advancing and rating the slides The subject viewed the slides in a dimly lit quiet cubicle After a practice session the subject completed the VRT in private After viewing each slide participants rated each slide on a scale from 1 extremely sexually repulsive to 7 extremely sexually interesting A computer recorded the amount of time a subject viewed and rated each slide Data from the second viewing time were utilized by Abel Screening Inc to compute the z-scores These were provided to the investigator in graph form with a score for self-reported interest Per manufacturers instructions the Abel rule of thirds was utilized to define the predominant sexual preference Because of the large number of sexual preference choices generated by the Abel method a modification was adopted For this study predominant sexual preference was defined as a relative visual reaction time z-score 1 SD The number of times each stimulus was 1 SD was recorded If only one or none of the SDs were 1 the two highest scores were recorded This modification resulted in an objective measure of only those selections that stimulated the longest VRT Table III
To illustrate the difference in the modified Abel and the Abel Methods of Thirds subject 1 self- reported an interest in adolescent and adult males His known victims were boys aged 12 to 17 Using the Abel Method of Thirds per manufacturer instructions the interest preferences included young and adolescent females and young adolescent and adult males Using the modified Abel the selection was truncated to adolescent and adult males the exact interest preferences self-reported by the patient Table III
Z-scores for each stimulus set were reported at baseline on LA and off LA respectively Assessments were compared before during and after treatment to determine if VRT associated with pedophilic interest preferences changed with treatment
Given that lowering testosterone to castrate levels would affect penile responsiveness and potentially affect the Monarch PPG monitoring the Abel Assessment was incorporated into the study with the anticipation that pedophilic sexual preference could still be potentially detected by visual reaction time
Monarch PPG Behavioral Technology Inc Salt Lake City Utah The Monarch Adult Projective Audio Visual Set Version 5 Salt Lake City Utah was a commercially available set of standardized stimulus materials that was used to assess all subjects The stimuli contained audio and visual depictions of males and females comprising preschool and grammar school children adolescents and adults The audio scripts were based on a projective rather than explicit portrayal of sexual activity Unlike most other PPG visual stimuli the set contained clothed pictures of children all child models were shown in bathing suits or underwear No lewd or provocative poses were presented Byrne 2000
During this procedure the subject was seated in a reclining chair located in a private room equipped with an intercom The audiovisual stimulus materials were presented via headphones on a 14-inch television monitor Stimulus presentation and collection of penile galvanic skin response GSR and respiration data were recorded and coordinated by a microprocessor-based Monarch Data Recording Device DRD Behavioral Technology Inc Salt Lake City Utah
Penile circumference changes were measured using an indium gallium gauge supplied by Behavioral Technology Inc The signal from the indium gallium gauge was amplified by 1000 data retrieval was set at a rate of 10 samples per second Each penile gauge was calibrated to a full range of 30 cm before each assessment to ensure that the correlation between circumference and deflection was linear GSR electrodes and respiration belts were also used for deterrence and potential detection of faking or suppression attempts
Data from the assessment were compiled and analyzed using Monarch Adult Male Software Version 322f This software guided the collection management and initial analysis of the PPG data The software analyzed the PPG data and provided maximum scores and area- under-the-curve scores for each of the 22 segments of the test A maximum penile tumescence score was calculated for each subject for each category of stimuli For the purposes of this study maximum penile tumescence was defined as any response above 20 points 60 cm which is 20 of the calibration of the gauge Murphy and Barbaree 1994 argued that a minimum level for significance was 20 To meet this requirement a response was considered to be significant if it was at least 20100-scaled units from the beginning of the stimulus detumesced level Kuban Barbaree and Blanchard 1999 also suggested that this criterion was conservative Subjects PPG calibration and projected full-scale responding were set to 30 cm Thus the cutoff of 20 points for significant responding falls within the 20 minimum criterion for significant responding The subjects PPG calibration and projected full-scale responding were set to 30 cm circumference A repeated measures ANOVA was performed on the PPG data to assess significant changes in arousal level throughout the study 05 To assess sexual preferences raw data for each subject were transformed to z-scores The z-scores for each stimulus were recorded at baseline on LA and off LA All the responses 1 SD or the two highest responses were recorded Finally a subjects classification as pedophilicnonpedophilic was determined by using a deviance differential Harris Rice Quinsey Chaplin Earls 1992 This was calculated using z-score data and taking the highest response to adults male and female segments minus the highest response to infants and children male or female preschool or grammar school age The adolescent segment was excluded from analysis For the purposes of data analysis deviance differential scores greater than 0 were classified as nonpedophilic and scores less than 0 as pedophilic A deviance differential of O would mean that the subject was just as aroused to children as to adults
