Dialectical Behavioral Therapy Skills for Impulsive Aggression

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05351944
• Other study ID #: 850486055
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 7, 2023
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Aggression
• Executive Dysfunction
• Impulsive Aggression
• Impulsive Behavior

Intervention

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.

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

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Biomarkers of aggression 1	quantitative CRP	Change from Baseline 12 month
Primary	Biomarkers of aggression 2	interleukin 6	Change from Baseline 12 month
Primary	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	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
Secondary	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