Sickle Cell DiseaseSCCCDNCT06562439
Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
A study testing Sickle Cell Collaboration for Child Development in people with Sickle Cell Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. Read more about this study
- Who is it for?
- Ages 6 to 31 months
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Sickle Cell Collaboration for Child Development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- 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 6 to 31 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All sickle cell disease genotypes will be included. Children will be eligible to participate until they reach 31 months of age (1 month over target evaluation).
Who cannot join
- Children will be excluded if the child has fragile health, a diagnosis associated with developmental deficit (not sickle cell disease), or the family is not English language proficient -because of limitations in alternative language assessment and intervention delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Early Identification and Intervention Of Developmental Delay Among Infants And Toddlers With Sickle Cell Disease Using the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9, 18 and 30 months of age among children with sickle cell disease and test a 12-month, home-based caregiver intervention with this disproportionately affected population.
Read the detailed description
This trial will be conducted in two phases. In Aim 1, the investigators are evaluating the developmental progress of children with and without sickle cell disease (SCD) at 9, 18, and 30 months. The investigators aim to recruit a total of 100 children and their caregivers (SCD = 50, Comparison = 50). Each child/caregiver dyad will be asked to complete 3 evaluation visits where the child's developmental progress will be evaluated and the caregiver will complete surveys related to their child's development, participation, and the caregiver's mental health.
In Aim 2, children with sickle cell disease will be randomized to receive developmental evaluations at 9, 18, and 30 months alone or a 12-month home-based intervention + developmental evaluations. The intervention is called the Sickle Cell Collaboration for Child Development (SCCCD) uses the widely used Parents as Teachers curriculum and is supplemented with specific support for the caregivers related to the child's sickle cell diagnosis. This pilot randomized controlled trial design is designed to (1) examine the potential effects of SCCCD on child development and caregiver well-being compared to the group with no intervention and (2) optimize trial procedures to enhance acceptability and scalability in preparation for a full-scale trial. Data will be collected to explore determinants (facilitators and barriers) affecting participation and outcomes. The investigators will recruit 50 children with sickle cell disease to this aim, with the goal to have 25 children randomized to intervention. Randomization will be completed using a random computer generator that can balance groups based on key factors like age, sex, and area deprivation index (index approximating income and community resources).
Participants randomized to SCCCD (n=25) will be invited to participate in 12 home-based intervention session over the course of 1 year (1 visit monthly) with a trained parent educator. They will complete the visit according to the Parents as Teachers curriculum and will provide additional discussion focused on sickle cell disease and strategies to promote child development. If caregivers are uncomfortable with home-visits, families will have the option to complete intervention visits in our on-site clinic space or in a preferred community location (e.g., public library, child care setting, place of worship). Participants in the developmental evaluation group will complete study visits as described in Aim 1.
The primary outcomes are child development and caregiver acceptability of developmental screening and intervention. The investigators will use implementation strategies guided by our earlier work to optimize the program's feasibility which will be measured by tracking participation and retention rates in each phase of this study. Acceptability will be assessed through interviews and surveys.
- Conditions
- Sickle Cell Disease
- Being tested
- Sickle Cell Collaboration for Child Development
- Keywords
- child development, developmental delay, parents as teachers, home based intervention
- Medical subject headings
- Anemia, Sickle Cell, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sickle Cell Collaboration for Child DevelopmentBehavioural
The Sickle Cell Collaboration for Child Development (SCCCD) combines the Parents as Teachers curriculum with experienced occupational therapy to help families and children meet their learning and developmental goals.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Screening | No intervention | Participants in this group will complete developmental screening at 9, 18, and 30 months of age. |
| Developmental Screening + Home-Based Intervention | Experimental | Participants in this group will complete developmental screening at 9, 18 and 30 months of age and monthly home visits with the family using the Parents as Teachers curriculum. Receives: Behavioral: Sickle Cell Collaboration for Child Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant Toddler Development-IV
Child participants will complete up to 3 developmental evaluations with a trained evaluator using the Bayley Scales of Infant Toddler Development-IV. The Bayley assesses development in the domains of cognition, fine and gross motor, and expressive and receptive language. Caregiver questionnaires assess adaptive behavior and social emotional development. Scaled scores range from 1-19, where a score of 10 is average and a higher score indicates better outcome.
