Assessment of Depression, Anxiety and ADHD Among Children and Adolescents With Congenital Heart DiseasePsychiatricyNCT06836076
Assessment of Depression, Anxiety and ADHD Among Children and Adolescents With Congenital Heart Disease.
An observational study of Assessment of Depression, Anxiety and ADHD Among Children and Adolescents With Congenital Heart Disease, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Assessment of Depression, Anxiety and ADHD Among Children and Adolescents With Congenital Heart Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
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 18 years
- All sexes
- Child, Adult
Study population: depression, anxiety and ADHD among children and adolescents with congenital heart disease.
Who may be able to join
- childern age from 6 to less than 18
- childern with simple and complex CHD
- in patient and out patient childern
- preoperative and postoperative patient
Who cannot join
- patient indicated for icu
- patient with critical arrythmias
- caregiver refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Keywords
- congenital heart disease, Assessment of depression, anxiety and ADHD
- Medical subject headings
- Anxiety Disorders, Heart Defects, Congenital, Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
• The Child Behaviour Checklist (CBCL/6-18) (arabic version)
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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Assessment of Depression, Anxiety and ADHD Among Children and Adolescents With Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Ashraf Abbdelgawad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836076
- Sponsor's protocol ID
- Psychiatric disorders children
- Acronym
- Psychiatricy
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernaras E, Jaureguizar J, Garaigordobil M. Child and Adolescent Depression: A Review of Theories, Evaluation Instruments, Prevention Programs, and Treatments. Front Psychol. 2019 Mar 20;10:543. doi: 10.3389/fpsyg.2019.00543. eCollection 2019.
PubMed 30949092