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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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6 January 2020 |
Main ID: |
ISRCTN68855267 |
Date of registration:
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22/01/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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EMERGE Reading Pilot Study: Adaptation and scaling of early reading interventions in Kenya (Phase 1)
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Scientific title:
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EMERGE Reading Pilot Study: Adaptation and scaling of early reading interventions in Kenya to improve early childhood development (Phase 1) |
Date of first enrolment:
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27/01/2016 |
Target sample size:
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1250 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN68855267 |
Study type:
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Interventional |
Study design:
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Multi-arm clustered randomized control trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Owen
Ozier |
Address:
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The World Bank
1818 H St NW
Mail Stop MC3-311
20433
Washington DC
United States of America |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children aged between 2 to 6 years old and their primary care giver 2. Living within 1km of a small primary school (<20 children per class) in Nyanza province
Exclusion criteria: Developmental delays or health conditions that would interfere with a child’s ability to take a standard developmental assessment or participate in the intervention (i.e. blindness and deafness).
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Poor early development of cognition and language in children Not Applicable Poor early development of cognition and language in children
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Intervention(s)
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The intervention has 5 study arms, with increasing levels of intensity of the intervention. Households in the same primary school catchment areas are randomly assigned to one of the 5 study arms using the Stata software package.
Group 1: Participants in this arm do not receive the intervention (comparator arm) Group 2: Participants receive a set of children's storybooks in English, Luo and Swahili Group 3: Participants receive the same intervention as group 2, in addition to a parent training on dialogic reading skills, and SMS reminders to keep parents engaged with the books (added 23/02/2016) Group 4: Participants receive the same intervention as group 3, in addition to a booster training to keep parents engaged with the books and aware of strategies for reading and exploring the books with their children (added 23/02/2016) Group 5: Participants receive the same intervention as group 4, in addition to home visits to encourage parents and to address individual parent's questions, and allow for practice and feedback
Participants in all groups are followed up after 5 weeks. After data is collected to determine short-run impacts, the remaining eligible households who have not received an intervention will receive the same books as all others.
Previous: Group 3: Participants receive the same intervention as group 2, in addition to a parent training on dialogic reading skills Group 4: Participants receive the same intervention as group 3, in addition to a booster training and SMS reminders to keep parents engaged with the and aware of strategies for reading and exploring the books with their children
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Primary Outcome(s)
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1. The number of books in the home is measured by an enumerator's observation in the home at 5 weeks 2. Frequency of book use is measured by survey at baseline and endline (5 weeks) 3. Expressive and receptive vocabulary are measured by assessing children using adaptations of the British Picture Vocabulary Scale and purpose-specific illustrations at baseline and endline (5 weeks)
Added 27/04/2016: 4. Comprehension is measured by questions specific to storybook content at endline (5 weeks)
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Secondary Outcome(s)
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1. Home stimulation practices are measured by a Mother-Child observation conducted by an enumerator at baseline and endline (5 weeks) 2. Program take-up by intervention delivery method and sub-population include primary outcome measures, but with sub-populations divided according to baseline characteristics, including direct assessments of caregiver literacy based on reading a sentence in each of three languages. This will be assessed at endline (5 weeks)
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Source(s) of Monetary Support
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World Bank Group
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Ethics review
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Status:
Approval date:
Contact:
1. University of California, Berkeley Institutional Review Board, 27/05/2015, ref: 2014-09-6699
2. Human Subjects Committee for Innovations for Poverty Action, 03/12/2015, ref: 5691
3. Maseno University Ethics Review Committee, 03/11/2014, ref: 00118/14
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/12/2016 |
URL:
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