Promoting Caregiver Implementation of an Effective Early Learning Intervention

NCT ID: NCT06275815

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2028-07-31

Brief Summary

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The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:

* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.

Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.

Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions.

Detailed Description

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Conditions

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Developmental Language Disorder Reading; Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Untreated Control

Caregivers read to child as usual over 15 week period.

Group Type NO_INTERVENTION

No interventions assigned to this group

STAR Only

Typical implementation of Sit Together and Read (STAR)

Group Type EXPERIMENTAL

Sit Together and Read (STAR)

Intervention Type OTHER

Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.

STAR + Reward

Typical implementation of Sit Together and Read (STAR) plus additional small monetary incentives for caregivers

Group Type EXPERIMENTAL

Sit Together and Read (STAR)

Intervention Type OTHER

Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.

Monetary Reward

Intervention Type BEHAVIORAL

Caregiver receives a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings).

STAR + text encouragement

Typical implementation of Sit Together and Read (STAR) plus caregivers receive encouraging text messages

Group Type EXPERIMENTAL

Sit Together and Read (STAR)

Intervention Type OTHER

Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.

Text Encouragement

Intervention Type BEHAVIORAL

Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.

Interventions

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Sit Together and Read (STAR)

Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.

Intervention Type OTHER

Monetary Reward

Caregiver receives a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings).

Intervention Type BEHAVIORAL

Text Encouragement

Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.

Intervention Type BEHAVIORAL

Other Intervention Names

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STAR Read-Aloud Practices Read-Aloud Practices SMS Messaging

Eligibility Criteria

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Inclusion Criteria

* receiving or on waitlist for speech services
* primary complaint of impaired language skills
* receptive, expressive, or mixed language disorder
* primarily communicates in English

Exclusion Criteria

1. No known additional diagnoses causal of developmental language disorder including

1. autism spectrum disorder
2. hearing loss
3. severe intellectual disability
2. Is not attending or has completed Kindergarten
Minimum Eligible Age

48 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura M Justice, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy

Columbus, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer M Bostic, MA

Role: CONTACT

614-292-5715

Laura M Justice, PhD

Role: CONTACT

614-292-1045

Facility Contacts

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Jennifer M Bostic, MA

Role: primary

614-292-5715

Jamie B Boster, PhD

Role: primary

614-722-8756

Other Identifiers

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R01DC020958

Identifier Type: NIH

Identifier Source: org_study_id

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