Measured: Completed at 9, 18 and 30 months
Ages and Stages Questionnaire-3
Caregivers will complete the Ages and Stages Questionnaire-3, which assesses the caregivers perspective of how their child is meeting developmental milestones in the domains of communication, gross motor, fine motor, personal-social and problem solving. Scores range from 0-60, where a higher score indicates a better outcome.
Measured: Completed at 9, 18 and 30 months
Infant Toddler Activity Card Sort
Caregivers will complete the Infant Toddler Activity Card Sort (ITACS) to determine activities and routines that are presenting performance or participation challenges for families in the context of their everyday lives.
Measured: Completed at 9, 18 and 30 months
Behavior Rating Inventory of Executive Function-Preschool
The Behavior Rating Inventory of Executive Function-Preschool (BRIEF) evaluates executive functioning of toddlers >2.5 years. Executive functioning is identified as a high risk domain for deficits among individuals with sickle cell disease. Raw scores are converted to t-scores (mean = 50, SD = 10) and scores above 65 are considered clinically significant.
Measured: 30 months of age
Secondary outcomes (3)
PROMIS Depression (Caregiver)
The Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression short form is a valid and reliable 8-item tool to screen for depression. Scores range from 8-40, with higher scores indicating more severe depression symptoms.
Measured: Completed at child's 9, 18 and 30 month evaluation.
Acceptability
Study visit completion rates and notes from intervention visits will be reviewed. Interviews will be conducted with all participants in the SCCCD intervention, regardless of completion to determine components that contributed to participation or attrition.
Measured: through study completion, an average of 1 year
Fidelity
The Comprehensive Intervention Fidelity Guide will be used to evaluate intervention design, training and delivery. This guide specifies the intervention model, the fidelity indices (e.g., participation and retention rates) and compare those to outcome measures.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Why it stopped: not a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- We will randomize children to receive developmental screening alone or developmental screening with a home-based intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562439
- Sponsor's protocol ID
- SCCCD.SRP.OT
- Other IDs
- K23HL161328
- Acronym
- SCCCD
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Findings from this proposal will be disseminated in peer-reviewed publications and at scholarly meetings following best practices guidelines (e.g., Equator network guidelines).
Publications
Brownson RC, Proctor EK, Luke DA, Baumann AA, Staub M, Brown MT, Johnson M. Building capacity for dissemination and implementation research: one university's experience. Implement Sci. 2017 Aug 16;12(1):104. doi: 10.1186/s13012-017-0634-4.
PubMed 28814328Campbell FA, Ramey CT. Effects of early intervention on intellectual and academic achievement: a follow-up study of children from low-income families. Child Dev. 1994 Apr;65(2 Spec No):684-98.
PubMed 8013248Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000 Aug;23(4):334-40. doi: 10.1002/1098-240x(200008)23:43.0.co;2-g.
PubMed 10940958Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
PubMed 34785096Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Nilsen P, Bernhardsson S. Context matters in implementation science: a scoping review of determinant frameworks that describe contextual determinants for implementation outcomes. BMC Health Serv Res. 2019 Mar 25;19(1):189. doi: 10.1186/s12913-019-4015-3.
PubMed 30909897Toomey E, Hardeman W, Hankonen N, Byrne M, McSharry J, Matvienko-Sikar K, Lorencatto F. Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions. Health Psychol Behav Med. 2020 Mar 12;8(1):132-151. doi: 10.1080/21642850.2020.1738935.
PubMed 34040865Nelson MC, Cordray DS, Hulleman CS, Darrow CL, Sommer EC. A procedure for assessing intervention fidelity in experiments testing educational and behavioral interventions. J Behav Health Serv Res. 2012 Oct;39(4):374-96. doi: 10.1007/s11414-012-9295-x.
PubMed 22935907Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.
PubMed 21130938Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.
