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Psychopathic Personality TraitNCT06028620

Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data

A study testing Trauma Focused-Cognitive Behavior Therapy in people with Psychopathic Personality Trait, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Psychopathic Personality Trait
What is being tested?
Trauma Focused-Cognitive Behavior Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteMexico
Study dates
1 Feb 2020to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Facultad de Psicología UNAM

    Mexico City

Other trials in Mexico

About this study

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.

Read the 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. The Spence Children's Anxiety Scale-SCAS standardized on a sample of Mexican children, the Child PTSD Symptom Scale-CPSS Spanish version, and the Inventory of Callous Unemotional Traits-ICU Spanish version.

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.

Being tested
Trauma Focused-Cognitive Behavior Therapy
Keywords
children maltreatment, neurodevelopmental psychopathy, post-traumatic stress disorder, neuroimaging, brain reorganization
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma Focused-Cognitive Behavior TherapyBehavioural

    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.

Study groups in NCT06028620
Study groupRoleWhat they receive
Maltreated childrenExperimentalThe 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.
Receives: Behavioral: Trauma Focused-Cognitive Behavior Therapy
Healthy Control groupNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (2)
  1. Clinical differences at pre treatment between maltreatment group and healthy control

    Characteristics of clinical traits before treatment in maltreatment and healthy control group.

    Measured: 1 month

  2. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start1 Feb 2020
  3. Primary completion1 Nov 2021
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028620
Sponsor's protocol ID
A1-S-13501
Status last verified
Nov 2023
First submitted
23 Aug 2023
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share any data.

Publications

  • 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.

    PubMed 23768722
  • 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.

    PubMed 28924828
  • 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.

    PubMed 25470696
  • 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

  • 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

  • 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.

    PubMed 20830695
  • 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

  • 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.

    PubMed 27616728
  • 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.

    PubMed 27015723
  • 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.

    PubMed 19880931
  • 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.

    PubMed 30357832

Questions about this trial

What is this clinical trial studying?

A study testing Trauma Focused-Cognitive Behavior Therapy in people with Psychopathic Personality Trait, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlations between brain regions and clinical traits after psychological treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028620, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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