Back to resultsDialectical Behavioral Therapy Skills for Impulsive Aggression
Primary Purpose
Impulsive Aggression, ADHD, Executive Dysfunction
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dialectical behavioral therapy skills for the intervention experimental group A
psychoeducation or Atomoxetine or stimulants according to ADHD severity
Sponsored by
About this trial
This is an interventional treatment trial for Impulsive Aggression focused on measuring DBT, aggression, ADHD, biomarkers, executive functions
Eligibility Criteria
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.
Sites / Locations
- Alexandria university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The intervention group (group A) DBT skills
the control group (group B)
Arm 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: 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.
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.
Outcomes
Primary Outcome Measures
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.
Biomarkers of aggression 1
quantitative CRP
Biomarkers of aggression 2
interleukin 6
Biomarkers of aggression 3
Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique
Secondary Outcome Measures
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
ADHD symptom severity
using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05351944
Brief Title
Dialectical Behavioral Therapy Skills for Impulsive Aggression
Official Title
Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed With Attention Deficit Hyperactivity Disorder at Alexandria University Hospitals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Aggression, ADHD, Executive Dysfunction
Keywords
DBT, aggression, ADHD, biomarkers, executive functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The intervention group (group A) DBT skills
Arm Type
Experimental
Arm 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:
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.
Arm Title
the control group (group B)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavioral therapy skills for the intervention experimental group A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
psychoeducation or Atomoxetine or stimulants according to ADHD severity
Intervention Description
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
Primary Outcome Measure Information:
Title
Impulsive aggression severity
Description
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
Title
Biomarkers of aggression 1
Description
quantitative CRP
Time Frame
Change from Baseline 12 month
Title
Biomarkers of aggression 2
Description
interleukin 6
Time Frame
Change from Baseline 12 month
Title
Biomarkers of aggression 3
Description
Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique
Time Frame
Change from Baseline 12 month
Secondary Outcome Measure Information:
Title
Executive dysfunctions severity
Description
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
Title
ADHD symptom severity
Description
using Conner's parent rating scale for ADHD pre and post treatment to assess change in severity
Time Frame
Change from Baseline 12 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aya maged, master
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria university
City
Alexandria
ZIP/Postal Code
0000
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Dialectical Behavioral Therapy Skills for Impulsive Aggression
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