An interventional study of Dialectical behavioral therapy skills for the intervention experimental group A and psychoeducation or Atomoxetine or stimulants according to ADHD severity in Impulsive Aggression, ADHD and Executive Dysfunction, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to male participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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
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
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 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
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.
Time frame: Change from Baseline at 12 month
Biomarkers of aggression 1
quantitative CRP
Time frame: Change from Baseline 12 month
Biomarkers of aggression 2
interleukin 6
Time frame: 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
Time frame: Change from Baseline 12 month
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
Time frame: 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
Time frame: Change from Baseline 12 month
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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