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Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data

Primary Purpose

Psychopathic Personality Trait

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Trauma Focused-Cognitive Behavior Therapy
Sponsored by
Universidad Nacional Autonoma de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychopathic Personality Trait focused on measuring children maltreatment, neurodevelopmental psychopathy, post-traumatic stress disorder, neuroimaging, brain reorganization

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For maltreated children group (MC) Ages between 7 to 12 years old History of trauma or abuse Symptoms of Post traumatic stress disorder Symptoms of anxiety For healthy control (HC) Ages between 7 to 12 years old No history of trauma or abuse Absence or low symptoms of Post Traumatic Stress Disorder Absence or low symptoms of anxiety Exclusion Criteria: • Any neurodevelopmental, medical condition or risk factor other than maltreatment.

Sites / Locations

  • Facultad de Psicología UNAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maltreated children

Healthy Control group

Arm Description

The Maltreated Children group was assessed before and after a psychological intervention using clinical scales (anxiety, depression, post-traumatic stress disorder and Callous unemotional traits) and an emotion paradigm through functional magnetic resonance imaging (fMRI). The psychological intervention implemented with the maltreated group was the Trauma Focused-Cognitive Behavior Therapy. For this study, 12 to 16 sessions of 60-90 min each, were implemented once a week for 4 months. 14 out of 15 maltreated children completed the TF-CBT units and one week after that, they underwent the post-treatment assessment.

This group did not have any records of maltreatment. They were assessed using clinical scales (anxiety, depression, post-traumatic stress disorder and Callous unemotional traits) and an emotion paradigm through functional magnetic resonance imaging (fMRI). Their scores and brain images were compared with the maltreatment group before this group underwent psychological treatment.

Outcomes

Primary Outcome Measures

Correlations between brain regions and clinical traits after psychological treatment
Post treatment scores on callous-unemotional traits (possible scores from 0 - to 43), depression (possible scores from 0 to 274, and PTSD (possible scores from 0 - 17) will be correlated with brain activation changes post treatment in regions of interest. Lower scores in clinical scales after treatment means a lower clinical symptom. Brain regios activations will be obtained with a fmri scan. BOLD response will be measured in each brain region.

Secondary Outcome Measures

Clinical differences at pre treatment between maltreatment group and healthy control
Characteristics of clinical traits before treatment in maltreatment and healthy control group.
Clinical improvement after treatment
A Reliable Change Index >1.96 will be obtained fron callous-unemotional, depression and PTSD scales of each participant. This index indicates a significant clinical improvement.

