Condition or disease | Intervention/treatment | Phase |
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Reading | Behavioral: Sit Together and Read (STAR) | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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). |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | May 31, 2021 |
Arm | Intervention/treatment |
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Experimental: STAR
Receive 15-week STAR intervention immediately after pretest.
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Behavioral: Sit Together and Read (STAR)
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.
|
No Intervention: Waitlist Control
No intervention for the 15 weeks after pretest.
|
Ages Eligible for Study: | 4 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sherine Tambyraja | 3474157615 ext 3474157615 | tambyraja.1@osu.edu |
United States, Ohio | |
Email List Servs | Recruiting |
Dublin, Ohio, United States, 43201 | |
Contact: Sherine Tambyraja 347-415-7615 ext 3474157615 tambyraja.1@osu.edu |
Tracking Information | |||||
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First Submitted Date ICMJE | June 28, 2019 | ||||
First Posted Date ICMJE | July 19, 2019 | ||||
Last Update Posted Date | September 16, 2020 | ||||
Actual Study Start Date ICMJE | October 1, 2019 | ||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sit Together and Read (STAR): A Pilot Study of Children and Their Kinship Caregivers | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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). Masking: None (Open Label)Primary Purpose: Prevention |
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Condition ICMJE | Reading | ||||
Intervention ICMJE | Behavioral: Sit Together and Read (STAR)
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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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 31, 2021 | ||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years to 6 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04027257 | ||||
Other Study ID Numbers ICMJE | 2019B0129 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sherine Tambyraja, Ohio State University | ||||
Study Sponsor ICMJE | Sherine Tambyraja | ||||
Collaborators ICMJE | Ohio State University | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Ohio State University | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |