Can Psychopathy be Prevented? Clinical, Neuroimaging and Genetic Data

November 27, 2023 updated by: Feggy Ostrosky Shejet, Universidad Nacional Autonoma de Mexico

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.

Study Overview

Status

Completed

Conditions

Intervention / 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. 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Facultad de Psicología UNAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maltreated children

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
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.
No Intervention: Healthy Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between brain regions and clinical traits after psychological treatment
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical differences at pre treatment between maltreatment group and healthy control
Time Frame: 1 month
Characteristics of clinical traits before treatment in maltreatment and healthy control group.
1 month
Clinical improvement after treatment
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Feggy Ostrosky, Ph.D., Facultad de Psicología UNAM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1-S-13501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share any data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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