Impulsive AggressionNCT05351944
Dialectical Behavioral Therapy Skills for Impulsive Aggression
A study testing Dialectical behavioral therapy skills for the intervention experimental group A and psychoeducation or Atomoxetine or stimulants according to ADHD severity in people with Impulsive Aggression and ADHD, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 years, men only
- Conditions the study is for
- Impulsive Aggression, ADHD, Executive Dysfunction
- What is being tested?
- Dialectical behavioral therapy skills for the intervention experimental group A and psychoeducation or Atomoxetine or stimulants according to ADHD severity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2023to 18 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed with Attention Deficit Hyperactivity Disorder At Alexandria University Hospitals
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.
- Conditions
- Impulsive Aggression, ADHD, Executive Dysfunction
- Being tested
- Dialectical behavioral therapy skills for the intervention experimental group A, psychoeducation or Atomoxetine or stimulants according to ADHD severity
- Keywords
- DBT, aggression, ADHD, biomarkers, executive functions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioral therapy skills for the intervention experimental group ABehavioural
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.
psychoeducation or Atomoxetine or stimulants according to ADHD severityDrug
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
| Study group | Role | What they receive |
|---|---|---|
| The intervention group (group A) DBT skills | Experimental | 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. Receives: Behavioral: Dialectical behavioral therapy skills for the intervention experimental group A |
| the control group (group B) | Active comparator | 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. Receives: Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 12 month
Biomarkers of aggression 1
quantitative CRP
Measured: Change from Baseline 12 month
Biomarkers of aggression 2
interleukin 6
Measured: 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
Measured: Change from Baseline 12 month
Secondary outcomes (2)
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
Measured: 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
Measured: Change from Baseline 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start7 May 2023
- Primary completion21 Jan 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Maged, Alexandria University
- Investigators
- aya maged, master, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351944
- Sponsor's protocol ID
- 850486055
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed with Attention Deficit Hyperactivity Disorder At Alexandria University Hospitals
- ClinicalTrials.gov ID
- NCT05351944
- Acronym / sponsor ID
- 850486055
- Conditions
- Impulsive Aggression, ADHD, Executive Dysfunction
- Keywords
- DBT, aggression, ADHD, biomarkers, executive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| The intervention group (group A) DBT skills | Experimental | Behavioral: Dialectical behavioral therapy skills for the intervention experimental group AWill 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) | Active comparator | Drug: psychoeducation or Atomoxetine or stimulants according to ADHD severityWill 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical behavioral therapy skills for the intervention experimental group AOur 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. | Behavioural | The intervention group (group A) DBT skills |
| psychoeducation or Atomoxetine or stimulants according to ADHD severitythe 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 | Drug | the control group (group B) |
Primary outcome
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
2 secondary outcomes
Executive dysfunctions severity
Time frame: Change from Baseline 12 month
ADHD symptom severity
Time frame: Change from Baseline 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aya maged, master principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavioral therapy skills for the intervention experimental group A and psychoeducation or Atomoxetine or stimulants according to ADHD severity in people with Impulsive Aggression and ADHD, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impulsive aggression severity (time frame: Change from Baseline at 12 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.