NCT06406335

Brief 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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 6, 2024

Last Update Submit

May 9, 2024

Conditions

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • change in BMI after intervention

    6 months

Study Arms (1)

An intervention study (a quasi-experimental design)

OTHER

a quasi-experimental design pre \&post

Other: Health education program

Interventions

Impact of A Multidimensional Health Education Program on Attention deficit hyperactivity disorder (ADHD)

An intervention study (a quasi-experimental design)

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Ain shams university

Cairo, 1181, Egypt

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • rasha saad Hussein, MD

    Faculty of medicine Ain shams univrsity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Epidemiology

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

February 23, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations