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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: ISRCTN
Last refreshed on: 6 January 2020
Main ID:  ISRCTN67389010
Date of registration: 12/03/2018
Prospective Registration: No
Primary sponsor: Effective Intervention
Public title: Raising outcomes in primary education, a cluster randomised trial in rural Guinea Bissau
Scientific title: ROPE: Raising Outcomes in Primary Education, a cluster randomised trial to improve reading and mathematics skills of children entering primary education with hired and trained teachers in south of rural Guinea Bissau
Date of first enrolment: 01/12/2012
Target sample size: 2100
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN67389010
Study type:  Interventional
Study design:  Unblinded stratified cluster randomized trial (Other)  
Phase:  Not Applicable
Countries of recruitment
Guinea-Bissau
Contacts
Name: Peter    Boone
Address:  Effective Intervention 66 Crouch Hal Road N8 8HA London United Kingdom
Telephone:
Email:
Affiliation: 
Name: Ila    Fazzio
Address:  Effective Intervention NGO 66 Crouch Hal Road N8 8HA London United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Participating clusters were selected from a list with all villages in these districts trying to maximise the number of children enrolled as far as these villages had less than 400 households and were more than 9 km apart (to avoid contamination). They are a representative sample of the villages accessible by land with total households between 44 and 256 (approximately 270 to 1500 inhabitants).

A child is considered eligible for the trial if s/he satisfies the following criteria:
1. S/he was born between January 2007 and September 2008
2. S/he is resident in eligible villages
3. S/he does not have serious conditions that may impair learning
4. Parents give the consent to participate in the study

Exclusion criteria: Children who were not resident in the trial villages or outside of the age group

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Primary education
Not Applicable
Primary education
Intervention(s)

For randomisation a cluster analysis was conducted to group the villages into homogeneous strata regarding the following variables: village’s distance to road, highest grade taught by the school if the village had a school (the grade was zero if the village did not have a school), number of households in the village, proportion of mothers speaking Crioulo in the village, and third quartile of mothers education in the village. These variables were selected on the assumption that they are correlated with the primary outcome, as showed by the NBER education study (Boone et al. 2013). The results of the cluster analysis suggested that two strata were sufficient, one with 17 villages, another one with 32. The cluster analysis was conducted in SAS Software version 9.3, using PROC CLUSTER.

The villages were randomised to intervention or control within each of the two strata formed, using an algorithm developed with SAS Software version 9.3. There are 49 participating villages grouped in two strata, 17 in stratum 1 and 32 in stratum 2. There was a fixed number of 26 teachers who were allocated to strata proportionally to the strata sizes: 26 x 17/49=9 to stratum 1 and 26 x 32/49=17 to stratum 2. The algorithm selects villages at random without replacement, within each stratum, until reaching the fixed number of teachers assigned to that stratum. The allocation ratio for intervention and control villages were not 1:1, but determined by randomisation, between 1:1 and 1:2.

The intervention programme comprises high quality and extensive in-service teacher training with monitoring, teaching and academic support, the development and distribution of pedagogical teaching and learning materials for teacher and children from propaedeutic to 3rd grade. Children in the intervention arm are offered high quality teaching during the normal school hours. The teaching group was intensively and rigorously trained before and during the trial
Primary Outcome(s)
Combined test scores of the mathematics (EGMA) and reading (EGRA) tests conducted in all participant villages between the 28 November and 16 December 2017 (about 44 months after the intervention had started). Child-specific composite test scores extracted from tests will be analysed using a generalised linear model to account for clustering and stratification, comparing intervention vs. control using (adjusted) differences between mean scores. For the primary comparison an intervention-gender interaction will be tested. The primary analysis will follow the intention to treat principle (i.e. the participants will remain in the group they were randomised to and not analysed according to the interventions actually received).
Secondary Outcome(s)

1. Reading is measured using scores at Early Grade Reading Assessment (EGRA) in Nov/Dec 2017
2. Mathematics is measured using scores at Early Grade Mathematics Assessment (EGMA) test in Nov/Dec 2017
3. School enrolment measured biennially by visiting all enumerated households and interviewing parents using the questionnaire of Annual School Enrolment in Jan/Feb 2015 and Jan/Feb 2017
4. Reported attendance measured biennially by visiting all enumerated households and interviewing parents using the questionnaire of Annual School Enrolment in Jan/Feb 2015 and Jan/Feb 2017
5. Costs are calculated per child between Feb 2013 and Dec 2017
Secondary ID(s)
Source(s) of Monetary Support
Effective Intervention
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
1. London School of Economics, self-assessment in social sciences procedures, 09/02/2018 2. Ministry of Education in Guinea-Bissau, 30/08/2012 3. NBER ethics committee, 01/07/2014, ref: IRB Ref#14_060
Results
Results available:
Date Posted:
Date Completed: 20/12/2017
URL:
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