SUNRISE CRT: Radio Intervention to Stimulate Early Child Development

NCT05335395 | Unknown DMC

• 1 other identifier: EPPHZS42
• Study Type: interventional
• Target: 1,875
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Outcome Measures

Primary Outcomes (2)

• Primary impact outcome: MDAT/GSED Child Development score

  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.

  Assessed when child is age 30-32 months

• Primary intermediate outcome: z-standardised observed sensitive responsiveness score using the National Institute of Child Health and Human Development (NICHD) sensitivity scales.

  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".

  Assessed when child is age 8-20 months

Secondary Outcomes (5)

• 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 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 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.

Other Outcomes (1)

• Tertiary outcome: Two Caregiver ECD Knowledge Scores

  Assessed when the child is age 18-20 months and 30-32 months

Study Arms (2)

SUNRISE clusters

EXPERIMENTAL

SUNRISE campaign broadcast through local radio stations plus broadcasting as usual

Behavioral: SUNRISE radio campaign

Control clusters

NO INTERVENTION

Local radio stations broadcast as usual

Interventions

SUNRISE radio campaign BEHAVIORAL

The SUNRISE radio campaign will be promoting responsive caregiving and providing opportunities for early learning to support child development during the first 3 years of life. The SUNRISE campaign will follow DMI's established intervention approach with: 1. 60-second radio spots, tailored to increase awareness, knowledge, motivation, skills and opportunity regarding the target behaviours, will include scripted dramas and modelling of responsive parent-child interactions. Each spot will be broadcast 10 times a day for a week; the content of the spots will be changed on a weekly basis. This weekly cycle will continue for three years. 2. Long format 60-minute programmes broadcast 2-3 times a week, incorporating longer dramas, real life testimonials and practical 'how to' advice, with space for listeners to call in, express opinions and uncertainties and ask questions.

SUNRISE clusters

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Wellcome Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Development Media International: collaborator
• University College, London: collaborator
• Innovations for Poverty Action: collaborator

Study Sites (1)

Innovations for Poverty Action

Ouagadougou, Kadiogo, 01 BP 492, Burkina Faso

Location

Related Publications (7)

• Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

  PMID: 27717614 BACKGROUND

• Richter LM, Daelmans B, Lombardi J, Heymann J, Boo FL, Behrman JR, Lu C, Lucas JE, Perez-Escamilla R, Dua T, Bhutta ZA, Stenberg K, Gertler P, Darmstadt GL; Paper 3 Working Group and the Lancet Early Childhood Development Series Steering Committee. Investing in the foundation of sustainable development: pathways to scale up for early childhood development. Lancet. 2017 Jan 7;389(10064):103-118. doi: 10.1016/S0140-6736(16)31698-1. Epub 2016 Oct 4.

  PMID: 27717610 BACKGROUND

• McCoy DC, Sudfeld CR, Bellinger DC, Muhihi A, Ashery G, Weary TE, Fawzi W, Fink G. Development and validation of an early childhood development scale for use in low-resourced settings. Popul Health Metr. 2017 Feb 9;15(1):3. doi: 10.1186/s12963-017-0122-8.

  PMID: 28183307 BACKGROUND

• Kariger P, Frongillo EA, Engle P, Britto PM, Sywulka SM, Menon P. Indicators of family care for development for use in multicountry surveys. J Health Popul Nutr. 2012 Dec;30(4):472-86. doi: 10.3329/jhpn.v30i4.13417.

  PMID: 23304914 BACKGROUND

• Gladstone M, Lancaster GA, Umar E, Nyirenda M, Kayira E, van den Broek NR, Smyth RL. The Malawi Developmental Assessment Tool (MDAT): the creation, validation, and reliability of a tool to assess child development in rural African settings. PLoS Med. 2010 May 25;7(5):e1000273. doi: 10.1371/journal.pmed.1000273.

  PMID: 20520849 BACKGROUND

• Palmer T, Clare A, Fearon P, Head R, Hill Z, Kagone B, Kirkwood B, Manu A, Skordis J; SUNRISE team. Cost-effectiveness of a radio intervention to stimulate early childhood development: protocol for an economic evaluation of the SUNRISE trial in Burkina Faso. BMJ Open. 2024 Apr 16;14(4):e080905. doi: 10.1136/bmjopen-2023-080905.

  PMID: 38626956 DERIVED

• Dumbaugh M, Belem M, Kousse S, Ouoba P, Sankoudouma A, Tchibozo AM, Fearon P, Hollowell J, Hill Z; SUNRISE team. 'Children awaken by playing': a qualitative exploration of caregivers' norms, beliefs and practices related to young children's learning and early childhood development in rural Burkina Faso. BMJ Open. 2023 Oct 29;13(10):e075675. doi: 10.1136/bmjopen-2023-075675.

  PMID: 37899153 DERIVED

Study Officials

• Betty R Kirkwood, FMedSci

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betty R Kirkwood, FMedSci

CONTACT

+447905978676; betty.kirkwood@LSHTM.ac.uk

Pasco Fearon, PhD

CONTACT

+447919264327; p.fearon@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This a cluster RCT. Local radio stations in the 8 intervention clusters will broadcast the SUNRISE campaign which will be promoting responsive caregiving and providing opportunities for early learning to support child development during the first 3 years of life. Radio stations in the 7 control clusters will broadcast as normal.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 years from study completion, which is anticipated to be October 2025
• Access Criteria: TBC

Locations

BU (1)