- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406335
Impact of A Multidimensional Health Education Program on Attention Deficit Hyperactivity Disorder (ADHD) (ADHD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder whose etiology is the result of complex interactions between multiple factors, including genetic, biological, and environmental influences. Attention deficit hyperactivity disorder (ADHD) is a condition that affects people's behavior. People with ADHD can seem restless, may have trouble concentrating, and may act on impulse. Symptoms of ADHD tend to be noticed at an early age and may become more noticeable when a child's circumstances change, such as when they start school. Most cases are diagnosed when children are 3 to 7 years old, but sometimes it's diagnosed later in childhood .
A mean worldwide prevalence of attention-deficit hyperactivity disorder (ADHD), or hyperkinetic disorder (HKD), of ~2.2% overall (range, 0.1-8.1%) has been estimated in children and adolescents (aged <18 years) . Regarding the prevalence of ADHD in Arabic countries, results from previous studies showed that it reached 9.4-21.8% in Egypt ,and 11.6% in Saudi Arabia .
Several harmful consequences are associated with ADHD, including deficient academic/work performance, social isolation, aggressive behavior (including delinquency and illegal acts), and even premature death from unnatural causes (such as accidents) Undesirable lifestyle factors could contribute directly to inattention and/or hyperactivity symptoms, numerous mechanisms exist that could mediate such effects, such as secondary effects on energy level, immune function, and epigenetic change.
Study findings showed that children with ADHD were approximately two times as likely to have a healthy lifestyle index that is lower than children without ADHD Multiple studies on alternative interventions for ADHD aim at the prevention of ADHD progression and targeting the underlying triggers (such as stress, poor sleep, overstimulation, technology or dietary plans). On the basis that making adequate lifestyle changes to minimize these triggers could contribute to better control of ADHD symptoms .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 1181
- Faculty of medicine Ain shams university
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients newly diagnosed with mild and moderate ADHD not receiving medications or behavioral therapy, aged 6-9 years, and parents are motivated to participate in the lifestyle modification program.
Exclusion Criteria:
- Children with severe form of ADHD or with comorbid psychiatric disorders rather than disruptive behavior disorders, and children with an intelligence quotient score below 80 were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: An intervention study (a quasi-experimental design)
a quasi-experimental design pre &post
|
Impact of A Multidimensional Health Education Program on Attention deficit hyperactivity disorder (ADHD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Conners' Parent Rating Scale-Revised, Long Version (CPRS-R-L)
Time Frame: 6 months
|
change in mean score Conners' Parent Rating Scale-Revised, Long Version (CPRS-R-L).
the Conners' Parents Rating Scale consists of eighty items that need to be rated from zero to 3 (zero means no, 3 means very frequent.
the Conners' Rating Scales use the T-score standardized measure to assess results.
If a child's T-score is less than 60, that means they don't have ADHD.
If the child has a T-score that's higher than 60, that means they likely have ADHD.
If the score is higher than 70, their ADHD symptoms are severe)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in BMI after intervention
Time Frame: 6 months
|
change in the mean of BMI after intervention
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: rasha saad Hussein, MD, Faculty of medicine Ain shams univrsity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Health Education Program ADHD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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