Assuring Patient-centered Literacy Promotion for Underserved Children Study

Study Overview
=================
Brief Summary
-----------------
This study tests whether an enhanced primary cared based literacy promotion intervention consisting of a video and text message will increase shared reading occurrences between parents and children compared to the standard version.

Detailed Description
-----------------
This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced intervention consisting of a video and a series of text messages in promoting shared reading between parents and children. Participants will be randomized to one of two study arms (1) the enhanced intervention consisting of a video in the waiting room, standard guidance on shared reading, and a series of text messages (2) regular care which includes standard guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary outcomes will include receipt of intervention, measure of the cognitive home environment, developmental screening results, and measure of parent reading beliefs.

Official Title
-----------------
Assuring Patient-centered Literacy Promotion for Underserved Children to Promote School Readiness

Conditions
-----------------
Literacy

Intervention / Treatment
-----------------
* Behavioral: Intervention Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary caregiver of a child age 6-15 months, primary language English or Spanish, cell phone ownership, age ≥18 years, willing to receive text messages, and willing to accept randomization Exclusion Criteria: Individuals unable to provide consent Individuals who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular care group<br>This group will receive regular care including standard guidance on shared reading. Participants in this arm will not view the video at the time of enrollment nor will they receive the text messages throughout the 6 months of the randomized controlled trial. | |
| Experimental: Intervention group<br> | Behavioral: Intervention Group<br>* This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading Recall | Parents will report reading occurrences in a 1 week period including a 24-hour recall. | Visit 2 (approx. 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey of Wellbeing of Young Children Milestones | Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool. | Visit 2 (approx. 6 months) | 
| StimQ2 Read Scale / Parental Verbal Responsivity Scale | The StimQ2 is a parent reported measure of the cognitive home environment for children age 5 months to 6 years that assesses 4 domains: (1) Availability of Learning Materials (2) Reading (3) Parent Involvement in Developmental Advancement (4) Parental Verbal Responsiveness. | Visit 2 (approx. 6 months) | 
| Parental Reading Beliefs Inventory | Measure of parent reading beliefs | Visit 2 (approx. 6 months) | 
| Receipt of intervention | Parent report of receipt of guidance on shared reading | Visit 2 (approx. 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reading, Text Messages, Video, Cognitive Development, Child Development, Infants