Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06562439
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 31 Months
Healthy Volunteers
Not accepted

Interventions

  • Sickle Cell Collaboration for Child Development — 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Aug 2024
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • No Intervention: Developmental Screening
    Participants in this group will complete developmental screening at 9, 18, and 30 months of age.
  • Experimental: 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.

Primary Outcome Measure

Bayley Scales of Infant Toddler Development-IV [ Time Frame: Completed at 9, 18 and 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63108
Catherine R Hoyt, PhD
[email protected]
314-286-1761
Tiffany Radar
[email protected]
3142861197
Catherine R Hoyt, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Sickle cell disease
By research site
Washington University School of Medicine· St Louis, MO

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