Sickle Cell DiseaseNCT02227472
Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of the impact the disease can have on the central nervous system. Specific impairments in working memory are particularly prevalent in school-aged children with SCD. Read more about this study
- Who is it for?
- Ages 48 to 68 months
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Evaluation of cognitive and pre-academic skills and Parent questionnaires
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2014to 20 Aug 2018
- 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 48 to 68 months
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be between 4 and 5 years of age, have a diagnosis of sickle cell disease (SCD) and be patients at St. Jude Children's Research Hospital.
Who may be able to join
- Patient at St. Jude Children's Research Hospital (SJCRH) with a primary diagnosis of sickle cell disease
- 48-68 months of age at time of enrollment
- English as primary language
Who cannot join
- Sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis)
- Treatment with non-stimulant psychotropic medication
- Enrollment in kindergarten at time of assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease: Family and Environmental Factors
Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of the impact the disease can have on the central nervous system. Specific impairments in working memory are particularly prevalent in school-aged children with SCD. Working memory is more strongly associated with school readiness and academic success than intellectual ability in the general population. The adverse effects of low socioeconomic status (SES) and poverty on cognition and neurodevelopment emerge early, before children have entered formal education. In addition, they affect language and executive function skills (e.g., working memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is associated with less parental stress, more supportive parenting practices, and better cognitive stimulation based on the availability of books, computers, and outings.
PRIMARY OBJECTIVE:
Read more
- To examine working memory and school readiness in young children with sickle cell disease in comparison to demographically matched control children without sickle cell disease.
SECONDARY OBJECTIVE:
- To examine the relationships of family/environmental factors (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity to working memory and school readiness skills in preschool-aged children with SCD.
Read the detailed description
Participants will be recruited through the Pediatric Sickle Cell Clinic at St. Jude. All participants with SCD will be evaluated once with laboratory measures of cognitive and pre-academic skills and parent questionnaires. Medical history will be evaluated for purposes of characterizing the health status and disease severity of patients and determining how medical factors are related to school readiness and working memory in SCD population. The study expects to accrue up to 99 participants with SCD.
Demographically-matched control children will be selected from a database of participants enrolled in an ongoing longitudinal study of neurocognitive development in children born in Shelby County, Tennessee. The control group will be randomly selected from an existing study group and will not be enrolled on the MEMREAD protocol. Control group participants will be excluded if they have any sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis), or if they have received treatment with non-stimulant psychotropic medication. A de-identified data file that includes the following results for up to 168 demographically-matched healthy control participants (approximately 1:2 ratio of SCD to healthy control) will be provided for control comparison purposes:
- Health Evaluation (CV4)
- Stanford binet - Fifth Edition (CV4)
- Bracken Basic Concepts Scale - Third Edition (CV4)
- The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) (CV4)
- The Scales of Independent Behavior - Revised, Early Development Form (SIB-R) (CV4)
- Demographics (CV4)
- Additional Covariates (if any) including gestational age at birth, developmental delays, major medical illnesses, surgery history, neurological event history, pre-kindergarten attendance, and daycare attendance
- Conditions
- Sickle Cell Disease
- Being tested
- Evaluation of cognitive and pre-academic skills, Parent questionnaires
- 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.
Evaluation of cognitive and pre-academic skillsOther
Also called Testing
Participants will complete testing to evaluate fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing, verbal and non-verbal working memory, and knowledge of pre-academic skills (such as colors, letters, numbers, counting, sizes, comparisons, and shapes).
Parent questionnairesOther
Also called Parent report
Parents will complete questionnaires to assess behavioral manifestation of executive functions, functional independence and adaptive functioning, child and parent characteristics, situational/demographic life stress, demographics, education level, and household income.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease | All participants who meet eligibility requirements and consent to the study will complete evaluation of cognitive and pre-academic skills, and parent questionnaires. Receives: Other: Evaluation of cognitive and pre-academic skills; Other: Parent questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in working memory between SCD participants and control group
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for working memory ability is the Working Memory Index from the SB-5. Primary dependent variables will be compared statistically using a paired sample one-side t-test.
Measured: Once, at enrollment
Mean difference in school readiness between SCD group and control group
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for school readiness is the School Readiness Composite from the BBCS. Primary dependent variables will be compared statistically using a paired sample one-side t-test.
Measured: Once, at enrollment
Association between working memory and school readiness skills compared between SCD group and control group
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. Bivariate correlations will be used to investigate the association between working memory and school readiness skills.
Measured: Once, at enrollment
Secondary outcomes (2)
Effect of family/environmental factors and disease severity on measures of working memory
Regression analyses will be used to examine the main effects of each family/environmental factor (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity factors on measures of working memory and school readiness.
Measured: Once, within 6 months of enrollment
Effect of family/environmental factors and disease severity on school readiness
Regression analyses will be used to examine the main effects of each family/environmental factor (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity factors on measures of working memory and school readiness.
Measured: Once, within 6 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start8 Sep 2014
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
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.
