NCT06131190

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

November 14, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

November 9, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

MindfulnessADHD

Outcome Measures

Primary Outcomes (1)

  • study group

    ADHD child who exposed to mindfulness training exhibit higher attention and less hyperactivity than whom not exposed (Vanderbit Assessment scale)

    three months

Secondary Outcomes (1)

  • study group

    3 monthes

Study Arms (2)

study group

EXPERIMENTAL

ADHD child who exposed to mindfulness training

Behavioral: mindfulness training

control group

NO INTERVENTION

ADHD child take only pharmocological intervention

Interventions

it focuses on attention and has gained empirical support as a complementary or alternative intervention

study group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age from 10-18 years old
  • diagnosed with ADHD

You may not qualify if:

  • age less than 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Husien

Alexandria, Please Select A Country, 21913, Egypt

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Effect Mindfulness Based Training on Attention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

October 1, 2023

Primary Completion

December 30, 2023

Study Completion

March 30, 2024

Last Updated

November 14, 2023

Record last verified: 2023-09

Locations