Hemoglobin SC DiseaseNCT00860782
Parent Educational Program for Children With Sickle Cell Disease
A study testing Parent Educational Support in people with Hemoglobin SC Disease and Anemia, Sickle Cell, run by University of Miami at 1 site in United States.
Trial summary
Children with sickle cell disease (SCD) are at risk for central nervous system (CNS) complications, which may affect academic achievement. This study will evaluate an educational support program for parents that aims to improve academic achievement in children with SCD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemoglobin SC Disease, Anemia, Sickle Cell
- What is being tested?
- Parent Educational Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2016
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with either HbSS (sickle cell anemia) or HbSβ-thal (hemoglobin S beta thalassemia) who are between 6 and 12 years of age
- Child's parent or primary caregiver agrees to participate in the study
Who cannot join
- Child is monolingual in a language other than English and cannot complete standardized testing in English
- Parent or caregiver of the child is not fluent in English or Spanish
- Child has some other developmental disability not related to SCD. This would include Down's syndrome, autism, pervasive developmental disability, cerebral palsy, seizure disorder, consequences of severe prematurity, or a documented closed head injury that resulted in loss of consciousness.
- Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mailman Center for Child Development
Miami, Florida, 33131
About this study
Official title: Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease
Children with sickle cell disease (SCD) are at risk for central nervous system (CNS) complications, which may affect academic achievement. This study will evaluate an educational support program for parents that aims to improve academic achievement in children with SCD.
Read the detailed description
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin-the protein in red blood cells that carries oxygen to tissues. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." Children with SCD are also at risk for a variety of CNS complications, including various types of stroke and increased blood flow to the brain. These conditions affect neuropsychological performance and academic achievement. In children with SCD, there may also be a relationship between CNS complications, behavioral problems, family environment stressors, and pain symptoms. For example, children with SCD-related CNS complications have a higher risk of developing behavioral problems than children without SCD. In turn, behavioral problems are associated with high levels of family conflict and can be a significant stressor for families coping with SCD. This kind of stress can then lead to increased difficulty in dealing with SCD symptoms, particularly pain, for the child. This study will evaluate an educational support program for parents of children with SCD, conducted either once a year or four times a year, in terms of the program's effect on children's academic achievement. In addition, study researchers will also evaluate the program's effect on behavioral difficulties, pain frequency, and the family environment.
This study will enroll children with HbSS (sickle cell anemia) or HbSb-thal (hemoglobin S beta thalassemia) SCD. Parents or caregivers of participants will be randomly assigned to attend the educational support program meetings either once a year or four times a year for 2 years. The educational meetings with the parent/caregiver will be 45 minutes long and will cover the following four main areas:
- Provide education regarding the learning issues often seen with children with SCD
- Provide information regarding special education services in the school system and how the parent can obtain academic support for his/her child
- Provide information on how to assist the child to better manage homework
- Evaluate the child's current level of pain and how pain may affect school attendance
There will be three evaluation timepoints. At baseline and Year 3, children will undergo a neurodevelopmental evaluation, including academic achievement tests. The parent and child will complete questionnaires on emotional and behavioral functioning, stress levels, and family functioning. At Year 2, the children will complete academic achievement tests, and the questionnaires for the parent and child will be repeated.
- Conditions
- Hemoglobin SC Disease, Anemia, Sickle Cell
- Being tested
- Parent Educational Support
- Keywords
- Sickle Cell Disease, Educational Outcomes, Neurodevelopmental Functioning
- Medical subject headings
- Hemoglobin SC Disease, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Educational SupportBehavioural
Parents will attend 45-minute educational sessions that will focus on providing them with information regarding SCD and how they can best help their child perform better in school.
| Study group | Role | What they receive |
|---|---|---|
| Annual Parent Intervention (API) Group | Experimental | Participants in this group will receive the parent educational support intervention once a year for 2 years. Receives: Behavioral: Parent Educational Support |
| Quarterly Parent Intervention (QPI) Group | Experimental | Participants in this group will receive the parent educational support intervention quarterly (4 times a year) for 2 years. Receives: Behavioral: Parent Educational Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition
Performance on standardized measure of academic achievement, M=100, SD=15
Measured: Measured at baseline and Years 2 and 3
Secondary outcomes (1)
Child's emotional and behavioral functioning, parental stress, and family functioning
Standardized parent report quesionnaires of child adjustment, parent stress, and family function
Measured: Measured at baseline and Years 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemoglobin SC 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Daniel F. Armstrong, University of Miami
- Investigators
- Daniel Armstrong, PhD, Study director, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860782
- Sponsor's protocol ID
- 20080278
- Other IDs
- U54HL090569, U54HL090569-01
- Status last verified
- Jul 2021
- First submitted
- 10 Mar 2009
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following final data analysis and dissemination, the SAP and ICF will be shared with investigators requesting these materials.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Intervention to Improve Academic Success in Children With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00860782
- Acronym / sponsor ID
- 20080278
- Conditions
- Hemoglobin SC Disease, Anemia, Sickle Cell
- Keywords
- Sickle Cell Disease, Educational Outcomes, Neurodevelopmental Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2008 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Mar 2009 (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 central nervous system (CNS) complications, which may affect academic achievement. This study will evaluate an educational support program for parents that aims to improve academic achievement in children with SCD.
Detailed description
SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin-the protein in red blood cells that carries oxygen to tissues. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." Children with SCD are also at risk for a variety of CNS complications, including various types of stroke and increased blood flow to the brain. These conditions affect neuropsychological performance and academic achievement. In children with SCD, there may also be a relationship between CNS complications, behavioral problems, family environment stressors, and pain symptoms. For example, children with SCD-related CNS complications have a higher risk of developing behavioral problems than children without SCD. In turn, behavioral problems are associated with high levels of family conflict and can be a significant stressor for families coping with SCD. This kind of stress can then lead to increased difficulty in dealing with SCD symptoms, particularly pain, for the child. This study will evaluate an educational support program for parents of children with SCD, conducted either once a year or four times a year, in terms of the program's effect on children's academic achievement. In addition, study researchers will also evaluate the program's effect on behavioral difficulties, pain frequency, and the family environment.
This study will enroll children with HbSS (sickle cell anemia) or HbSb-thal (hemoglobin S beta thalassemia) SCD. Parents or caregivers of participants will be randomly assigned to attend the educational support program meetings either once a year or four times a year for 2 years. The educational meetings with the parent/caregiver will be 45 minutes long and will cover the following four main areas:
- Provide education regarding the learning issues often seen with children with SCD
- Provide information regarding special education services in the school system and how the parent can obtain academic support for his/her child
- Provide information on how to assist the child to better manage homework
- Evaluate the child's current level of pain and how pain may affect school attendance
There will be three evaluation timepoints. At baseline and Year 3, children will undergo a neurodevelopmental evaluation, including academic achievement tests. The parent and child will complete questionnaires on emotional and behavioral functioning, stress levels, and family functioning. At Year 2, the children will complete academic achievement tests, and the questionnaires for the parent and child will be repeated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annual Parent Intervention (API) Group | Experimental | Behavioral: Parent Educational SupportParticipants in this group will receive the parent educational support intervention once a year for 2 years. |
| Quarterly Parent Intervention (QPI) Group | Experimental | Behavioral: Parent Educational SupportParticipants in this group will receive the parent educational support intervention quarterly (4 times a year) for 2 years. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with either HbSS (sickle cell anemia) or HbSβ-thal (hemoglobin S beta thalassemia) who are between 6 and 12 years of age
- Child's parent or primary caregiver agrees to participate in the study
Key exclusion criteria (4 listed)
- Child is monolingual in a language other than English and cannot complete standardized testing in English
- Parent or caregiver of the child is not fluent in English or Spanish
- Child has some other developmental disability not related to SCD. This would include Down's syndrome, autism, pervasive developmental disability, cerebral palsy, seizure disorder, consequences of severe prematurity, or a documented closed head injury that resulted in loss of consciousness.
- Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.
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 |
|---|---|---|
| Parent Educational SupportParents will attend 45-minute educational sessions that will focus on providing them with information regarding SCD and how they can best help their child perform better in school. | Behavioural | Annual Parent Intervention (API) Group, Quarterly Parent Intervention (QPI) Group |
Primary outcome
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition
Time frame: Measured at baseline and Years 2 and 3
Performance on standardized measure of academic achievement, M=100, SD=15
1 secondary outcome
Child's emotional and behavioral functioning, parental stress, and family functioning
Time frame: Measured at baseline and Years 2 and 3
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 2 Aug 2021.
- Individual participant dataSharing planned: No. Following final data analysis and dissemination, the SAP and ICF will be shared with investigators requesting these materials.
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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.
Daniel Armstrong, PhD study director
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Educational Support in people with Hemoglobin SC Disease and Anemia, Sickle Cell, run by University of Miami 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 2 inclusion and 4 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 2 Aug 2021. 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?
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition (time frame: Measured at baseline and Years 2 and 3). 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 2 Aug 2021.