ADHDADHDNCT06406335
Impact of A Multidimensional Health Education Program on Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Health education program in people with ADHD, run by Ain Shams University at 1 site in Egypt.
Trial summary
To measure the impact of a multidimensional health education program on patients' adherence to the healthy life style and behavioral therapy , and to correlate it with severity of ADHD symptoms Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Health education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2024to Aug 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To measure the impact of a multidimensional health education program on patients' adherence to the healthy life style and behavioral therapy , and to correlate it with severity of ADHD symptoms
Read the 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 .
- Conditions
- ADHD
- Being tested
- Health education program
- Keywords
- 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.
Health education programOther
Impact of A Multidimensional Health Education Program on Attention deficit hyperactivity disorder (ADHD)
| Study group | Role | What they receive |
|---|---|---|
| An intervention study (a quasi-experimental design) | Other | a quasi-experimental design pre \&post Receives: Other: Health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Conners' Parent Rating Scale-Revised, Long Version (CPRS-R-L)
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)
Measured: 6 months
Secondary outcomes (1)
change in BMI after intervention
change in the mean of BMI after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start23 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To measure the impact of a multidimensional health education program on patients' adherence to the healthy life style and behavioral therapy , and to correlate it with severity of ADHD symptoms.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Saad, Ain Shams University
- Investigators
- rasha saad Hussein, MD, Principal investigator, Faculty of medicine Ain shams univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406335
- Sponsor's protocol ID
- Health Education Program ADHD
- Acronym
- ADHD
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- 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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of A Multidimensional Health Education Program on Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06406335
- Acronym / sponsor ID
- ADHD / Health Education Program ADHD
- Conditions
- ADHD
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 May 2024 (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.
To measure the impact of a multidimensional health education program on patients' adherence to the healthy life style and behavioral therapy , and to correlate it with severity of ADHD symptoms
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To measure the impact of a multidimensional health education program on patients' adherence to the healthy life style and behavioral therapy , and to correlate it with severity of ADHD symptoms.
| Arm | Type | Receives |
|---|---|---|
| An intervention study (a quasi-experimental design) | Other | Other: Health education programa quasi-experimental design pre \&post |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Health education programImpact of A Multidimensional Health Education Program on Attention deficit hyperactivity disorder (ADHD) | Other | An intervention study (a quasi-experimental design) |
Primary outcome
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)
1 secondary outcome
change in BMI after intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
rasha saad Hussein, MD principal investigator
Faculty of medicine Ain shams univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education program in people with ADHD, run by Ain Shams 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 1 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 13 May 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?
Results are not available in the source record.
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?
change in Conners' Parent Rating Scale-Revised, Long Version (CPRS-R-L) (time frame: 6 months). 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 13 May 2024.