- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04027257
Sit Together and Read (STAR): A Pilot Study of Children and Their Kinship Caregivers (STAR-K)
Sit Together and Read (STAR) to Improve Reading Skills for Children and Parenting Self-Efficacy for Caregivers: A Pilot Study of Children Affected by Parental Opioid Use and Their Kinship Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parental substance use is the second leading cause of foster care placement, with nearly 50% of cases involving children under age five years. Fifty percent of all Ohio children taken into child protective services experienced parental drug use, with rates higher than 75% in some Ohio counties. Approximately 100,000 Ohio grandparents and relatives are providing kinship care for children affected by parental drug use.
STAR is an evidence-based home-based shared book reading intervention designed to improve the foundational reading skills of preschoolers who are at risk for reading disabilities. The potential for STAR to positively impact the kinship family is multi-faceted. STAR was developed to accelerate the early reading development of vulnerable children, including those in kinship care. The investigators expect STAR to promote positive caregiver-child interactions and improve kinship caregivers' sense of self-efficacy with respect to supporting the child's reading development. The implementation of the STAR intervention is innovative because it will provide tangible and important financial and material resources that have been effective in improving short- and long-term academic outcomes for children living in low SES environments that may not otherwise be available to kinship families.
The overarching goal is to examine the feasibility and effectiveness of an evidence-based reading intervention in a group of kinship caregivers and children affected by parental opioid use. In this pilot implementation, investigators will enroll up to 50 kinship caregivers and the 4 to 5 year old children in their care to determine the feasibility of the STAR intervention in this population (Aim 1). The investigators will determine the extent to which STAR imparts positive and significant effects on children's foundational reading skills (Aim 2). The investigators will examine the extent to which participation in STAR, and the associated training and supports provided, are associated with positive changes in kinship caregivers' self-efficacy with respect to supporting the reading development of the children in their care (Aim 3). Investigators will meet the objectives of this work by using a randomized (1:1) waitlist controlled trial design. The randomization scheme will be prepared prior to any participant enrollment by a statistician not affiliated with the project. Successful implementation of this work will provide financial and material resources to families in need, while simultaneously engaging kinship families in an evidenced-based intervention that is proven effective at improving young children's reading trajectories.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Dublin, Ohio, United States, 43201
- Email List Servs
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child 4 years, 0 months to 5 years, 11 months at enrollment
- Child in kinship care
- Child experienced parental opioid use prior to kinship care
- Kinship caregiver willing to attend in-person meetings
- Kinship caregiver willing to read regularly to the child in English for 15 consecutive weeks
Exclusion Criteria:
- NA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STAR
Receive 15-week STAR intervention immediately after pretest.
|
STAR is an evidence-based home-based shared book reading intervention designed to improve the foundational reading skills of preschoolers who are at risk for reading disabilities.
|
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No Intervention: Waitlist Control
No intervention for the 15 weeks after pretest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
STAR Log
Time Frame: 15-week intervention period
|
Document intensity, defined as occurrence and length of each session and targeted goals within each.
|
15-week intervention period
|
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STAR Fidelity Coding Checklist (FCC)
Time Frame: 15-week intervention period
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Document dosage, defined as the volume of explicit targeting of print-related objectives during STAR sessions.
|
15-week intervention period
|
|
Preschool Word and Print Awareness (PWPA)
Time Frame: 15-week intervention period
|
Examines knowledge of 15 print concepts.
Scores on this scale range from 0-17, with higher scores indicative of better performance.
|
15-week intervention period
|
|
Phonological Awareness Literacy Screening-PreK (PALS-PreK)
Time Frame: 15-week intervention period
|
Upper and Lower Case Letter Knowledge subtests will identify the number of letters children can name.
The range on these subtests is 0-26, with higher scores indicative of better performance.
The name writing subtest will assess children's ability to write their own name.
The range on this subtest is 0-7, with higher scores indicative of better performance.
|
15-week intervention period
|
|
Test of Preschool Emergent Literacy (TOPEL)
Time Frame: 15-week intervention period
|
The print knowledge subtest will be used to assess children's skills on a variety of print-related tasks, such as distinguishing print from other visual stimuli and identifying alphabet letters.
Raw scores on this subtest range from 0-36, with higher scores indicative of better performance
|
15-week intervention period
|
|
Parenting Sense of Competence Scale
Time Frame: 15-week intervention period
|
Assesses kinship caregivers' self-efficacy.
Scores on this measure range from 17-102, with higher scores representing a higher parenting sense of competency.
|
15-week intervention period
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019B0129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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