All subjects were assessed at baseline One subject 1 did not respond to a level of clinical significance 20 points Further inspection revealed that this client did not obtain a significant response at any point during the two-year study He was removed from the analysis of the PPG data repeated measures ANOVA because low level data generated from a circumferential PPG transducer were not considered reliable Kuban et al 1999 Barbaree Mewhort 1994
Polygraph
An Axciton Computerized Polygraph System Axciton Systems Houston Texas and the Lafayette Instrument LX-4000 Lafayette Instrument Co Lafayette Indiana were utilized The examiner was certified by the Colorado Sex Offender Management Board For purposes of score reliability and validity confirmation the results were both scored by hand and scored using the Johns Hopkins Applied Physics Laboratory Polyscore computer scoring algorithm Heil Ahlmeyer Simons English 1999 Hand scoring is recognized by the American Polygraph Association as the most accurate and reliable method of scoring It was the only method used to evaluate the data The algorithm was used as a quality control check of the hand scoring method Subjects provided a separate informed consent before the first polygraph examination The test was administered in a private office The examination took an average of two hours Subjects were tested every three months Polygraph was standardized by an American Polygraph Association approved test procedure and was administered by a single experienced examiner who was blinded to the dosing protocol The polygraph examination process contained pretest and posttest components The examiner worked closely with the psychotherapist in developing appropriate polygraph questions for confirmation of the disclosed number of victims and offenses discovery of new offenses and or compliance with study conditions This study examined past victim and offense admissions data as well as responses evaluating 30 paraphilias Table IV The pretest established which questions the examiner would ask based on the subjects self report of new admissions of past offending or the absence of accountability statements for known offending behaviors identified in prison histories The subjects cardiovascular respiratory and galvanic skin resistance were assessed in response to three specific key questions
1 In the past three months have you masturbated to sexual thoughts about anyone under the age of 18
2 In the past three months have you purposely withheld important sexual information from your therapist
3 In the past three months have you had strong urges to initiate sexual contact with anyone under 18 years old No consequences were imposed for deceptive responses The therapist and polygrapher worked closely and debriefed the subject after each assessment to identify areas for counseling behaviors to be monitored and issues detected on polygraph
Cognitive-behavioral psychotherapy The psychotherapy program comprised cognitive and behavioral therapy The weekly sessions were co-facilitated by two therapists After establishing the rules for group therapy psychotherapists guided participants through a basic group curriculum that included breaking down defense mechanisms identifying the typology of sex offenders and discussing the effects of sexual abuse on victims The counseling component involved insight-oriented cognitive-behavioral psychotherapy This provided a dynamic understanding of unconscious conflicts and interpersonal issues as they related to each participants offense cycle Relapse prevention plans were constructed with and for each participant This self-controlled program was designed to teach offenders how to recognize and intervene when they were behaving in a manner that would lead to a re-offense Relapse prevention enabled the individual to maintain the newly adopted behavior pattern such as refraining from deviant thoughts and actions The relapse prevention plans described red flags offense cycles interventions and changes in thoughts feelings attitudes and behaviors
Psychopathology The Hare Psychopathy Checklist-Revised PCL-R was utilized to assess subjects psychopathology Hare 1998 The Minnesota Sex Offender Screening Tool-Revised MnSOST-R identified the most violent offenders and those offenders likely to re-offend Epperson et al 1999 The Static-99 another sexual offender risk assessment measured long-term risk potential for child molesters Hanson Thornton 1999 The Yale-Brown Obsessive Compulsive Scale Y-BOCS was utilized because of an inferred relationship between obsessive compulsive disorder and sexual paraphilias Goodman et al 1989
Reports of the efficacy of drug therapy for suppression of sexual drive and modification of behavior continue to emerge The anti-androgens MPA and CPA are the most widely used drugs They provide variable testosterone suppression dependent on dose LHRH inhibitors and GNRH agonists also provide profound testosterone suppression More recently triptorelin an agent similar to LA Rosler Wilztum 1998 and selective serotonin reuptake inhibitors SSRIs have also been investigated Raymond Grant Kim Colemen 2002 Stein Hollander Anthony Schneier Fallon Liebowitz Klein 1992
