<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227472</url>
  </required_header>
  <id_info>
    <org_study_id>MEMREAD</org_study_id>
    <nct_id>NCT02227472</nct_id>
  </id_info>
  <brief_title>Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease</brief_title>
  <official_title>Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease: Family and Environmental Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of&#xD;
      the impact the disease can have on the central nervous system. Specific impairments in&#xD;
      working memory are particularly prevalent in school-aged children with SCD. Working memory is&#xD;
      more strongly associated with school readiness and academic success than intellectual ability&#xD;
      in the general population. The adverse effects of low socioeconomic status (SES) and poverty&#xD;
      on cognition and neurodevelopment emerge early, before children have entered formal&#xD;
      education. In addition, they affect language and executive function skills (e.g., working&#xD;
      memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is&#xD;
      associated with less parental stress, more supportive parenting practices, and better&#xD;
      cognitive stimulation based on the availability of books, computers, and outings.&#xD;
&#xD;
      PRIMARY OBJECTIVE:&#xD;
&#xD;
        -  To examine working memory and school readiness in young children with sickle cell&#xD;
           disease in comparison to demographically matched control children without sickle cell&#xD;
           disease.&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
        -  To examine the relationships of family/environmental factors (caregiver stress, parental&#xD;
           responsiveness, and cognitive stimulation in the home) and disease severity to working&#xD;
           memory and school readiness skills in preschool-aged children with SCD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited through the Pediatric Sickle Cell Clinic at St. Jude. All&#xD;
      participants with SCD will be evaluated once with laboratory measures of cognitive and&#xD;
      pre-academic skills and parent questionnaires. Medical history will be evaluated for purposes&#xD;
      of characterizing the health status and disease severity of patients and determining how&#xD;
      medical factors are related to school readiness and working memory in SCD population. The&#xD;
      study expects to accrue up to 99 participants with SCD.&#xD;
&#xD;
      Demographically-matched control children will be selected from a database of participants&#xD;
      enrolled in an ongoing longitudinal study of neurocognitive development in children born in&#xD;
      Shelby County, Tennessee. The control group will be randomly selected from an existing study&#xD;
      group and will not be enrolled on the MEMREAD protocol. Control group participants will be&#xD;
      excluded if they have any sensory or motor impairment that would preclude valid testing&#xD;
      (e.g., blindness, paresis), or if they have received treatment with non-stimulant&#xD;
      psychotropic medication. A de-identified data file that includes the following results for up&#xD;
      to 168 demographically-matched healthy control participants (approximately 1:2 ratio of SCD&#xD;
      to healthy control) will be provided for control comparison purposes:&#xD;
&#xD;
        -  Health Evaluation (CV4)&#xD;
&#xD;
        -  Stanford binet - Fifth Edition (CV4)&#xD;
&#xD;
        -  Bracken Basic Concepts Scale - Third Edition (CV4)&#xD;
&#xD;
        -  The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) (CV4)&#xD;
&#xD;
        -  The Scales of Independent Behavior - Revised, Early Development Form (SIB-R) (CV4)&#xD;
&#xD;
        -  Demographics (CV4)&#xD;
&#xD;
        -  Additional Covariates (if any) including gestational age at birth, developmental delays,&#xD;
           major medical illnesses, surgery history, neurological event history, pre-kindergarten&#xD;
           attendance, and daycare attendance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2014</start_date>
  <completion_date type="Actual">August 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference in working memory between SCD participants and control group</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean difference in school readiness between SCD group and control group</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Association between working memory and school readiness skills compared between SCD group and control group</measure>
    <time_frame>Once, at enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of family/environmental factors and disease severity on measures of working memory</measure>
    <time_frame>Once, within 6 months of enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of family/environmental factors and disease severity on school readiness</measure>
    <time_frame>Once, within 6 months of enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Sickle Cell Disease</arm_group_label>
    <description>All participants who meet eligibility requirements and consent to the study will complete evaluation of cognitive and pre-academic skills, and parent questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of cognitive and pre-academic skills</intervention_name>
    <description>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).</description>
    <arm_group_label>Sickle Cell Disease</arm_group_label>
    <other_name>Testing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parent questionnaires</intervention_name>
    <description>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.</description>
    <arm_group_label>Sickle Cell Disease</arm_group_label>
    <other_name>Parent report</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be between 4 and 5 years of age, have a diagnosis of sickle cell disease&#xD;
        (SCD) and be patients at St. Jude Children's Research Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient at St. Jude Children's Research Hospital (SJCRH) with a primary diagnosis of&#xD;
             sickle cell disease&#xD;
&#xD;
          -  48-68 months of age at time of enrollment&#xD;
&#xD;
          -  English as primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensory or motor impairment that would preclude valid testing (e.g., blindness,&#xD;
             paresis)&#xD;
&#xD;
          -  Treatment with non-stimulant psychotropic medication&#xD;
&#xD;
          -  Enrollment in kindergarten at time of assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Months</minimum_age>
    <maximum_age>68 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerlym Porter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>September 11, 2018</last_update_submitted>
  <last_update_submitted_qc>September 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227472
org study id: MEMREAD
nct id: NCT02227472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Mean difference in working memory between SCD participants and control group
time frame: Once, at enrollment
description: 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.
measure: Mean difference in school readiness between SCD group and control group
time frame: Once, at enrollment
description: 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.
measure: Association between working memory and school readiness skills compared between SCD group and control group
time frame: Once, at enrollment
description: 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.
measure: Effect of family/environmental factors and disease severity on measures of working memory
time frame: Once, within 6 months of enrollment
description: 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.
measure: Effect of family/environmental factors and disease severity on school readiness
time frame: Once, within 6 months of enrollment
description: 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.
arm group label: Sickle Cell Disease
description: All participants who meet eligibility requirements and consent to the study will complete evaluation of cognitive and pre-academic skills, and parent questionnaires.
intervention type: Other
intervention name: Evaluation of cognitive and pre-academic skills
description: 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).
arm group label: Sickle Cell Disease
other name: Testing
intervention type: Other
intervention name: Parent questionnaires
description: 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.
arm group label: Sickle Cell Disease
other name: Parent report
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 48 Months
maximum age: 68 Months
healthy volunteers: No
last name: Jerlym Porter, PhD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell