Trial Outcomes & Findings for Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements (NCT NCT02493088)

Results Overview

Recruitment status

COMPLETED

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2017-04-14

Participant Flow

March 3 2015 to May 30 2015 Rochefort prison

Patient with a negative psychopathy score at PCL-R were excluded A patient was transfered before assignment

Participant milestones

Participant milestones
Measure	Antisocial Personality Individuals Diagnosed with Antisocial Personality Disorder Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antisocial Personality n=11 Participants Individuals Diagnosed with Antisocial Personality Disorder Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
Age, Continuous	28 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment France	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Antisocial Personality n=11 Participants Individuals Diagnosed with Antisocial Personality Disorder Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.	9 participants

SECONDARY outcome

Timeframe: 6 months

Collected contextual elements were : * Disorders in the institution (with a caregiver, frustration with the rules) * Difficulty / frustration with an inmate * Difficulty / frustration with the entourage * Consumption of alcohol or other toxic substances * Steps in the judicial process (refusal of parole, reduction of sentence ...) * Psychiatric symptoms: delirious, sleep disorders, nightmares The numerator for the percentage calculated is the number of aberrant driving behaviors with contextual element. The denominator for the percentage calculated is the total number of aberrant driving behaviors (with and without contextual element)

Outcome measures

Outcome measures
Measure	Antisocial Personality n=46 Number of aberrant driving behaviors Individuals Diagnosed with Antisocial Personality Disorder Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors	67.4 percent of aberrant driving behaviors Interval 53.8 to 80.9

SECONDARY outcome

Timeframe: 6 months

Auto-aggressive: attempted suicide, any gesture of mutilation (scarification, punching in a wall, etc.) Aggressive: rixes with fellow inmates or prison staff, attempted homicides, sexual assaults, etc. Other hetero transgression: Failure to comply with the rules of the institution, illegal entry of illicit objects into the establishment, consumption of toxic materials, destruction of property, etc.

Outcome measures

Outcome measures
Measure	Antisocial Personality n=11 Participants Individuals Diagnosed with Antisocial Personality Disorder Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression) auto-aggressive	0 number of observed situations
Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression) aggressive	15 number of observed situations
Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression) other hetero transgression	31 number of observed situations

Adverse Events

Antisocial Personality

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Antisocial Personality n=11 participants at risk Individuals Diagnosed with Antisocial Personality Disorder Aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder were recorded during the study. Adverse events were not related to the study. Recorded adverse events were situations where subjects were harmed and required medical intervention.
Injury, poisoning and procedural complications Brain Contusion	9.1% 1/11 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Contusions	9.1% 1/11 • Number of events 1 • 6 months

Additional Information

Dr Jérôme SAINT-MARTIN, study director

Groupe Hospitalier de la Rochelle Ré Aunis

Phone: +33 5 46 45 66 03

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place