Dialectical Behavioral Therapy Skills for Impulsive Aggression

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05351944

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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 at least 10 month and testing pre and posttreatment biomarkers of aggression.

Condition or Disease	Intervention/Treatment	Phase
Impulsive Aggression ADHD Executive Dysfunction	Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control clinical trialRandomized control clinical trial

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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 to be repeated 3 times over the whole course of therapy i.e., 9 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

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 to be repeated 3 times over the whole course of therapy i.e., 9 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Executive dysfunctions severity [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
ADHD symptom severity [Change from Baseline 12 month]
using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.