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Completed

NCT Number: NCT04027257

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

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.

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Key information

Conditions

Reading

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Email List Servs

Dublin, Ohio, 43201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. STAR Log

    Time frame: 15-week intervention period

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

  2. STAR Fidelity Coding Checklist (FCC)

    Time frame: 15-week intervention period

    Document dosage, defined as the volume of explicit targeting of print-related objectives during STAR sessions.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Sherine Tambyraja

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Acronym: STAR-K

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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