Attention Deficit Hyperactivity DisorderNCT03175185
Psychiatric Assessment Of Parents Of Children With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
Trial summary
The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The people participating in this study will be 100 parents of 50 children who were diagnosed with ADHD and 100 parents of 50 children who are ADHD free as a control group recruited from outpatient clinic of Assiut University hospital.
Who may be able to join
- Parents of children diagnosed with ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V).
- Children are between 4 and 16 years of age for both sexes.
- Children with normal IQ > 70%.
- Parents are able to give informed consent and able to complete the research assessments.
Who cannot join
- Parents having chronic debilitating diseases e.g. chronic liver cirrhosis.
- Parents were participating in other clinical research.
- Refusal to participate.
About this study
Official title: Psychiatric Assessment Of Parents Of Children With Attention Deficit Hyperactivity Disorder
The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . These problems may be a precipitating factor to cause ADHD in their child or have a genetic predisposition to be passed to their children. On the other hand these psychological problems may be caused by the difficulties they encounter in raising their ADHD child. The exact relation needs more researches and to be more investigated.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents of children with ADHD | 100 parents of 50 children who were diagnosed with ADHD and | |
| Parent of children without ADHD | 100 parents of 50 children who are ADHD free as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Assessment of the parents
Detection of personality disorders, anxiety and depressive symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Osman Mohammed Elnady Ellisy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175185
- Sponsor's protocol ID
- 17100221
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Assessment Of Parents Of Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03175185
- Acronym / sponsor ID
- 17100221
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . These problems may be a precipitating factor to cause ADHD in their child or have a genetic predisposition to be passed to their children. On the other hand these psychological problems may be caused by the difficulties they encounter in raising their ADHD child. The exact relation needs more researches and to be more investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of children with ADHD | – | –100 parents of 50 children who were diagnosed with ADHD and |
| Parent of children without ADHD | – | –100 parents of 50 children who are ADHD free as a control group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The people participating in this study will be 100 parents of 50 children who were diagnosed with ADHD and 100 parents of 50 children who are ADHD free as a control group recruited from outpatient clinic of Assiut University hospital.
Key inclusion criteria (4 listed)
- Parents of children diagnosed with ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V).
- Children are between 4 and 16 years of age for both sexes.
- Children with normal IQ > 70%.
- Parents are able to give informed consent and able to complete the research assessments.
Key exclusion criteria (3 listed)
- Parents having chronic debilitating diseases e.g. chronic liver cirrhosis.
- Parents were participating in other clinical research.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychiatric Assessment of the parents
Time frame: 2 years
Detection of personality disorders, anxiety and depressive symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric Assessment of the parents (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.