Despite recent advances in the use of testosterone-suppressing drugs for the treatment of pedophilia limited information is available in the form of well designed controlled objective studies The lack of standardized objective outcome measures has hampered objective assessment of efficacy of interventions for pedophilia Briken Hill Berner 2003 Hanson et al 2002 Marshall Barbaree 1990 A multi-disciplinary team of experts is needed to assess concurrent objective physiologic measures of response Though some results of treatment are promising a reliable well-tolerated approach that can be objectively monitored for efficacy is lacking
The specific aspects of behavior that are affected by therapy as well as the efficacy limitations and side effects of treatment need to be determined Briken Hill Berner 2003 Raymond Robinson Kraft Rittberg Coleman 2001 The present study assessed the impact of cognitive-behavioral psychotherapy alone versus cognitive-behavioral psychotherapy augmented with a potent testosterone-lowering drug LA for suppression of pedophilic urges and arousability The psychotherapy program comprised cognitive and behavioral therapy Objective assessments of sexual interest preference and physical arousal as well as sexual urges and masturbation were monitored before during and after therapy The research objectives were to explore the relationship between testosterone level and sexual interest preferences physiologic responses to sexual stimuli auditory and visual and self-reported sexual behaviors
METHOD Subjects Five men M age 50 years range 36-58 with a diagnosis of pedophilia American Psychiatric Association 1994 and who were out of denial were recruited for study Subjects were identified by a focus group of judges attorneys Probation and Parole officials representatives from the District Attorneys office and psychologists who were invited to a seminar regarding the Lupron Project After potential subjects were identified the Principal Investigator screened case histories to determine eligibility for study inclusion Table 1 These potential subjects were contacted by the Principal Investigator They were interviewed informed of the study and invited to participate Three additional subjects were screened but excluded These included one psychotic adult one adolescent and one elderly nonerectile adult The study was conducted during a two-year period in a medical research center in north western Pennsylvania The study was reviewed and approved by the local Institutional Review Board All subjects provided informed consent Participation was voluntary and not a condition of probation or parole The subjects were informed that they would receive either a drug or placebo without an indication of duration of dose the sequence nor if a sequence would occur The subjects did not know one another They lived in diverse geographical locations and their only contact was during group cognitive-behavioral psychotherapy
IQ data were available for four of the five participants all of whom had normal IQs The fifth participant on whom IQ data were unavailable was not considered to be intellectually impaired Four of the five participants reported having been sexually abused during their childhood Each subject was more than 16 years old and at least five years older than the victim when offending was initiated Table II At baseline the self-reported numbers of victims for the five subjects totaled 329
Four of five had served lengthy prison sentences M 78 years for conviction of sexual crimes All subjects had previous treatment in penitentiary or community-based sexual offender programs Two had a history of major depression and two had a prior diagnosis of alcoholism Two subjects reported bisexual pedophilic preference two exclusively heterosexual preference and one an exclusively homosexual preference At baseline and throughout the study all five subjects met the DSM-IV criteria for pedophilia as well as antisocial personality disorder American Psychiatric Association 1994 Berger Berner Bolterauer Gutierrez Berger 1999
Study Design Five male pedophiles entered a prospective repeated measures nonrandomized masked study All subjects and investigators except the Principal Investigator PI Project Director and Study Coordinator were masked The PI administered the drug or placebo the PI and Project Director designed the study and were cognizant of the dosing schedule and the Coordinator was responsible for supply of study drug However the PI Project Director and Coordinator were not involved in direct data collection or evaluation of the subjects Each subject served as his own control Subjects received weekly cognitive-behavioral psychotherapy for 24 months and LA depot injection 75 mg at baseline and 225 mg at months 1 4 7 and 10 Flutamide 250 mg TID for 14 days was only administered with the first injection
Flutamide is an acetanilid nonsteroidal orally active anti-androgen that exerts its anti-androgenic action by inhibiting androgen uptake andor by inhibiting nuclear binding of androgen in target tissues or both Flutamide has been demonstrated to interfere with testosterone at the cellular level This can complement medical castration achieved with LHRH agonists that suppress testicular androgen production by inhibiting luteinizing hormone secretion Brogden 1989
After the initial injection subjects were sequestered for one week for community protection After one year of therapy LA was discontinued and saline placebo substituted At baseline one month after initiation of LA therapy and then at 3-month intervals subjects underwent Abel Assessment Monarch Penile Plethysmography PPG polygraph physical examinations laboratory studies radiology studies and psychological testing
Abel Assessment Abel Screening Inc Atlanta Georgia Abel Assessment a combination of self-report and visual reaction time VRT was utilized according to manufacturers instructions Abel Screening Inc Atlanta Georgia Assessments were conducted by a trained clinical staff member Abel Huffman Warberg Holland 1998 Letourneau 2002 A questionnaire was also administered The combined questionnaire and VRT results included evaluation for 21 sexual interests including paraphilias