Full Information

First Posted
August 23, 2023
Last Updated
August 31, 2023
Sponsor
Universidad Nacional Autonoma de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT06028620
Brief Title
Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data
Official Title
Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Autonoma de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial was to learn about the effect of maltreatment on psychological and brain characteristics in a group of children. The main question it aims to answer are: which are the clinical characteristics of maltreated children before and after a psychological intervention? what changes in brain emotional processing after a psychological intervention? and what is the effect of serotonin transporter variants after a psychological therapy? Participants were assessed before and after intervention with: clinical measures of anxiety, depression post-traumatic stress and callous-unemotional traits functional neuroimaging techniques to measure brain activity. A sample of buccal epithelial cells to obtain information on serotonin transporter. Researchers will compare maltreated children with a group on non-maltreated children to see if there are differences on psychological characteristics and on brain activity before treatment.
Detailed Description
Participants Twenty-five children who suffered child abuse were initially referred by a non-governmental shelter in Mexico City. Children were removed from their homes and placed at the shelter because one or both parents were undergoing judicial processes for various crimes, including child abuse. None of the children had ever received psychological therapy because the shelter did not have a protocol for psychological intervention. After a thorough search for the most appropriate therapy, the TF-CBT was chosen. The information was shared with the shelter administrative board. Once authorities and health professionals at the shelter were informed about the aim of the study, they agreed about the appropriateness of the intervention. A group of trained psychologists would apply the TF-CBT as part of the research protocol. Only children who met the inclusion criteria would participate. Parents or primary caregivers gave their informed written consent for their children to participate in the study. Ethical approval of the study was granted, and the research was performed in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). The final sample consisted of an experimental group of 14 MC which included 4 boys and 10 girls (mean age = 8.77 years old, S.D.=1.83), who had experienced a positive history of different types of trauma, and a control group of 10 HC from the general population who were developing normally and were age-matched to the MC (4 boys and 6 girls) (mean age = 9.57 years old, S.D. = 1.91). They were recruited through an advertisement placed at the Faculty of Psychology, National Autonomous University of Mexico (UNAM) or by direct referral from parents of previous participants in other studies. All were residents of Mexico City. The study protocol was conducted with the approval of the UNAM Institutional Review Board. Clinical scales A comprehensive clinical battery was used to assess all participants through the administration of the following assessment tools: The Child Depression Inventory (CDI) Spanish version (Del Barrio & Carrasco, 2004). The Spence Children's Anxiety Scale (SCAS) standardized on a sample of Mexican children by Hernández et al (Hernández-Guzmán et al., 2010), the Child PTSD Symptom Scale (CPSS) Spanish version (Bustos et al., 2009), and the Inventory of Callous Unemotional Traits (ICU) Spanish version (López-Romero et al., 2015) including three subscales for callousness, uncaring, and unemotional (Frick, 2004). Procedure The MC group was assessed before and after the implementation of Trauma Focused-Cognitive Behavior Therapy (TF-CBT) using clinical scales and an emotion paradigm through functional magnetic resonance imaging (fMRI). The HC group was also assessed and scanned twice. Of the total sample, 14 MC completed the TF-CBT modules and came in for their post-treatment assessment session. In addition, the 10 HC who, according to their parents, had not completed any type of psychological intervention during those 4 months, and still met the inclusion criteria for the initial control group were selected and returned for their post-evaluation session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychopathic Personality Trait
Keywords
children maltreatment, neurodevelopmental psychopathy, post-traumatic stress disorder, neuroimaging, brain reorganization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maltreated children
Arm Type
Experimental
Arm Description
The Maltreated Children group was assessed before and after a psychological intervention using clinical scales (anxiety, depression, post-traumatic stress disorder and Callous unemotional traits) and an emotion paradigm through functional magnetic resonance imaging (fMRI). The psychological intervention implemented with the maltreated group was the Trauma Focused-Cognitive Behavior Therapy. For this study, 12 to 16 sessions of 60-90 min each, were implemented once a week for 4 months. 14 out of 15 maltreated children completed the TF-CBT units and one week after that, they underwent the post-treatment assessment.
Arm Title
Healthy Control group
Arm Type
No Intervention
Arm Description
This group did not have any records of maltreatment. They were assessed using clinical scales (anxiety, depression, post-traumatic stress disorder and Callous unemotional traits) and an emotion paradigm through functional magnetic resonance imaging (fMRI). Their scores and brain images were compared with the maltreatment group before this group underwent psychological treatment.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Focused-Cognitive Behavior Therapy
