Caregiver Program for Sickle Cell Disease

(SCCCD Trial)

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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Sickle Cell Collaboration for Child Development?

The research highlights the importance of involving caregivers and multiple stakeholders in improving care for children with sickle cell disease, suggesting that collaborative approaches can enhance preventive care and address barriers in treatment delivery. Additionally, providing psychosocial support to caregivers can improve their wellbeing, which may positively impact the care they provide to children with sickle cell disease. ^{1 2 3 4 5}

How does the Caregiver Program for Sickle Cell Disease differ from other treatments for sickle cell disease?

The Caregiver Program for Sickle Cell Disease is unique because it focuses on providing psychosocial support to caregivers, helping them manage stress and improve their wellbeing, which in turn can enhance the quality of care for children with sickle cell disease. Unlike traditional treatments that target the physical symptoms of the disease, this program addresses the emotional and lifestyle challenges faced by caregivers. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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 child has fragile health

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Setting the agenda for quality improvement in pediatric sickle cell disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Designing a Multistakeholder Collaboration to Improve Preventive Care for Children With Sickle Cell Anemia. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Parent Perspectives on Pain Management in Preschool-Age Children With Sickle Cell Disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Emotional distress among parent caregivers of adolescents with sickle cell disease: Association with patients and caregivers variables. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Biopsychosocial Factors Associated with Parenting Stress in Pediatric Sickle Cell Disease. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Developmental screening in young children with sickle cell disease. Results of a cooperative study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Caregiving time in sickle cell disease: psychological effects in maternal caregivers. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Developmental delay in infants and toddlers with sickle cell disease: a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Child-rearing practices of primary caregivers of children with sickle cell disease: the perspective of professionals and caregivers. [2019]