Promoting Caregiver Implementation of an Effective Early Learning Intervention

The Ohio State University

Status: Enrolling

Conditions: Developmental Language Disorder; Reading; Difficult

Treatments: Behavioral: Text Encouragement; Behavioral: Monetary Reward; Other: Sit Together and Read (STAR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06275815

R01DC020958

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 48 to 71 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 4 patient groups

Untreated Control

No Intervention group

Description:

Caregivers read to child as usual over 15 week period.

STAR Only

Experimental group

Description:

Typical implementation of Sit Together and Read (STAR)

Treatment:

Other: Sit Together and Read (STAR)

STAR + Reward

Experimental group

Description:

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

Treatment:

Other: Sit Together and Read (STAR)

Behavioral: Monetary Reward

STAR + text encouragement

Experimental group

Description:

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

Treatment:

Other: Sit Together and Read (STAR)

Behavioral: Text Encouragement