Dialectical Behavioral Therapy Skills for Impulsive Aggression

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ADHD; Executive Dysfunction; Impulsive Aggression
• Intervention / Treatment: Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A; Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 0000
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group (group A) DBT skills; Will attend Dialectical Behavioral Therapy skills group for both the children and their parents, DBT is an evidence based comprehensive cognitive behavioral treatment for complex mental disorders and have been adapted for intractable behavioral disorders involving emotion dysregulation, skills will be provided in group therapy as fixed weekly sessions over 9-month duration for all the children and the parents in group A including: Emotion regulation skills module over 8 weeks.; Mindfulness skills module over 3 weeks; Interpersonal effectiveness skills module over 7 weeks.; Distress tolerance skills module over 8 weeks.; Walking the middle path skills module over 3 weeks.	Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A; 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.
Active Comparator: the control group (group B); Will receive psychoeducation and medications targeting ADHD symptoms (stimulants or atomoxetine according to FDA approved dose per age and weight) according to the international guidelines for management of ADHD according to symptom severity, given that assessment before and after intervention will be done by different medical personnel than those providing the intervention for the two groups.	Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impulsive aggression severity	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.	Change from Baseline at 12 month
Biomarkers of aggression 1	quantitative CRP	Change from Baseline 12 month
Biomarkers of aggression 2	interleukin 6	Change from Baseline 12 month
Biomarkers of aggression 3	Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique	Change from Baseline 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive dysfunctions severity	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	Change from Baseline 12 month
ADHD symptom severity	using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity	Change from Baseline 12 month

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: aya maged, master, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; ADHD; aggression; DBT; executive functions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Impulsive Behavior; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 850486055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No