Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data

NCT06028620 | Completed

• 1 other identifier: A1-S-13501
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychopathic Personality Trait

Keywords

children maltreatment; neurodevelopmental psychopathy; post-traumatic stress disorder; neuroimaging; brain reorganization

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Clinical differences at pre treatment between maltreatment group and healthy control

  1 month

• Clinical improvement after treatment

  6 months

Study Arms (2)

Maltreated children

EXPERIMENTAL

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.

Behavioral: Trauma Focused-Cognitive Behavior Therapy

Healthy Control group

NO INTERVENTION

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.

Interventions

Trauma Focused-Cognitive Behavior Therapy BEHAVIORAL

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.

Maltreated children

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any neurodevelopmental, medical condition or risk factor other than maltreatment.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Facultad de Psicología UNAM

Mexico City, Mexico

Location

Related Publications (11)

• 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.

  PMID: 23768722 BACKGROUND

• 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.

  PMID: 28924828 RESULT

• 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.

  PMID: 25470696 RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 20830695 RESULT

• 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

  RESULT

• 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.

  PMID: 27616728 RESULT

• 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.

  PMID: 27015723 RESULT

• 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.

  PMID: 19880931 RESULT

• 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.

  PMID: 30357832 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Feggy Ostrosky, Ph.D.

  Facultad de Psicología UNAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuropsychology and Psychophisiology Laboratory

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 8, 2023
• Study Start: February 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: June 1, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)