Intervention Description
TF-CBT consisted of 8 units in which different issues realted to trauma are reviewed. Units are: psychoeducation and parenting skills, relaxation techniques, affective expression and regulation, cognitive coping and processing, trauma narrative and processing, in vivo exposure, co-joint sessions and enhancing safety and future growth.
Primary Outcome Measure Information:
Title
Correlations between brain regions and clinical traits after psychological treatment
Description
Post treatment scores on callous-unemotional traits (possible scores from 0 - to 43), depression (possible scores from 0 to 274, and PTSD (possible scores from 0 - 17) will be correlated with brain activation changes post treatment in regions of interest. Lower scores in clinical scales after treatment means a lower clinical symptom. Brain regios activations will be obtained with a fmri scan. BOLD response will be measured in each brain region.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical differences at pre treatment between maltreatment group and healthy control
Description
Characteristics of clinical traits before treatment in maltreatment and healthy control group.
Time Frame
1 month
Title
Clinical improvement after treatment
Description
A Reliable Change Index >1.96 will be obtained fron callous-unemotional, depression and PTSD scales of each participant. This index indicates a significant clinical improvement.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For maltreated children group (MC) Ages between 7 to 12 years old History of trauma or abuse Symptoms of Post traumatic stress disorder Symptoms of anxiety For healthy control (HC) Ages between 7 to 12 years old No history of trauma or abuse Absence or low symptoms of Post Traumatic Stress Disorder Absence or low symptoms of anxiety Exclusion Criteria: • Any neurodevelopmental, medical condition or risk factor other than maltreatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feggy Ostrosky, Ph.D.
Organizational Affiliation
Facultad de Psicología UNAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Psicología UNAM
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share any data.
Citations:
PubMed Identifier
23768722
Citation
Admon R, Milad MR, Hendler T. A causal model of post-traumatic stress disorder: disentangling predisposed from acquired neural abnormalities. Trends Cogn Sci. 2013 Jul;17(7):337-47. doi: 10.1016/j.tics.2013.05.005. Epub 2013 Jun 12.
Results Reference
background
PubMed Identifier
28924828
Citation
Akiki TJ, Averill CL, Abdallah CG. A Network-Based Neurobiological Model of PTSD: Evidence From Structural and Functional Neuroimaging Studies. Curr Psychiatry Rep. 2017 Sep 19;19(11):81. doi: 10.1007/s11920-017-0840-4.
Results Reference
result
PubMed Identifier
25470696
Citation
Blair RJ, Leibenluft E, Pine DS. Conduct disorder and callous-unemotional traits in youth. N Engl J Med. 2014 Dec 4;371(23):2207-16. doi: 10.1056/NEJMra1315612.
Results Reference
result
Citation
Blair, R. J. R., Mitchell, D. G. V., Peschardt, K. S., Colledge, E., Leonard, R. A., Shine, J. H., Murray, L. K., & Perrett, D. I. (2004). Reduced sensitivity to others' fearful expressions in psychopathic individuals. Personality and Individual Differences, 37, 1111-1122. https://doi.org/10.1016/j.paid.2003.10.008
Results Reference
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Citation
Bustos, P., Rincón, P., & Aedo, J. (2009). Validación Preliminar de la Escala Infantil de Síntomas del Trastorno de Estrés Postraumático (Child PTSD Symptom Scale, CPSS) en Niños/as y Adolescentes Víctimas de Violencia Sexual. Psykhe (Santiago), 18(2). https://doi.org/10.4067/S0718-22282009000200008
Results Reference
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PubMed Identifier
20830695
Citation
Deblinger E, Mannarino AP, Cohen JA, Runyon MK, Steer RA. Trauma-focused cognitive behavioral therapy for children: impact of the trauma narrative and treatment length. Depress Anxiety. 2011 Jan;28(1):67-75. doi: 10.1002/da.20744. Epub 2010 Sep 9.
Results Reference
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Citation
Decety, J. (2015). The neural pathways, development and functions of empathy. Current Opinion in Behavioral Sciences, 3, 1-6. https://doi.org/10.1016/j.cobeha.2014.12.001
Results Reference
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PubMed Identifier
27616728
Citation
Kimonis ER, Goulter N, Hawes DJ, Wilbur RR, Groer MW. Neuroendocrine factors distinguish juvenile psychopathy variants. Dev Psychobiol. 2017 Mar;59(2):161-173. doi: 10.1002/dev.21473. Epub 2016 Sep 12.
Results Reference
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PubMed Identifier
27015723
Citation
Patriat R, Birn RM, Keding TJ, Herringa RJ. Default-Mode Network Abnormalities in Pediatric Posttraumatic Stress Disorder. J Am Acad Child Adolesc Psychiatry. 2016 Apr;55(4):319-27. doi: 10.1016/j.jaac.2016.01.010. Epub 2016 Feb 4.
Results Reference
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PubMed Identifier
19880931
Citation
Viding E, Fontaine NM, Oliver BR, Plomin R. Negative parental discipline, conduct problems and callous-unemotional traits: monozygotic twin differences study. Br J Psychiatry. 2009 Nov;195(5):414-9. doi: 10.1192/bjp.bp.108.061192.
Results Reference
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PubMed Identifier
30357832
Citation
Weems CF, Russell JD, Neill EL, McCurdy BH. Annual Research Review: Pediatric posttraumatic stress disorder from a neurodevelopmental network perspective. J Child Psychol Psychiatry. 2019 Apr;60(4):395-408. doi: 10.1111/jcpp.12996. Epub 2018 Oct 25.
Results Reference
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Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data

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