Skip to main content
OpenTrials
Completed

NCT Number: NCT05351944

Dialectical Behavioral Therapy Skills for Impulsive Aggression

This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Impulsive Aggression ADHD Aberrant Motor Behavior in Dementia Aggression Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Executive Dysfunction Mental Disorders Neurodevelopmental Disorders Social Behavior

Age range

6 year–13 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university

Alexandria, 0000, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from 6 to 13-year-old.
  • Patients diagnosed with ADHD and presented with impulsive aggression.
  • Commitment to therapy from the child and the parent.
  • Written consent of all the children parents.
  • Male gender.
  • Drug naïve or stopped medications for at least one month.

Exclusion criteria

  • Patients younger than 6 years of age as it's the starting age for DBT-C.
  • Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent.
  • Patients diagnosed with drug abuse.
  • Patients with severe sensory impairment or intellectual disability.
  • Drug induced aggression as levetiracetam, topiramate and benzodiazepines.
  • Patients diagnosed with Autism spectrum disorder or psychotic disorders.

Treatment and study plan

Dialectical behavioral therapy skills for the intervention experimental group A

Behavioral

Our hypothesis is that impulsive aggression as evidenced by inflammatory biomarkers might improve by targeting executive dysfunctions with Dialectical Behavioural Therapy skills modules directed to the children and their parents in the form of response inhibition dysfunctions with Dialectical Behavioural Therapy mindfulness and distress tolerance skills modules, emotion regulation executive dysfunctions with Dialectical Behavioural Therapy emotion regulation skills module and socioenvironmental factors with interpersonal effectiveness and walking the middle path Dialectical behavioural therapy skills modules.

psychoeducation or Atomoxetine or stimulants according to ADHD severity

Drug

the control group (group B) will receive psychoeducation and medications targeting ADHD symptoms (Atomoxetine or stimulants according to FDA approved dose according to age and weight ) according to the international guidelines for management of ADHD according to symptom severity

Primary outcomes

  1. Impulsive aggression severity

    Time frame: Change from Baseline at 12 month

    Using Modified overt aggression scale ,This scale rates the patient's aggressive behavior regarding four types of aggression (verbal, against objects, against self, against others) to give a total MOAS score about the patient's aggressive behavior. Each type of aggression had a rating of 0 when aggression was absent and four levels of severity. Weighted scores are then added together to yield the total score.

  2. Biomarkers of aggression 1

    Time frame: Change from Baseline 12 month

    quantitative CRP

  3. Biomarkers of aggression 2

    Time frame: Change from Baseline 12 month

    interleukin 6

  4. Biomarkers of aggression 3

    Time frame: Change from Baseline 12 month

    Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique

Secondary outcomes

  1. Executive dysfunctions severity

    Time frame: Change from Baseline 12 month

    using Barkley Deficits In Executive Functioning Scale - Children and Adolescents ,The manuals indicate that results from the scale can be interpreted using normative comparisons (percentile scores based on sex and age group

  2. ADHD symptom severity

    Time frame: Change from Baseline 12 month

    using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed with Attention Deficit Hyperactivity Disorder At Alexandria University Hospitals

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.