- More trials run by St. Jude Children's Research HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerlym Porter, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227472
- Sponsor's protocol ID
- MEMREAD
- Status last verified
- Sep 2018
- First submitted
- 22 Aug 2014
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease: Family and Environmental Factors
- ClinicalTrials.gov ID
- NCT02227472
- Acronym / sponsor ID
- MEMREAD
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 28 Aug 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.
Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of the impact the disease can have on the central nervous system. Specific impairments in working memory are particularly prevalent in school-aged children with SCD. Working memory is more strongly associated with school readiness and academic success than intellectual ability in the general population. The adverse effects of low socioeconomic status (SES) and poverty on cognition and neurodevelopment emerge early, before children have entered formal education. In addition, they affect language and executive function skills (e.g., working memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is associated with less parental stress, more supportive parenting practices, and better cognitive stimulation based on the availability of books, computers, and outings.
PRIMARY OBJECTIVE:
- To examine working memory and school readiness in young children with sickle cell disease in comparison to demographically matched control children without sickle cell disease.
SECONDARY OBJECTIVE:
- To examine the relationships of family/environmental factors (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity to working memory and school readiness skills in preschool-aged children with SCD.
Detailed description
Participants will be recruited through the Pediatric Sickle Cell Clinic at St. Jude. All participants with SCD will be evaluated once with laboratory measures of cognitive and pre-academic skills and parent questionnaires. Medical history will be evaluated for purposes of characterizing the health status and disease severity of patients and determining how medical factors are related to school readiness and working memory in SCD population. The study expects to accrue up to 99 participants with SCD.
Demographically-matched control children will be selected from a database of participants enrolled in an ongoing longitudinal study of neurocognitive development in children born in Shelby County, Tennessee. The control group will be randomly selected from an existing study group and will not be enrolled on the MEMREAD protocol. Control group participants will be excluded if they have any sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis), or if they have received treatment with non-stimulant psychotropic medication. A de-identified data file that includes the following results for up to 168 demographically-matched healthy control participants (approximately 1:2 ratio of SCD to healthy control) will be provided for control comparison purposes:
- Health Evaluation (CV4)
- Stanford binet - Fifth Edition (CV4)
- Bracken Basic Concepts Scale - Third Edition (CV4)
- The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) (CV4)
- The Scales of Independent Behavior - Revised, Early Development Form (SIB-R) (CV4)
- Demographics (CV4)
- Additional Covariates (if any) including gestational age at birth, developmental delays, major medical illnesses, surgery history, neurological event history, pre-kindergarten attendance, and daycare attendance
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease | – | Other: Evaluation of cognitive and pre-academic skills, Other: Parent questionnairesAll participants who meet eligibility requirements and consent to the study will complete evaluation of cognitive and pre-academic skills, and parent questionnaires. |
Who may qualify
- Ages
- 48 to 68 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be between 4 and 5 years of age, have a diagnosis of sickle cell disease (SCD) and be patients at St. Jude Children's Research Hospital.
Key inclusion criteria (3 listed)
- Patient at St. Jude Children's Research Hospital (SJCRH) with a primary diagnosis of sickle cell disease
- 48-68 months of age at time of enrollment
- English as primary language
Key exclusion criteria (3 listed)
- Sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis)
- Treatment with non-stimulant psychotropic medication
- Enrollment in kindergarten at time of assessment
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 |
|---|---|---|
| Evaluation of cognitive and pre-academic skillsAlso: TestingParticipants will complete testing to evaluate fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing, verbal and non-verbal working memory, and knowledge of pre-academic skills (such as colors, letters, numbers, counting, sizes, comparisons, and shapes). | Other | Sickle Cell Disease |
| Parent questionnairesAlso: Parent reportParents will complete questionnaires to assess behavioral manifestation of executive functions, functional independence and adaptive functioning, child and parent characteristics, situational/demographic life stress, demographics, education level, and household income. | Other | Sickle Cell Disease |
Primary outcome
Mean difference in working memory between SCD participants and control group
Time frame: Once, at enrollment
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for working memory ability is the Working Memory Index from the SB-5. Primary dependent variables will be compared statistically using a paired sample one-side t-test.
Mean difference in school readiness between SCD group and control group
Time frame: Once, at enrollment
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for school readiness is the School Readiness Composite from the BBCS. Primary dependent variables will be compared statistically using a paired sample one-side t-test.
Association between working memory and school readiness skills compared between SCD group and control group
Time frame: Once, at enrollment
Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. Bivariate correlations will be used to investigate the association between working memory and school readiness skills.
2 secondary outcomes
Effect of family/environmental factors and disease severity on measures of working memory
Time frame: Once, within 6 months of enrollment
Effect of family/environmental factors and disease severity on school readiness
Time frame: Once, within 6 months of enrollment
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 Sep 2018.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Jerlym Porter, PhD principal investigator
St. Jude Children's Research Hospital
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 Sickle Cell Disease, run by St. Jude Children's Research Hospital 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 3 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: finished, as of the sponsor's last update on 12 Sep 2018. 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 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?
Mean difference in working memory between SCD participants and control group (time frame: Once, at enrollment). 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?
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 Sep 2018.