Dialectical Behavioral Therapy Skills for Impulsive Aggression

NCT05351944 | Completed DMC

• 1 other identifier: 850486055
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impulsive Aggression; ADHD; Executive Dysfunction

Keywords

DBT; aggression; ADHD; biomarkers; executive functions

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Executive dysfunctions severity

  Change from Baseline 12 month

• ADHD symptom severity

  Change from Baseline 12 month

Study Arms (2)

The intervention group (group A) DBT skills

EXPERIMENTAL

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: 1. Emotion regulation skills module over 8 weeks. 2. Mindfulness skills module over 3 weeks 3. Interpersonal effectiveness skills module over 7 weeks. 4. Distress tolerance skills module over 8 weeks. 5. Walking the middle path skills module over 3 weeks.

Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A

the control group (group B)

ACTIVE COMPARATOR

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

Interventions

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.

The intervention group (group A) DBT skills

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

the control group (group B)

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, 0000, Egypt

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Aggression

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• aya maged, master

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomized control clinical trial

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 28, 2022
• Study Start: May 7, 2023
• Primary Completion: January 21, 2024
• Study Completion: May 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)