AMindADHDNCT06131190
Effect Mindfulness Training on Attention, Hyperactivity and Emotion Regulation Among Children With ADHD:
A study testing mindfulness training in people with A, run by Alexandria University at 1 site in Egypt.
Trial summary
Mindfulness training is a promising form of training for children with ADHD, as it focuses on attention and has gained empirical support as a complementary or alternative intervention. It involves increasing awareness and nonjudgmental observation of present-moment experiences while reducing automatic responding Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- A
- What is being tested?
- mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Mar 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age from 10-18 years old
- diagnosed with ADHD
Who cannot join
- age less than 10
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Husien
Alexandria, Please Select A Country, 21913
eman H taha, +202026609088, mohamed-hussein@alexu.edu.com
About this study
Official title: Effect Mindfulness Based Training on Attention, Hyperactivity and Emotion Regulation Among Children With ADHD: A Randomized Controlled Trails
Mindfulness training is a promising form of training for children with ADHD, as it focuses on attention and has gained empirical support as a complementary or alternative intervention. It involves increasing awareness and nonjudgmental observation of present-moment experiences while reducing automatic responding
Read the detailed description
training to sustain focus on present-moment experiences and gently shifting attention back to the meditation object when the mind drifts (Bishop, et al., 2004). Mindfulness meditation is a relatively new approach for reducing stress and emotion regulation difficulties among children. While researching the efficacy of mindfulness training in children is a new domain, existing evidence suggests that it has positive effects on psychological well-being, pain management, emotion dysregulation, negative behaviors, and cognitive/executive functions and attention (Evans et al., 2018; Zhang, Díaz-Román, \& Cortese,2018).
Nurses have an important role in caring for children with ADHD, particularly in the context of mindfulness-based interventions. They can provide education and support to both parents and children regarding the benefits of mindfulness practice and can help implement mindfulness programs in clinical and community settings.
- Conditions
- A
- Being tested
- mindfulness training
- Keywords
- Mindfulness, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness trainingBehavioural
it focuses on attention and has gained empirical support as a complementary or alternative intervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | ADHD child who exposed to mindfulness training Receives: Behavioral: mindfulness training |
| control group | No intervention | ADHD child take only pharmocological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
study group
ADHD child who exposed to mindfulness training exhibit higher attention and less hyperactivity than whom not exposed (Vanderbit Assessment scale)
Measured: three months
Secondary outcomes (1)
study group
ADHD child who exposed to mindfulness training exhibit higher emotion regulationthan whom not exposed (emotional regulation inventory)
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Oct 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effect Mindfulness Based Training on Attention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131190
- Sponsor's protocol ID
- 85-b
- Acronym
- MindADHD
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elzohairy NW, Elzlbany GAM, Khamis BI, El-Monshed AH, Atta MHR. Mindfulness-based training effect on attention, impulsivity, and emotional regulation among children with ADHD: The role of family engagement in randomized controlled trials. Arch Psychiatr Nurs. 2024 Dec;53:204-214. doi: 10.1016/j.apnu.2024.10.001. Epub 2024 Oct 9.
PubMed 39615936
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Mindfulness Based Training on Attention, Hyperactivity and Emotion Regulation Among Children With ADHD: A Randomized Controlled Trails
- ClinicalTrials.gov ID
- NCT06131190
- Acronym / sponsor ID
- MindADHD / 85-b
- Conditions
- A
- Keywords
- Mindfulness, ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
Mindfulness training is a promising form of training for children with ADHD, as it focuses on attention and has gained empirical support as a complementary or alternative intervention. It involves increasing awareness and nonjudgmental observation of present-moment experiences while reducing automatic responding
Detailed description
training to sustain focus on present-moment experiences and gently shifting attention back to the meditation object when the mind drifts (Bishop, et al., 2004). Mindfulness meditation is a relatively new approach for reducing stress and emotion regulation difficulties among children. While researching the efficacy of mindfulness training in children is a new domain, existing evidence suggests that it has positive effects on psychological well-being, pain management, emotion dysregulation, negative behaviors, and cognitive/executive functions and attention (Evans et al., 2018; Zhang, Díaz-Román, \& Cortese,2018).
Nurses have an important role in caring for children with ADHD, particularly in the context of mindfulness-based interventions. They can provide education and support to both parents and children regarding the benefits of mindfulness practice and can help implement mindfulness programs in clinical and community settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Effect Mindfulness Based Training on Attention
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: mindfulness trainingADHD child who exposed to mindfulness training |
| control group | No intervention | –ADHD child take only pharmocological intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age from 10-18 years old
- diagnosed with ADHD
Key exclusion criteria (1 listed)
- age less than 10
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 |
|---|---|---|
| mindfulness trainingit focuses on attention and has gained empirical support as a complementary or alternative intervention | Behavioural | study group |
Primary outcome
study group
Time frame: three months
ADHD child who exposed to mindfulness training exhibit higher attention and less hyperactivity than whom not exposed (Vanderbit Assessment scale)
1 secondary outcome
study group
Time frame: 3 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39615936Elzohairy NW, Elzlbany GAM, Khamis BI, El-Monshed AH, Atta MHR. Mindfulness-based training effect on attention, impulsivity, and emotional regulation among children with ADHD: The role of family engagement in randomized controlled trials. Arch Psychiatr Nurs. 2024 Dec;53:204-214. doi: 10.1016/j.apnu.2024.10.001. Epub 2024 Oct 9.
Related trials for A
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness training in people with A, 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed H atta (+202026609088, mohamed-hussein@alexu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study group (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06131190, which also lists 1 linked publication.
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 14 Nov 2023.