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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06406335
Other study ID # Health Education Program ADHD
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 23, 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 .


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity

Intervention

Other:
Health education program
Impact of A Multidimensional Health Education Program on Attention deficit hyperactivity disorder (ADHD)

Locations

Country Name City State
Egypt faculty of medicine Ain shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 6 months
Secondary change in BMI after intervention change in the mean of BMI after intervention 6 months
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