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

Not Applicable

Not yet recruiting

• Conditions: Sickle Cell Disease
• Interventions: Behavioral: Sickle Cell Collaboration for Child Development

• Registration Number: NCT06562439
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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 ...

Detailed Description

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 evalu...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-20
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Study Start: 2025-01-01
• Primary Completion: 2028-01-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Developmental Screening + Home-Based Intervention	Sickle Cell Collaboration for Child Development	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 Measures

Name	Time	Method
Bayley Scales of Infant Toddler Development-IV	Completed at 9, 18 and 30 months	Child participants will complete up to 3 developmental evaluations with a trained evaluator using the Bayley Scales of Infant Toddler Development-IV. The Bayley assesses development in the domains of cognition, fine and gross motor, and expressive and receptive language. Caregiver questionnaires assess adaptive behavior and social emotional development. Scal...
Ages and Stages Questionnaire-3	Completed at 9, 18 and 30 months	Caregivers will complete the Ages and Stages Questionnaire-3, which assesses the caregivers perspective of how their child is meeting developmental milestones in the domains of communication, gross motor, fine motor, personal-social and problem solving. Scores range from 0-60, where a higher score indicates a better outcome.
Behavior Rating Inventory of Executive Function-Preschool	30 months of age	The Behavior Rating Inventory of Executive Function-Preschool (BRIEF) evaluates executive functioning of toddlers \>2.5 years. Executive functioning is identified as a high risk domain for deficits among individuals with sickle cell disease. Raw scores are converted to t-scores (mean = 50, SD = 10) and scores above 65 are considered clinically significant.
Infant Toddler Activity Card Sort	Completed at 9, 18 and 30 months	Caregivers will complete the Infant Toddler Activity Card Sort (ITACS) to determine activities and routines that are presenting performance or participation challenges for families in the context of their everyday lives.

Secondary Outcome Measures

Name	Time	Method
Fidelity	through study completion, an average of 1 year	The Comprehensive Intervention Fidelity Guide will be used to evaluate intervention design, training and delivery. This guide specifies the intervention model, the fidelity indices (e.g., participation and retention rates) and compare those to outcome measures.
PROMIS Depression (Caregiver)	Completed at child's 9, 18 and 30 month evaluation.	The Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression short form is a valid and reliable 8-item tool to screen for depression. Scores range from 8-40, with higher scores indicating more severe depression symptoms.
Acceptability	through study completion, an average of 1 year	Study visit completion rates and notes from intervention visits will be reviewed. Interviews will be conducted with all participants in the SCCCD intervention, regardless of completion to determine components that contributed to participation or attrition.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States