Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention
NCT ID: NCT06562439
Last Updated: 2024-08-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-01-01
Study Completion Date
2028-07-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Sickle Cell Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
We will randomize children to receive developmental screening alone or developmental screening with a home-based intervention.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Developmental Screening
Participants in this group will complete developmental screening at 9, 18, and 30 months of age.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Developmental Screening + Home-Based Intervention
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.
Group Type
EXPERIMENTAL
Sickle Cell Collaboration for Child Development
Intervention Type
BEHAVIORAL
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.
Interventions
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Sickle Cell Collaboration for Child Development
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
Minimum Eligible Age
6 Months
Maximum Eligible Age
31 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Sanger M, Jordan L, Pruthi S, Day M, Covert B, Merriweather B, Rodeghier M, DeBaun M, Kassim A. Cognitive deficits are associated with unemployment in adults with sickle cell anemia. J Clin Exp Neuropsychol. 2016 Aug;38(6):661-71. doi: 10.1080/13803395.2016.1149153.
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BACKGROUND
Aygun B, Parker J, Freeman MB, Stephens AL, Smeltzer MP, Wu S, Hankins JS, Wang WC. Neurocognitive screening with the Brigance preschool screen-II in 3-year-old children with sickle cell disease. Pediatr Blood Cancer. 2011 Apr;56(4):620-4. doi: 10.1002/pbc.22833. Epub 2010 Nov 11.
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BACKGROUND
Farber MD, Koshy M, Kinney TR. Cooperative Study of Sickle Cell Disease: Demographic and socioeconomic characteristics of patients and families with sickle cell disease. J Chronic Dis. 1985;38(6):495-505. doi: 10.1016/0021-9681(85)90033-5.
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BACKGROUND
Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.
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BACKGROUND
Ohene-Frempong K, Weiner SJ, Sleeper LA, Miller ST, Embury S, Moohr JW, Wethers DL, Pegelow CH, Gill FM. Cerebrovascular accidents in sickle cell disease: rates and risk factors. Blood. 1998 Jan 1;91(1):288-94.
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BACKGROUND
Piel FB, Steinberg MH, Rees DC. Sickle Cell Disease. N Engl J Med. 2017 Apr 20;376(16):1561-1573. doi: 10.1056/NEJMra1510865. No abstract available.
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BACKGROUND
Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCCCD.SRP.OT
Identifier Type: -
Identifier Source: org_study_id
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