- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836076
Assessment of Depression, Anxiety and ADHD Among Children and Adolescents with Congenital Heart Disease. (Psychiatricy)
February 15, 2025 updated by: Samia Ashraf Abbdelgawad, Assiut University
Congenital heart disease (CHD) is the most common birth defect, affecting ∼1% of all live births.The spectrum of CHD is wide, ranging from simple (not requiring immediate or possibly any surgical intervention) to severe or complex (typically defined as CHD requiring surgical intervention within the first month to year of life).
Study Overview
Status
Not yet recruiting
Detailed Description
Although overall mortality has improved, most notably in those with complex CHD, many surgical and medical procedures are palliative, and these patients often require multiple interventions throughout their lifetime.
Increased CHD survival is now resulting in a continually growing population of adolescents and adults with CHD; this has drawn more attention to the noncardiac comorbidities, including overall mental health, of patients with CHD.There are multiple psychological theories that can potentially explain some of the mental health disorders seen in patients with CHD, such as stressful life events and sociocultural impacts (eg, parenting style).Cognitive models, including learned helplessness and negative information processing, may also contribute to the mental health of children with CHD, who often spend significant amounts of time in the hospital and undergo cardiac procedures and surgeries.
The presence of underlying genetic syndromes, parental mental health disorders, cardiopulmonary bypass, prematurity, and prolonged hospitalizations are factors that increase the risk of neurodevelopmental disabilities (NDDs) and likely contribute to anxiety, depression, and attention-deficit/hyperactivity disorder (ADHD) in adolescents and adults with complex CHD.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samia Ashraf adelgawad
- Phone Number: 201009650059
- Email: samiaashref4@gmail.com
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
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
depression, anxiety and ADHD among children and adolescents with congenital heart disease.
Description
Inclusion Criteria:
- childern age from 6 to less than 18
- childern with simple and complex CHD
- in patient and out patient childern
- preoperative and postoperative patient
Exclusion Criteria:
- patient indicated for icu
- patient with critical arrythmias
- caregiver refuse to participate in the study
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• The Child Behaviour Checklist (CBCL/6-18) (arabic version)
Time Frame: 1 years
|
is a 113-item parent report measure designed to assess behavioural and emotional problems in children and young people aged 6-18 years.
This most recent version of the original measure includes items and subscales aimed at assessing symptoms of anxiety, depression, somatic complaints (that is, physiological symptoms frequently associated with internalising behaviours like anxiety and depression), social problems, thought problems, attention problems, rule-breaking behaviour and aggressive behaviour.
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
February 1, 2025
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
February 15, 2025
First Submitted That Met QC Criteria
February 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 15, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Psychiatric disorders children
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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