Dialectical Behavioral Therapy Skills for Impulsive Aggression

Study Overview
=================
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.

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

Conditions
-----------------
Impulsive Aggression, ADHD, Executive Dysfunction

Intervention / Treatment
-----------------
* Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A
* Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group (group A) DBT skills<br>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<br>* 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.<br>|
| Active Comparator: the control group (group B)<br>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<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aggression, DBT, ADHD, biomarkers, executive functions