Sickle Cell DiseaseNCT06251843
Support Strategies for Parents During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder
An observational study of Sickle Cell Disease, run by King's College London at 2 sites in United Kingdom.
Trial summary
Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Jun 2024to 31 Jul 2025
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents whose children have been diagnosed with SCD via screening in the last 36 months Health professionals involved in the care of children with sickle cell disorder
Who may be able to join
- Parents whose children have been diagnosed with SCD via screening in the last 36 months
- Health professionals involved in the care of children with sickle cell disorder
Who cannot join
- Parents whose inclusion may be contradicted on psychosocial grounds or who are unable to give informed consent.
- Health professionals who do not have experience of caring for children with sickle cell disorder.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Alder Hey Children's Hospital
Liverpool
Guy's and St Thomas' NHS Foundation Trust
London
About this study
Official title: Co-designing Support Strategies for Parents to Encourage Early Engagement With Health Services During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder
Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support.
Aim: Develop strategies to improve support for parents during their child's first year of life following a SCD diagnosis to encourage early engagement with health services.
Read more
Method: Comprises two stages: (i) Determine why parents choose to engage with support or not (ii) Use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life.
Patient and Public Involvement: We are working with Sickle Cell Society and parents of children with SCD. Dissemination: Findings will be shared with support groups, charities, health professionals and academics.
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, SCD, sickle cell anaemia
- Medical subject headings
- Anemia, Sickle Cell
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 sickle cell disorder | Parents whose child has been diagnosed with sickle cell disorder in the last 36 months | |
| Health professionals | Health professionals involved in the care of children sickle cell disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support strategies for families with a child with SCD
Co-design strategies to ensure greater accessibility of support for parents during their child's first year of life following a SCD diagnosis
Measured: June 2025
Secondary outcomes (3)
Existing support
Description of support strategies accessed nationally by parents during the first year following their child's SCD diagnosis
Measured: July 2024
Parental reasons for accessing support
Reasons why parents choose to access support or not
Measured: July 2024
Support priorities
priorities for improving accessibility to support for parents during their child's first year of life following a SCD diagnosis for the co-design groups
Measured: Sept 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start28 Jun 2024
- Primary completion31 Mar 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- British Academy, Sickle Cell Society, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251843
- Sponsor's protocol ID
- Support_SCD
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-designing Support Strategies for Parents to Encourage Early Engagement With Health Services During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder
- ClinicalTrials.gov ID
- NCT06251843
- Acronym / sponsor ID
- Support_SCD
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, SCD, sickle cell anaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- British Academy, Sickle Cell Society, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 9 Feb 2024 (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.
Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support.
Aim: Develop strategies to improve support for parents during their child's first year of life following a SCD diagnosis to encourage early engagement with health services.
Method: Comprises two stages: (i) Determine why parents choose to engage with support or not (ii) Use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life.
Patient and Public Involvement: We are working with Sickle Cell Society and parents of children with SCD. Dissemination: Findings will be shared with support groups, charities, health professionals and academics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of children with sickle cell disorder | – | –Parents whose child has been diagnosed with sickle cell disorder in the last 36 months |
| Health professionals | – | –Health professionals involved in the care of children sickle cell disorder |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents whose children have been diagnosed with SCD via screening in the last 36 months Health professionals involved in the care of children with sickle cell disorder
Key inclusion criteria (2 listed)
- Parents whose children have been diagnosed with SCD via screening in the last 36 months
- Health professionals involved in the care of children with sickle cell disorder
Key exclusion criteria (2 listed)
- Parents whose inclusion may be contradicted on psychosocial grounds or who are unable to give informed consent.
- Health professionals who do not have experience of caring for children with sickle cell disorder.
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
Support strategies for families with a child with SCD
Time frame: June 2025
Co-design strategies to ensure greater accessibility of support for parents during their child's first year of life following a SCD diagnosis
3 secondary outcomes
Existing support
Time frame: July 2024
Parental reasons for accessing support
Time frame: July 2024
Support priorities
Time frame: Sept 2025
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 7 Aug 2026.
- Individual participant dataSharing planned: Undecided. To be decided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by King's College London at 2 sites 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 2 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Support strategies for families with a child with SCD (time frame: June 2025). 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 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.