Dialectical Behavioral Therapy Skills for Impulsive Aggression

Not Applicable

Active, not recruiting

• Conditions: ADHD; Executive Dysfunction; Impulsive Aggression
• Interventions: Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A; Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity

• Registration Number: NCT05351944
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-23
• Study First Posted: 2022-04-28
• Study Start: 2023-05-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group (group A) DBT skills	Dialectical behavioral therapy skills for the intervention experimental group A	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.
the control group (group B)	psychoeducation or Atomoxetine or stimulants according to ADHD severity	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt