Caregiver Program for Sickle Cell Disease

(SCCCD Trial)

Not yet recruiting at 1 trial location

Overseen By Catherine R Hoyt, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Fragile health, Non-English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand developmental delays in young children with sickle cell disease, a condition affecting the blood. It will examine the prevalence and severity of these delays at 9, 18, and 30 months of age. Two groups will participate: one will undergo developmental screenings only, while the other will also receive home-based support through the Sickle Cell Collaboration for Child Development program. Children with sickle cell disease who do not have other health issues affecting development and whose families speak English may be suitable candidates. As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance developmental support for children with sickle cell disease.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this caregiver program is safe for children with sickle cell disease?

Research shows that this study involves a home-based program for children with sickle cell disease, focusing on early childhood development. The program uses the "Parents as Teachers" curriculum. As it is not a drug treatment, there are no concerns about side effects or adverse reactions common with medications.

The program's safety stems from its role as a supportive educational tool, not a medical treatment. It is generally well-received. Families receive guidance and support through regular home visits, which aim to improve children's development without any risk to their physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how early developmental screenings combined with home-based interventions can support children with Sickle Cell Disease. Unlike typical treatments that focus mainly on managing symptoms and preventing complications, this approach targets the developmental challenges that can arise from the disease. By using the "Parents as Teachers" curriculum during home visits, the trial aims to provide personalized support to families, potentially enhancing the child's developmental outcomes in ways current medical treatments alone might not achieve.

What evidence suggests that this caregiver program is effective for sickle cell disease?

Research has shown that early intervention can greatly benefit children with sickle cell disease who might face developmental delays. In this trial, one group of participants will receive developmental screening at 9, 18, and 30 months of age. Another group will receive both developmental screening and monthly home visits using the "Parents as Teachers" curriculum to guide families. One study found that a program teaching parents how to support their child's growth improved development in young children with this condition. This program focuses on showing caregivers how to effectively encourage their child's development. Early results suggest that this kind of support can lead to better outcomes for these children. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children under the age of 3 with sickle cell disease, who may be at risk for developmental deficits. Caregivers willing to participate in a home-based intervention program are also included.

Inclusion Criteria

I have sickle cell disease, regardless of the specific type.

My child is younger than 31 months old.

Exclusion Criteria

Children will be excluded if the family is not English language proficient - because of limitations in alternative language assessment and intervention delivery.

Children will be excluded if the child has fragile health

My child does not have a developmental deficit diagnosis other than sickle cell disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Developmental Evaluation

Children undergo developmental evaluations at 9, 18, and 30 months of age

21 months

3 visits (in-person)

Home-Based Intervention

Participants receive a 12-month home-based intervention using the Parents as Teachers curriculum

12 months

12 visits (monthly, in-person or community location)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sickle Cell Collaboration for Child Development

Trial Overview The study aims to identify how often and severely developmental deficits occur in young children with sickle cell disease by monitoring them at different ages. It will also test a new 12-month caregiver-led, home-based intervention designed to support child development.

How Is the Trial Designed?

Group I: Developmental Screening + Home-Based Intervention Experimental Treatment 1 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 II: Developmental Screening Active Control 1 Intervention

Participants in this group will complete developmental screening at 9, 18, and 30 months of age.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06562439

Testing the Sickle Cell Caregiver Collaboration for Child ... This pilot randomized controlled trial design is designed to (1) examine the potential effects of SCCCD on child development and caregiver well-being compared ...

2. reporter.nih.gov reporter.nih.gov/project-details/11097168

RePORT RePORTER - National Institutes of Health (NIH) | ... Sickle Cell Collaboration for Child Development (SCCCD) intervention. The SCCCD combines skilled therapeutic intervention to address developmental deficits ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5344022/

A Pilot Study of Parent Education Intervention Improves ... A Pilot Study of Parent Education Intervention Improves Early Childhood Development among Toddlers with Sickle Cell Disease · Abstract · Introduction · Methods.

4. parentsasteachers.org parentsasteachers.org/research-and-results/

Research and Results A pilot study of parent education intervention improves early childhood development among toddlers with sickle cell disease. Pediatr Blood Cancer, 63(12): ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-14-116

Development and feasibility of a home-based education ... Development and feasibility of a home-based education model for families of children with sickle cell disease. Catherine Hoyt Drazen,; Regina ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6026013/

Sickle cell disease and implementation science We discuss the role of implementation science in SCD and highlight the need for this science to shorten the length of time to implement evidence-based care for ...

7. ashpublications.org ashpublications.org/bloodadvances/article/8/23/6088/518045/Social-determinants-of-health-affect-disease

Social determinants of health affect disease severity among ... SDoH affects disease severity in children with SCD (aged 0-6 years) despite evidence-based therapy and health care facility support.

8. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper206015.html

Underutilization of Disease-Modifying Therapies in Sickle ... The ASH RC Sickle Cell Disease Data Hub is a real-world data resource incorporating electronic health records from 14 sites across the United States on patients ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0268960X25000438

Review Evidence and gaps in clinical outcomes of novel ... This systematic review aims to summarise the clinical outcomes of l-glutamine, crizanlizumab, and voxelotor in the treatment of sickle cell disease (SCD)