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Dialectical Behavioral Therapy Skills for Impulsive Aggression

A

Alexandria University

Status

Completed

Conditions

Impulsive Aggression
ADHD
Executive Dysfunction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05351944
850486055

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Male

Ages

6 to 13 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

The intervention group (group A) DBT skills
Experimental group
Description:
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.
Treatment:
Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A
the control group (group B)
Active Comparator group
Description:
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.
Treatment:
Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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