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

August 21, 2024 updated by: Washington University School of Medicine

Early Identification and Intervention Of Developmental Delay Among Infants And Toddlers With Sickle Cell Disease Using the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Catherine R Hoyt, PhD
  • Phone Number: 314-286-1761
  • Email: hoytcr@wustl.edu

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine R Hoyt, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Toddler Activity Card Sort
Time Frame: 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.
Completed at 9, 18 and 30 months
Bayley Scales of Infant Toddler Development-IV
Time Frame: 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. Scaled scores range from 1-19, where a score of 10 is average and a higher score indicates better outcome.
Completed at 9, 18 and 30 months
Ages and Stages Questionnaire-3
Time Frame: 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.
Completed at 9, 18 and 30 months
Behavior Rating Inventory of Executive Function-Preschool
Time Frame: 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.
30 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 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.
through study completion, an average of 1 year
Fidelity
Time Frame: 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.
through study completion, an average of 1 year
PROMIS Depression (Caregiver)
Time Frame: 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.
Completed at child's 9, 18 and 30 month evaluation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCCD.SRP.OT
  • K23HL161328 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Findings from this proposal will be disseminated in peer-reviewed publications and at scholarly meetings following best practices guidelines (e.g., Equator network guidelines).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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