Adolescent BehaviorNCT03564223
The Great Ormond Street Hospital Top Child and Adolescent Health Study
An observational study of Adolescent Behavior and Child Behavior, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
The Great Ormond Street Hospital (GOSH) Top child and adolescent health problems study aims to identify the top health concerns that parents/guardians and paediatricians in a tertiary hospital have for young people in England. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Child Behavior, Parents
- How many people
- 425 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2018to 28 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents/guardians attending GOSH OPD (nA) * Target Population = Yearly OPD attendance = 308,457 * Confidence Level is 95% * Margin of error = 5% * Target Sample Size = 384, approximately 400 * Sampling will be matched to attendance proportions in the six OPD areas - Cheetah, Manta ray, Rhino, Zebra, Hare and Hippo. Paediatricians (nB) * Target population = 400 Paediatricians at GOSH * Confidence Level is 95% * Margin of error = 5% * Target Sample Size = 197, approximately 200 * There will be no power calculation done. No statistical testing will be conducted
Who may be able to join
- Parents/Guardians attending GOSH NHS Foundation Trust Outpatients
- Paediatricians practicing at GOSH
Who cannot join
- Parents/Guardians and Paediatricians outside the GOSH or NHS England
- Children aged under 18 years old
- Inpatients
- Parents/Guardians who cannot communicate in English and do not have an interpreter
- Participants who have previously responded to the questionnaire
- Outpatient coordinator or Nurse in Charge feels that the potential participant may be vulnerable, or have complex issues.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Institute of Child Health
London, WC1N 1EH
About this study
The Great Ormond Street Hospital (GOSH) Top child and adolescent health problems study aims to identify the top health concerns that parents/guardians and paediatricians in a tertiary hospital have for young people in England. 400 parents or guardians attending GOSH outpatients and 200 Paediatricians working at GOSH will be asked to rank a list of 30 child health concerns and results compared. Analysis will be done by demographics as well.
Read the detailed description
The GOSH top child and adolescent health problems study aims to identify the top health concerns that parents/guardians and paediatricians in a tertiary hospital have for young people in England. The study will be surveying parents/guardians and paediatricians at Great Ormond Street Hospital (GOSH), asking them to review and give their impressions from a list of thirty common child and adolescent health issues. Analysis of responses will provide a list of problems that are most important and determine if respondents feel that the NHS England is adequately addressing these problems.
The project was designed with public partnership. The investigators conducted literature reviews, and adopted with permission, a survey instrument used by the C.S. Mott Children's Hospital National Poll in Michigan, USA. Some parents were asked to list child and adolescent health problems that they deemed most important. A consensus meeting with experts was held, to select the thirty most common and important public health issues for young people in England, from which the study will identify problems with the highest concern. This project and its intended outcomes will span medical, nursing, research and voluntary services that will improve child and adolescent healthcare provision the UK.
The State of Child Health (SoCH) Report 2017 highlights indicators of child health problems across the four nations of the United Kingdom. There are some polls that were conducted in Australia and USA, investigating the top concerns for child health problems and thus providing a framework onto which to find solutions. The Royal Children's Hospital Melbourne through its National Child Health Poll established that that excessive screen time was the greatest parental concern, and that the top ten concerns related to modern lifestyle, mental health and child safety. Similarly, the C.S. Mott Children's Hospital National Poll on children's health selected a national sample of adults to identify health topics that are a "big problem" for children and teenagers. The 2017 report identified bullying/cyberbullying as the greatest concern. However there is no available evidence about studies being conducted in the United Kingdom to find out what parents/guardians and paediatricians report as the top child and adolescent health problems.
The information would be valuable to the health professionals at the point of care, as well as the national healthcare system. This study analyses information from groups on both the supply and demand side of child and adolescent healthcare. Understanding the different perceptions of child and adolescent health problems between healthcare professionals and parents/guardians can lead to improved follow-up care and compliance with advice. Information from this study can be used as a basis for the establishment of a UK national poll that would further investigate public concerns for child health.
