NCT03847675

Brief Summary

The goal of this study is to encourage parents to read Arabic books to their children from an early age and by extension children will be more likely to read Arabic books and ultimately improve their Arabic literacy. The investigators' hypothesis is that an adapted "Reach Out and Read" program will result in an increase in the proportion of parents reading Arabic books to their children after the intervention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

January 24, 2019

Last Update Submit

February 7, 2023

Conditions

Keywords

Reach out and ReadArabic literacyChild development

Outcome Measures

Primary Outcomes (1)

  • Proportion of parents reading Arabic books to their children

    Measure the proportion of parents reading Arabic books to their children after 3 intervention visits, when their child is about 15 months of age. Parental reading is defined as reading for a minimum of 10 minutes daily for at least 5 days per week.

    3 years

Secondary Outcomes (3)

  • Weekly frequency of parental reading in Arabic before, and after the intervention

    3 years

  • Children's vocabulary and language / words'

    3 years

  • Children's early developmental milestones

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

The research assistant introduces the adapted 'Reach out and Read" program and informs participants about the benefits of reading to children at an early age. A 4:50 minutes video clip would be shown during the initial visit. This video discusses the benefits of reading displaying practical tips for parents; it includes tips on how to read, pointing at the words. A schematic pamphlet highlighting the importance of reading Arabic to children and the impact of such reading on children's brain development, vocabulary acquisition and behavior in addition to the impact on the parent child bond and relationship is given to the parents. After each visit participants will receive an age appropriate book for their child. Focus groups will be conducted by a qualitative researcher

Behavioral: Reach out and Read

Control

NO INTERVENTION

The research assistant gives routine advice on child development including importance of reading and advice on nutrition and safety and gives parents a leaflet about early child development and complementary feeding

Interventions

The intervention group will be viewing a video encouraging to read to their children and giving tips on reading methods, in addition will be given a schematic pamphlet highlighting the importance of reading Arabic to children. After each visit participants will receive an age appropriate book for their child (a total of 3 books). The first book consist of popular nursery rhymes that are usually sung for younger infants. The choice of the 2 other books is based on recommendations from an early child educator according to age specificity. Focus group conducted by a qualitative researcher will follow the protocol reported by Richard A. Krueger.

Intervention

Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents must identify the study's settings as the usual site for their child regular checkups
  • Families are eligible if at least one parent understands, speaks and reads Arabic.
  • The child's age between 4 and 6 months at the time of the enrollment

You may not qualify if:

  • Children diagnosed or displaying severe behavioral, cognitive, or physical impairment, that prevents them in meaningfully engaging in a reading activity example: severe autism, profound developmental or intellectual delay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

Related Publications (2)

  • Duursma E, Augustyn M, Zuckerman B. Reading aloud to children: the evidence. Arch Dis Child. 2008 Jul;93(7):554-7. doi: 10.1136/adc.2006.106336. Epub 2008 May 13. No abstract available.

    PMID: 18477693BACKGROUND
  • Kuhl PK. Early Language Learning and Literacy: Neuroscience Implications for Education. Mind Brain Educ. 2011 Sep;5(3):128-142. doi: 10.1111/j.1751-228X.2011.01121.x.

    PMID: 21892359BACKGROUND

Study Officials

  • Lama Charafeddine, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: An experimental double blinded parallel arms randomized controlled trial with pre and post-intervention assessment over a period of 12 months with a follow up plan at 2 and 3 years of age
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Neonatology

Study Record Dates

First Submitted

January 24, 2019

First Posted

February 20, 2019

Study Start

November 1, 2018

Primary Completion

May 30, 2022

Study Completion

July 30, 2022

Last Updated

February 8, 2023

Record last verified: 2022-02

Locations