Child DevelopmentNCT03847675
Reach Out and Read Arabic to Promote Arabic Literacy in Toddlers
A study testing Reach out and Read in people with Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Reach out and Read
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2018to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Reach Out and Read" Arabic to Promote Parental Reading to Toddlers and Preschoolers
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.
Read the detailed description
Early reading for toddlers has been linked to a better grasp of the fundamentals of language as they approach school age, as reading exposes the child to rich language and diverse content. Reach Out and Read program (ROR) is an American non-profit organization that advocates for childhood literacy.
In this study the investigators aim to implement an adapted version of the "Reach Out and Read" program and to encourage parents to read Arabic books to their children in order for this to become a daily habit. The goal of this study is to see an increase in the proportion of parents who read Arabic books to their children and by extension children will grow up loving to read Arabic books and ultimately may have improved Arabic literacy.
- Conditions
- Child Development
- Being tested
- Reach out and Read
- Keywords
- Reach out and Read, Arabic literacy, Child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach out and ReadBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
Weekly frequency of parental reading in Arabic before, and after the intervention
The weekly frequency of parental reading in Arabic before, and after the intervention at each age group (9, 12 and 15 months), then at 2 and 3 years of age as compared between experimental and control group
Measured: 3 years
Children's vocabulary and language / words'
The children's vocabulary and language / words' acquisition in the experimental compared to the control group at 2 years and 3 years.
Measured: 3 years
Children's early developmental milestones
The children's early developmental milestones in the experimental compared to the control group at 2 years and 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Nov 2018
- Primary completion30 May 2022
- Study completion30 Jul 2022
Why it stopped: Poor recruitment and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
- Investigators
- Lama Charafeddine, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847675
- Sponsor's protocol ID
- PED.LC.13
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18477693Kuhl 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.
PubMed 21892359
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Reach Out and Read" Arabic to Promote Parental Reading to Toddlers and Preschoolers
- ClinicalTrials.gov ID
- NCT03847675
- Acronym / sponsor ID
- PED.LC.13
- Conditions
- Child Development
- Keywords
- Reach out and Read, Arabic literacy, Child development
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment and lack of funding
- Enrolment
- 20 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early reading for toddlers has been linked to a better grasp of the fundamentals of language as they approach school age, as reading exposes the child to rich language and diverse content. Reach Out and Read program (ROR) is an American non-profit organization that advocates for childhood literacy.
In this study the investigators aim to implement an adapted version of the "Reach Out and Read" program and to encourage parents to read Arabic books to their children in order for this to become a daily habit. The goal of this study is to see an increase in the proportion of parents who read Arabic books to their children and by extension children will grow up loving to read Arabic books and ultimately may have improved Arabic literacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Reach out and ReadThe 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 |
| 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 |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach out and ReadThe 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. | Behavioural | Intervention |
Primary outcome
Proportion of parents reading Arabic books to their children
Time frame: 3 years
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 secondary outcomes
Weekly frequency of parental reading in Arabic before, and after the intervention
Time frame: 3 years
Children's vocabulary and language / words'
Time frame: 3 years
Children's early developmental milestones
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Poor recruitment and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 18477693Duursma 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.
- Background: PubMed 21892359Kuhl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama Charafeddine, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach out and Read in people with Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of parents reading Arabic books to their children (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03847675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.