- Conditions
- Adolescent Behavior, Child Behavior, Parents
- Keywords
- Adolescent, Parental concerns, Child Health, Paediatrician Concerns
- Medical subject headings
- Adolescent Behavior, Child Behavior
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/Guardians | Parents/Guardians aged over 18, attending Great Ormond Street Hospital Outpatients. Intervention: Administer questionnaire to review and decide on significance of each of 30 child health concerns | |
| Paediatricians | Paediatricians working at Great Ormond Street Hospital NHS Foundation Trust. Intervention: Administer questionnaire to review and decide on significance of each of 30 child health concerns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Top 10 Child Health Concerns
Ranking of Top Child Health Concerns by Parents and Paediatricians, which will obtained by asking both groups to state on a 4-point Likert scale on how they rate the significance of each of 30 child health concerns.
4 categorical ordinal responses from better to worse; Not a problem, small problem, moderate problem and large problem. These rankings will be analysed with weighted values assigned (0, 1, 2, 3). There is an option for I don't know.
This will enable determination of top 10 child health concerns
Measured: 12 Months
Adequacy of NHS perceptions
Parents and Paediatricians are asked to decide if they think the NHS is adequately addressing adolescent and child health issues, on a 5-point Likert scale rating agreement with the statement.
5 categorical ordinal responses from better to worse; Strongly agree, agree, neutral, disagree, strongly disagree. These rankings will be recoded in analysis as 'Disagree' (Strongly disagree, disagree) and 'Do not disagree' (Neutral, agree, strongly agree).
Measured: 12 Months
Determination of Top 3 information sources for parents and paediatricians
Parents and Paediatricians are asked to list their top three information sources, and these will be analysed to determine the three most common sources of information for each group.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start31 Jul 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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 Adolescent BehaviorStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikram Palit, Principal investigator, Great Ormond Street Hospital Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564223
- Sponsor's protocol ID
- 18DD02
- Other IDs
- IRAS Project ID: 238932
- Status last verified
- Apr 2024
- First submitted
- 11 Jun 2018
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan made to share IPD. This project is part of an educational project for the fulfillment of an MSc. Paediatrics and Child Health at University College London.
Publications
Garbutt JM, Leege E, Sterkel R, Gentry S, Wallendorf M, Strunk RC. What are parents worried about? Health problems and health concerns for children. Clin Pediatr (Phila). 2012 Sep;51(9):840-7. doi: 10.1177/0009922812455093. Epub 2012 Jul 26.
PubMed 22843294
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Great Ormond Street Hospital Top Child and Adolescent Health Study
- ClinicalTrials.gov ID
- NCT03564223
- Acronym / sponsor ID
- 18DD02
- Conditions
- Adolescent Behavior, Child Behavior, Parents
- Keywords
- Adolescent, Parental concerns, Child Health, Paediatrician Concerns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 20 Jun 2018 (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 Great Ormond Street Hospital (GOSH) Top child and adolescent health problems study aims to identify the top health concerns that parents/guardians and paediatricians in a tertiary hospital have for young people in England. 400 parents or guardians attending GOSH outpatients and 200 Paediatricians working at GOSH will be asked to rank a list of 30 child health concerns and results compared. Analysis will be done by demographics as well.
Detailed description
The GOSH top child and adolescent health problems study aims to identify the top health concerns that parents/guardians and paediatricians in a tertiary hospital have for young people in England. The study will be surveying parents/guardians and paediatricians at Great Ormond Street Hospital (GOSH), asking them to review and give their impressions from a list of thirty common child and adolescent health issues. Analysis of responses will provide a list of problems that are most important and determine if respondents feel that the NHS England is adequately addressing these problems.
The project was designed with public partnership. The investigators conducted literature reviews, and adopted with permission, a survey instrument used by the C.S. Mott Children's Hospital National Poll in Michigan, USA. Some parents were asked to list child and adolescent health problems that they deemed most important. A consensus meeting with experts was held, to select the thirty most common and important public health issues for young people in England, from which the study will identify problems with the highest concern. This project and its intended outcomes will span medical, nursing, research and voluntary services that will improve child and adolescent healthcare provision the UK.
The State of Child Health (SoCH) Report 2017 highlights indicators of child health problems across the four nations of the United Kingdom. There are some polls that were conducted in Australia and USA, investigating the top concerns for child health problems and thus providing a framework onto which to find solutions. The Royal Children's Hospital Melbourne through its National Child Health Poll established that that excessive screen time was the greatest parental concern, and that the top ten concerns related to modern lifestyle, mental health and child safety. Similarly, the C.S. Mott Children's Hospital National Poll on children's health selected a national sample of adults to identify health topics that are a "big problem" for children and teenagers. The 2017 report identified bullying/cyberbullying as the greatest concern. However there is no available evidence about studies being conducted in the United Kingdom to find out what parents/guardians and paediatricians report as the top child and adolescent health problems.
