SUNRISE Cluster RCT: Scaling Up Nurturing Care, a Radio Intervention to Stimulate Early Child Development in Burkina Faso
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,875
- Locations
- 2
- Primary Endpoint
- Primary intermediate outcome: z-standardised observed sensitive responsiveness score using the National Institute of Child Health and Human Development (NICHD) sensitivity scales.
Study Overview
Brief Summary
SUNRISE aims to develop and evaluate a radio campaign to promote nurturing care behaviours in the first 3 years of life, particularly responsive parenting and providing opportunities for early learning. The campaign will be broadcast by local radio stations in Burkina Faso for 3 years and comprise: 60-second radio 'spots' including scripted dramas and modelling of responsive parent-child interactions, broadcast 10 times a day in weekly cycles; plus long format evening programs 2-3 times/week, incorporating longer dramas, real life testimonials and practical 'how to' advice, with space for listeners to call in, express opinions and ask questions. The campaign's impact on early child development (ECD) will be evaluated using a cluster RCT design, alongside a process and health economic evaluation.
Detailed Description
STUDY AIMS
SUNRISE aims to develop and evaluate, in a cluster randomised trial, a radio campaign in Burkina Faso, to promote nurturing care behaviours in the first 3 years of life, focusing particularly on responsive parenting and providing opportunities for early learning. Children's developmental outcomes will be assessed over the lifetime of the intervention until children are aged 30-32 months.
TRIAL CLUSTERS The trial clusters are defined by the broadcast reach of local radio stations. Eligible clusters for the trial were identified as follows. First 23 potential clusters in areas of Burkina Faso where there is no security risk were identified by modelling the reach and signal strength of local radio stations based on tower location, antenna characteristics, and terrain features. A media survey was then carried out to check the radio stations listened to in each of these clusters. This resulted in 15 clusters which satisfy the following conditions: there are at most two dominant radio stations within the cluster; there is no discernible broadcast from stations in neighbouring clusters; they are not based in the large cities of Ouagadougou or Bobo-Dioulassou; and they are not subject to any security risk.
MAPPING EVALUATION AREAS (EAs) Trial participants will be recruited from an evaluation area within each cluster that is close to the radio station(s), has a high signal strength confirmed by a motorbike survey and likely to have a high listenership based on the media survey. The following will be excluded from the area: towns, villages within 5 Km of towns, villages already on the national electricity grid and villages with populations of 5000 or more as they are likely to be a priority for the national electrification programme.
BASELINE SURVEY
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Although the nature of the intervention precludes formal masking of fieldworkers during data collection, we believe that this is unlikely to lead to bias for the following reasons: the data collection will be carried out completely independently of the campaign team; emphasis throughout training will be on understanding early child development, rather than on evaluating the radio campaign; the assessments will follow standardized data collection protocols; and the coders of the responsive parenting videos will be blind to their allocation status. In addition, the strict "blinding" procedures for data analysis described above have been designed to avoid any bias in methodological decisions or interpretation of findings all analyses will first be conducted blind to intervention allocation as. Finally, the randomisation was carried out and the code held by the independent trial statistician; it will only be shared with the campaign team.
Eligibility Criteria
- Ages
- 0 Months to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Live newborns with a birth date at least 3 months following the launch of the SUNRISE radio campaign will be eligible to be enrolled into the trial, together with their mothers.
Exclusion Criteria
- •Children with major infant congenital defects, children not living with their mother, and children with mothers who are not capable of participating in assessments.
- •For clarification:
- •Age limits are for age at recruitment; children will be followed until age 30-32m.
- •Early child development is the condition under study; this applies to all the participants. "Accepts Healthy Volunteers" is not meaningful in this trial.
Outcomes
Primary Outcomes
Primary intermediate outcome: z-standardised observed sensitive responsiveness score using the National Institute of Child Health and Human Development (NICHD) sensitivity scales.
Time Frame: Assessed when child is age 8-20 months
Sensitive responsiveness will be directly observed when the child is age 18-20m. Mothers will be video recorded carrying out a set of interactive tasks in which the child is introduced to a series of novel toys; this will last about 15 minutes. The videos will be independently coded, blind to whether the mother is in an intervention or control cluster, using the National Institute of Child Health and Human Development (NICHD) sensitivity scales, which assess "a parent's accuracy in perceiving and interpreting their infant's cues and their ability to react in a timely and appropriate manner".
Primary impact outcome: MDAT/GSED Child Development score
Time Frame: Assessed when child is age 30-32 months
The Malawi Developmental Assessment Tool (MDAT) is a well validated developmental assessment, that has been designed and adapted to be appropriate in low resource settings and for a wide range of cultures and contexts. It consists of 136 test items, with 34 items covering gross and fine motor development, language and social development. A total score will be computed as an overall index of child development. The tool shows excellent inter-rater reliability and good sensitivity and specificity for identifying children with developmental disability/delays. Note: During the early phases of this trial, we will evaluate the evidence regarding the Global Scales of Early Development - Long Form (GSED-LF), which has more items than the MDAT and is expected to be a more sensitive assessment. Field testing of the GSED is nearly complete at the time of writing. If a decision is taken to use the GSED-LF this will be ratified by the TSC and approved by the REC.
Secondary Outcomes
- Secondary impact outcome: Five 6-monthly caregiver reported language development scores(Assessed 6-monthly, starting when the child is age 6-8 months until age 30-32 months.)
- Secondary impact outcome: MDAT child development domain scores(Assessed when child is age 30-32 months)
- Secondary impact outcome: Five 6-monthly CREDI-LF total scores(Assessed 6-monthly, starting when the child is age 6-8 months until age 30-32 months.)
- Secondary intermediate outcome: The HOME-IT inventory (Home Observation for Measurement of the Environment, Infants & Toddler version) score(Assessed when the child is age 18-20 months.)
- Secondary intermediate outcome: Five 6-monthly Family Care Indicators (FCI) scores.(Assessed 6-monthly, starting when the child is age 6-8 months until age 30-32 months.)