Attention-deficit/Hyperactivity DisorderNCT02329236
Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay
An observational study of Attention-deficit/Hyperactivity Disorder and Constitutional Growth Delay, run by Meir Medical Center.
Trial summary
The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder, Constitutional Growth Delay
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with short stature due to constitutional growth delay or familial short stature followed at the endocrine unit.
Who may be able to join
- undergo evaluation and follow-up due to short stature caused by either CGD or Familial short stature
Who cannot join
- Children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes
About this study
The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.
Read the detailed description
Filling out the study questionnaire by ADHD diagnosed and suspected children (have a positive DBDRS (Disruptive Behavior Disorders Rating Scale Questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. The study questionnaire will be filled by child's guardian.
The study and the DBDRS questionnaires will be filled only after obtaining an informed consent.
The required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records.
The data on patients will be processed anonymously.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Puberty, Delayed
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 |
|---|---|---|
| children with constitutional growth delay | Not described | |
| children with Familial short stature | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of ADHD among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature
Measured: single point in time during the visit at the endocrine clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Nitsan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329236
- Sponsor's protocol ID
- meir medical center
- Status last verified
- Dec 2014
- First submitted
- 26 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay
- ClinicalTrials.gov ID
- NCT02329236
- Acronym / sponsor ID
- meir medical center
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- 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 the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.
Detailed description
Filling out the study questionnaire by ADHD diagnosed and suspected children (have a positive DBDRS (Disruptive Behavior Disorders Rating Scale Questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. The study questionnaire will be filled by child's guardian.
The study and the DBDRS questionnaires will be filled only after obtaining an informed consent.
The required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records.
The data on patients will be processed anonymously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with constitutional growth delay | – | – |
| children with Familial short stature | – | – |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with short stature due to constitutional growth delay or familial short stature followed at the endocrine unit.
Key inclusion criteria (1 listed)
- undergo evaluation and follow-up due to short stature caused by either CGD or Familial short stature
Key exclusion criteria (1 listed)
- Children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes
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
incidence of ADHD among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature
Time frame: single point in time during the visit at the endocrine clinic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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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 and Constitutional Growth Delay, run by Meir Medical Center.
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 1 inclusion and 1 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 31 Dec 2014. 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?
incidence of ADHD among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature (time frame: single point in time during the visit at the endocrine clinic). 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 31 Dec 2014.