Impact of A Multidimensional Health Education Program on Attention Deficit Hyperactivity Disorder (ADHD) (ADHD)

May 9, 2024 updated by: Rasha Saad, Ain Shams University
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

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 1181
        • Faculty of medicine Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: rasha saad Hussein, MD, Faculty of medicine Ain shams univrsity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Health Education Program ADHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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