Sit Together and Read (STAR): A Pilot Study of Children and Their Kinship Caregivers

NCT04027257 | Completed

• 1 other identifier: 2019B0129
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Parental substance use is the second leading cause of foster care placement. As a result, nearly 100,000 Ohio grandparents, family, friends, and neighbors are providing kinship care for children. Kinship caregivers are more likely to be of lower socioeconomic status, report less warmth and respect in their parenting attitudes, and exhibit higher levels of caregiver-child conflict, relative to traditional foster parents. These characteristics, in addition to the trauma associated with exposure to parental drug use, contribute to a significant risk for reading difficulties and lower overall academic achievement for affected children. The objective is to pilot an evidence-based reading intervention in a group of kinship caregivers and children affected by parental opioid use. This work is significant because the investigators aim to improve reading outcomes of children who may otherwise experience substantial difficulty with reading development, and to support kinship caregivers who may otherwise have few resources to promote the reading skills of children placed in their care. The approach will use a randomized (1:1) waitlist controlled trial design to examine the effects of a 15-week kinship caregiver-implemented Sit Together and Read (STAR) intervention for 4-5 year old children being raised by kin as a result of parental opioid use.

Conditions

Reading

Outcome Measures

Primary Outcomes (6)

• STAR Log

  Document intensity, defined as occurrence and length of each session and targeted goals within each.

  15-week intervention period

• STAR Fidelity Coding Checklist (FCC)

  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)

  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)

  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)

  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

  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

Study Arms (2)

STAR

EXPERIMENTAL

Receive 15-week STAR intervention immediately after pretest.

Behavioral: Sit Together and Read (STAR)

Waitlist Control

NO INTERVENTION

No intervention for the 15 weeks after pretest.

Interventions

Sit Together and Read (STAR) BEHAVIORAL

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.

STAR

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Sherine Tambyraja: lead
• Ohio State University: collaborator

Study Sites (1)

Email List Servs

Dublin, Ohio, 43201, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Specialist

Model Details: Participants will be randomized to start the intervention immediately after baseline assessment (i.e., treatment) or approximately 15 weeks later after the baseline assessment (i.e., waitlist control).

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 19, 2019
• Study Start: October 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)