To assess VRT the amount of time a subject viewed a picture a slide projector was used to present still images of models onto a 12-inch computer screen Models were clothed generally in swimsuits and none were in sexual positions Twenty-one stimulus categories representing 21 potential sexual interests with approximately seven slides in each category were viewed by the subject Slides depicted Caucasian and African American males and females comprising preschool and school-age children adolescents and adults
An examiner met individually with each subject and instructed him on advancing and rating the slides The subject viewed the slides in a dimly lit quiet cubicle After a practice session the subject completed the VRT in private After viewing each slide participants rated each slide on a scale from 1 extremely sexually repulsive to 7 extremely sexually interesting A computer recorded the amount of time a subject viewed and rated each slide Data from the second viewing time were utilized by Abel Screening Inc to compute the z-scores These were provided to the investigator in graph form with a score for self-reported interest Per manufacturers instructions the Abel rule of thirds was utilized to define the predominant sexual preference Because of the large number of sexual preference choices generated by the Abel method a modification was adopted For this study predominant sexual preference was defined as a relative visual reaction time z-score 1 SD The number of times each stimulus was 1 SD was recorded If only one or none of the SDs were 1 the two highest scores were recorded This modification resulted in an objective measure of only those selections that stimulated the longest VRT Table III
To illustrate the difference in the modified Abel and the Abel Methods of Thirds subject 1 self- reported an interest in adolescent and adult males His known victims were boys aged 12 to 17 Using the Abel Method of Thirds per manufacturer instructions the interest preferences included young and adolescent females and young adolescent and adult males Using the modified Abel the selection was truncated to adolescent and adult males the exact interest preferences self-reported by the patient Table III
Z-scores for each stimulus set were reported at baseline on LA and off LA respectively Assessments were compared before during and after treatment to determine if VRT associated with pedophilic interest preferences changed with treatment
Given that lowering testosterone to castrate levels would affect penile responsiveness and potentially affect the Monarch PPG monitoring the Abel Assessment was incorporated into the study with the anticipation that pedophilic sexual preference could still be potentially detected by visual reaction time
Monarch PPG Behavioral Technology Inc Salt Lake City Utah The Monarch Adult Projective Audio Visual Set Version 5 Salt Lake City Utah was a commercially available set of standardized stimulus materials that was used to assess all subjects The stimuli contained audio and visual depictions of males and females comprising preschool and grammar school children adolescents and adults The audio scripts were based on a projective rather than explicit portrayal of sexual activity Unlike most other PPG visual stimuli the set contained clothed pictures of children all child models were shown in bathing suits or underwear No lewd or provocative poses were presented Byrne 2000
During this procedure the subject was seated in a reclining chair located in a private room equipped with an intercom The audiovisual stimulus materials were presented via headphones on a 14-inch television monitor Stimulus presentation and collection of penile galvanic skin response GSR and respiration data were recorded and coordinated by a microprocessor-based Monarch Data Recording Device DRD Behavioral Technology Inc Salt Lake City Utah
Penile circumference changes were measured using an indium gallium gauge supplied by Behavioral Technology Inc The signal from the indium gallium gauge was amplified by 1000 data retrieval was set at a rate of 10 samples per second Each penile gauge was calibrated to a full range of 30 cm before each assessment to ensure that the correlation between circumference and deflection was linear GSR electrodes and respiration belts were also used for deterrence and potential detection of faking or suppression attempts
Data from the assessment were compiled and analyzed using Monarch Adult Male Software Version 322f This software guided the collection management and initial analysis of the PPG data The software analyzed the PPG data and provided maximum scores and area- under-the-curve scores for each of the 22 segments of the test A maximum penile tumescence score was calculated for each subject for each category of stimuli For the purposes of this study maximum penile tumescence was defined as any response above 20 points 60 cm which is 20 of the calibration of the gauge Murphy and Barbaree 1994 argued that a minimum level for significance was 20 To meet this requirement a response was considered to be significant if it was at least 20100-scaled units from the beginning of the stimulus detumesced level Kuban Barbaree and Blanchard 1999 also suggested that this criterion was conservative Subjects PPG calibration and projected full-scale responding were set to 30 cm Thus the cutoff of 20 points for significant responding falls within the 20 minimum criterion for significant responding The subjects PPG calibration and projected full-scale responding were set to 30 cm