PubMed 24931848Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
PubMed 21697139Hoyt CR, L'Hotta AJ, Bauer AH, Chang CH, Varughese TE, Abel RA, King AA. Activity competence among infants and toddlers with developmental disabilities: Rasch analysis of the Infant Toddler Activity Card Sort (ITACS). J Patient Rep Outcomes. 2021 Jan 21;5(1):14. doi: 10.1186/s41687-021-00287-0.
PubMed 33475869Schatz J, Roberts CW. Neurobehavioral impact of sickle cell disease in early childhood. J Int Neuropsychol Soc. 2007 Nov;13(6):933-43. doi: 10.1017/S1355617707071196.
PubMed 17942011
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Intervention Of Developmental Delay Among Infants And Toddlers With Sickle Cell Disease Using the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
- ClinicalTrials.gov ID
- NCT06562439
- Acronym / sponsor ID
- SCCCD / SCCCD.SRP.OT
- Conditions
- Sickle Cell Disease
- Keywords
- child development, developmental delay, parents as teachers, home based intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Aug 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.
Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9, 18 and 30 months of age among children with sickle cell disease and test a 12-month, home-based caregiver intervention with this disproportionately affected population.
Detailed description
This trial will be conducted in two phases. In Aim 1, the investigators are evaluating the developmental progress of children with and without sickle cell disease (SCD) at 9, 18, and 30 months. The investigators aim to recruit a total of 100 children and their caregivers (SCD = 50, Comparison = 50). Each child/caregiver dyad will be asked to complete 3 evaluation visits where the child's developmental progress will be evaluated and the caregiver will complete surveys related to their child's development, participation, and the caregiver's mental health.
In Aim 2, children with sickle cell disease will be randomized to receive developmental evaluations at 9, 18, and 30 months alone or a 12-month home-based intervention + developmental evaluations. The intervention is called the Sickle Cell Collaboration for Child Development (SCCCD) uses the widely used Parents as Teachers curriculum and is supplemented with specific support for the caregivers related to the child's sickle cell diagnosis. This pilot randomized controlled trial design is designed to (1) examine the potential effects of SCCCD on child development and caregiver well-being compared to the group with no intervention and (2) optimize trial procedures to enhance acceptability and scalability in preparation for a full-scale trial. Data will be collected to explore determinants (facilitators and barriers) affecting participation and outcomes. The investigators will recruit 50 children with sickle cell disease to this aim, with the goal to have 25 children randomized to intervention. Randomization will be completed using a random computer generator that can balance groups based on key factors like age, sex, and area deprivation index (index approximating income and community resources).
Participants randomized to SCCCD (n=25) will be invited to participate in 12 home-based intervention session over the course of 1 year (1 visit monthly) with a trained parent educator. They will complete the visit according to the Parents as Teachers curriculum and will provide additional discussion focused on sickle cell disease and strategies to promote child development. If caregivers are uncomfortable with home-visits, families will have the option to complete intervention visits in our on-site clinic space or in a preferred community location (e.g., public library, child care setting, place of worship). Participants in the developmental evaluation group will complete study visits as described in Aim 1.
The primary outcomes are child development and caregiver acceptability of developmental screening and intervention. The investigators will use implementation strategies guided by our earlier work to optimize the program's feasibility which will be measured by tracking participation and retention rates in each phase of this study. Acceptability will be assessed through interviews and surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will randomize children to receive developmental screening alone or developmental screening with a home-based intervention.
| Arm | Type | Receives |
|---|---|---|
| Developmental Screening | No intervention | –Participants in this group will complete developmental screening at 9, 18, and 30 months of age. |
| Developmental Screening + Home-Based Intervention | Experimental | Behavioral: Sickle Cell Collaboration for Child DevelopmentParticipants in this group will complete developmental screening at 9, 18 and 30 months of age and monthly home visits with the family using the Parents as Teachers curriculum. |
Who may qualify
- Ages
- 6 to 31 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All sickle cell disease genotypes will be included. Children will be eligible to participate until they reach 31 months of age (1 month over target evaluation).
Key exclusion criteria (1 listed)
- Children will be excluded if the child has fragile health, a diagnosis associated with developmental deficit (not sickle cell disease), or the family is not English language proficient -because of limitations in alternative language assessment and intervention delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sickle Cell Collaboration for Child DevelopmentThe Sickle Cell Collaboration for Child Development (SCCCD) combines the Parents as Teachers curriculum with experienced occupational therapy to help families and children meet their learning and developmental goals. | Behavioural | Developmental Screening + Home-Based Intervention |
Primary outcome
Bayley Scales of Infant Toddler Development-IV
Time frame: Completed at 9, 18 and 30 months
Child participants will complete up to 3 developmental evaluations with a trained evaluator using the Bayley Scales of Infant Toddler Development-IV. The Bayley assesses development in the domains of cognition, fine and gross motor, and expressive and receptive language. Caregiver questionnaires assess adaptive behavior and social emotional development. Scaled scores range from 1-19, where a score of 10 is average and a higher score indicates better outcome.
Ages and Stages Questionnaire-3
Time frame: Completed at 9, 18 and 30 months
Caregivers will complete the Ages and Stages Questionnaire-3, which assesses the caregivers perspective of how their child is meeting developmental milestones in the domains of communication, gross motor, fine motor, personal-social and problem solving. Scores range from 0-60, where a higher score indicates a better outcome.
Infant Toddler Activity Card Sort
Time frame: Completed at 9, 18 and 30 months
Caregivers will complete the Infant Toddler Activity Card Sort (ITACS) to determine activities and routines that are presenting performance or participation challenges for families in the context of their everyday lives.
Behavior Rating Inventory of Executive Function-Preschool
Time frame: 30 months of age
The Behavior Rating Inventory of Executive Function-Preschool (BRIEF) evaluates executive functioning of toddlers >2.5 years. Executive functioning is identified as a high risk domain for deficits among individuals with sickle cell disease. Raw scores are converted to t-scores (mean = 50, SD = 10) and scores above 65 are considered clinically significant.
3 secondary outcomes
PROMIS Depression (Caregiver)
Time frame: Completed at child's 9, 18 and 30 month evaluation.
Acceptability
Time frame: through study completion, an average of 1 year
Fidelity
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 28814328Brownson RC, Proctor EK, Luke DA, Baumann AA, Staub M, Brown MT, Johnson M. Building capacity for dissemination and implementation research: one university's experience. Implement Sci. 2017 Aug 16;12(1):104. doi: 10.1186/s13012-017-0634-4.
- Background: PubMed 8013248Campbell FA, Ramey CT. Effects of early intervention on intellectual and academic achievement: a follow-up study of children from low-income families. Child Dev. 1994 Apr;65(2 Spec No):684-98.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Background: PubMed 10940958Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000 Aug;23(4):334-40. doi: 10.1002/1098-240x(200008)23:43.0.co;2-g.
- Background: PubMed 34785096Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Background: PubMed 30909897Nilsen P, Bernhardsson S. Context matters in implementation science: a scoping review of determinant frameworks that describe contextual determinants for implementation outcomes. BMC Health Serv Res. 2019 Mar 25;19(1):189. doi: 10.1186/s12913-019-4015-3.
- Background: PubMed 34040865Toomey E, Hardeman W, Hankonen N, Byrne M, McSharry J, Matvienko-Sikar K, Lorencatto F. Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions. Health Psychol Behav Med. 2020 Mar 12;8(1):132-151. doi: 10.1080/21642850.2020.1738935.
- Background: PubMed 22935907Nelson MC, Cordray DS, Hulleman CS, Darrow CL, Sommer EC. A procedure for assessing intervention fidelity in experiments testing educational and behavioral interventions. J Behav Health Serv Res. 2012 Oct;39(4):374-96. doi: 10.1007/s11414-012-9295-x.
- Background: PubMed 21130938Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.
- Background: PubMed 24931848Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Individual participant dataSharing planned: No. Findings from this proposal will be disseminated in peer-reviewed publications and at scholarly meetings following best practices guidelines (e.g., Equator network guidelines).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sickle Cell Collaboration for Child Development in people with Sickle Cell Disease, run by Washington University School of Medicine at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 25 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 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Bayley Scales of Infant Toddler Development-IV (time frame: Completed at 9, 18 and 30 months). The study lists 4 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 NCT06562439, which also lists 70 linked publications.
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 25 Aug 2026.