Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed With Attention Deficit Hyperactivity Disorder at Alexandria University Hospitals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Alexandria University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Impulsive aggression severity
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
- Interpersonal effectiveness skills module over 7 weeks.
- Distress tolerance skills module over 8 weeks.
- Walking the middle path skills module over 3 weeks.
Intervention: Dialectical behavioral therapy skills for the intervention experimental group A (Behavioral)
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.
Intervention: psychoeducation or Atomoxetine or stimulants according to ADHD severity (Drug)
Outcomes
Primary Outcomes
Impulsive aggression severity
Time Frame: 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
Time Frame: Change from Baseline 12 month
quantitative CRP
Biomarkers of aggression 2
Time Frame: Change from Baseline 12 month
interleukin 6
Biomarkers of aggression 3
Time Frame: Change from Baseline 12 month
Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique
Secondary Outcomes
- Executive dysfunctions severity(Change from Baseline 12 month)
- ADHD symptom severity(Change from Baseline 12 month)
Investigators
Aya Maged
Doctor
Alexandria University