The information would be valuable to the health professionals at the point of care, as well as the national healthcare system. This study analyses information from groups on both the supply and demand side of child and adolescent healthcare. Understanding the different perceptions of child and adolescent health problems between healthcare professionals and parents/guardians can lead to improved follow-up care and compliance with advice. Information from this study can be used as a basis for the establishment of a UK national poll that would further investigate public concerns for child health.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents/Guardians | – | –Parents/Guardians aged over 18, attending Great Ormond Street Hospital Outpatients. Intervention: Administer questionnaire to review and decide on significance of each of 30 child health concerns |
| Paediatricians | – | –Paediatricians working at Great Ormond Street Hospital NHS Foundation Trust. Intervention: Administer questionnaire to review and decide on significance of each of 30 child health concerns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents/guardians attending GOSH OPD (nA) * Target Population = Yearly OPD attendance = 308,457 * Confidence Level is 95% * Margin of error = 5% * Target Sample Size = 384, approximately 400 * Sampling will be matched to attendance proportions in the six OPD areas - Cheetah, Manta ray, Rhino, Zebra, Hare and Hippo. Paediatricians (nB) * Target population = 400 Paediatricians at GOSH * Confidence Level is 95% * Margin of error = 5% * Target Sample Size = 197, approximately 200 * There will be no power calculation done. No statistical testing will be conducted
Key inclusion criteria (2 listed)
- Parents/Guardians attending GOSH NHS Foundation Trust Outpatients
- Paediatricians practicing at GOSH
Key exclusion criteria (6 listed)
- Parents/Guardians and Paediatricians outside the GOSH or NHS England
- Children aged under 18 years old
- Inpatients
- Parents/Guardians who cannot communicate in English and do not have an interpreter
- Participants who have previously responded to the questionnaire
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
Determination of Top 10 Child Health Concerns
Time frame: 12 Months
Ranking of Top Child Health Concerns by Parents and Paediatricians, which will obtained by asking both groups to state on a 4-point Likert scale on how they rate the significance of each of 30 child health concerns. 4 categorical ordinal responses from better to worse; Not a problem, small problem, moderate problem and large problem. These rankings will be analysed with weighted values assigned (0, 1, 2, 3). There is an option for I don't know. This will enable determination of top 10 child health concerns
Adequacy of NHS perceptions
Time frame: 12 Months
Parents and Paediatricians are asked to decide if they think the NHS is adequately addressing adolescent and child health issues, on a 5-point Likert scale rating agreement with the statement. 5 categorical ordinal responses from better to worse; Strongly agree, agree, neutral, disagree, strongly disagree. These rankings will be recoded in analysis as 'Disagree' (Strongly disagree, disagree) and 'Do not disagree' (Neutral, agree, strongly agree).
Determination of Top 3 information sources for parents and paediatricians
Time frame: 12 Months
Parents and Paediatricians are asked to list their top three information sources, and these will be analysed to determine the three most common sources of information for each group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Results publication: PubMed 22843294Garbutt JM, Leege E, Sterkel R, Gentry S, Wallendorf M, Strunk RC. What are parents worried about? Health problems and health concerns for children. Clin Pediatr (Phila). 2012 Sep;51(9):840-7. doi: 10.1177/0009922812455093. Epub 2012 Jul 26.
- C.S. Mott Poll for Top Child Health ConcernsLink provided by the sponsor.
- Royal Children's Hospital Melbourne Child Health PollLink provided by the sponsor.
- State of Child Health Report 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is currently no plan made to share IPD. This project is part of an educational project for the fulfillment of an MSc. Paediatrics and Child Health at University College London.
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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.
Vikram Palit principal investigator
Great Ormond Street Hospital Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior and Child Behavior, run by Institute of Child Health at 1 site in United Kingdom.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of Top 10 Child Health Concerns (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564223, which also lists 1 linked publication.
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 12 Apr 2024.