circumference A repeated measures ANOVA was performed on the PPG data to assess significant changes in arousal level throughout the study 05 To assess sexual preferences raw data for each subject were transformed to z-scores The z-scores for each stimulus were recorded at baseline on LA and off LA All the responses 1 SD or the two highest responses were recorded Finally a subjects classification as pedophilicnonpedophilic was determined by using a deviance differential Harris Rice Quinsey Chaplin Earls 1992 This was calculated using z-score data and taking the highest response to adults male and female segments minus the highest response to infants and children male or female preschool or grammar school age The adolescent segment was excluded from analysis For the purposes of data analysis deviance differential scores greater than 0 were classified as nonpedophilic and scores less than 0 as pedophilic A deviance differential of O would mean that the subject was just as aroused to children as to adults
All subjects were assessed at baseline One subject 1 did not respond to a level of clinical significance 20 points Further inspection revealed that this client did not obtain a significant response at any point during the two-year study He was removed from the analysis of the PPG data repeated measures ANOVA because low level data generated from a circumferential PPG transducer were not considered reliable Kuban et al 1999 Barbaree Mewhort 1994
Polygraph
An Axciton Computerized Polygraph System Axciton Systems Houston Texas and the Lafayette Instrument LX-4000 Lafayette Instrument Co Lafayette Indiana were utilized The examiner was certified by the Colorado Sex Offender Management Board For purposes of score reliability and validity confirmation the results were both scored by hand and scored using the Johns Hopkins Applied Physics Laboratory Polyscore computer scoring algorithm Heil Ahlmeyer Simons English 1999 Hand scoring is recognized by the American Polygraph Association as the most accurate and reliable method of scoring It was the only method used to evaluate the data The algorithm was used as a quality control check of the hand scoring method Subjects provided a separate informed consent before the first polygraph examination The test was administered in a private office The examination took an average of two hours Subjects were tested every three months Polygraph was standardized by an American Polygraph Association approved test procedure and was administered by a single experienced examiner who was blinded to the dosing protocol The polygraph examination process contained pretest and posttest components The examiner worked closely with the psychotherapist in developing appropriate polygraph questions for confirmation of the disclosed number of victims and offenses discovery of new offenses and or compliance with study conditions This study examined past victim and offense admissions data as well as responses evaluating 30 paraphilias Table IV The pretest established which questions the examiner would ask based on the subjects self report of new admissions of past offending or the absence of accountability statements for known offending behaviors identified in prison histories The subjects cardiovascular respiratory and galvanic skin resistance were assessed in response to three specific key questions
1 In the past three months have you masturbated to sexual thoughts about anyone under the age of 18
2 In the past three months have you purposely withheld important sexual information from your therapist
3 In the past three months have you had strong urges to initiate sexual contact with anyone under 18 years old No consequences were imposed for deceptive responses The therapist and polygrapher worked closely and debriefed the subject after each assessment to identify areas for counseling behaviors to be monitored and issues detected on polygraph
Cognitive-behavioral psychotherapy The psychotherapy program comprised cognitive and behavioral therapy The weekly sessions were co-facilitated by two therapists After establishing the rules for group therapy psychotherapists guided participants through a basic group curriculum that included breaking down defense mechanisms identifying the typology of sex offenders and discussing the effects of sexual abuse on victims The counseling component involved insight-oriented cognitive-behavioral psychotherapy This provided a dynamic understanding of unconscious conflicts and interpersonal issues as they related to each participants offense cycle Relapse prevention plans were constructed with and for each participant This self-controlled program was designed to teach offenders how to recognize and intervene when they were behaving in a manner that would lead to a re-offense Relapse prevention enabled the individual to maintain the newly adopted behavior pattern such as refraining from deviant thoughts and actions The relapse prevention plans described red flags offense cycles interventions and changes in thoughts feelings attitudes and behaviors
Psychopathology The Hare Psychopathy Checklist-Revised PCL-R was utilized to assess subjects psychopathology Hare 1998 The Minnesota Sex Offender Screening Tool-Revised MnSOST-R identified the most violent offenders and those offenders likely to re-offend Epperson et al 1999 The Static-99 another sexual offender risk assessment measured long-term risk potential for child molesters Hanson Thornton 1999 The Yale-Brown Obsessive Compulsive Scale Y-BOCS was utilized because of an inferred relationship between obsessive compulsive disorder and sexual paraphilias Goodman et al 1989
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TAP Pharmaceuticals | None | None | None |