Clinical trial NCT05598970: Family and Childhood Development: The Next Generation ('Kizazi Kijacho')
Official title: Family and Childhood Development: Kizazi Kijacho ('The Next Generation') - a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Early Child Development
Keywords: Early Childhood Development
Unconditional Cash Transfer
Parenting
Randomized Controlled Trial
Women's empowerment
Household's decision making
Implementation science
Inequality
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: EDI Global
name: Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
name: D-Tree International
name: Ifakara Health Institute (IHI)
name: Yale University
name: University of Chile
name: NHH-Norwegian School of Economics
name: Chr. Michelsen Institute
First posted: 2022-10-31
Enrollment: 3525
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clustered multi-arm Randomised Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Digital solutions can significantly improve the delivery of Early Childhood Development (ECD) services in Low- and Middle-Income Countries (LMICs). Traditional home-visits and community group-based parenting approaches require intense levels of training, mentoring and supervision of Community Health Workers (CHWs) that is difficult to sustain when transitioning to scale. Context relevant digital tools can support CHWs in delivering high-quality, respectful, and standardised multi-sectoral household ECD services by tailoring services to pregnant women and engaging male caregivers. This could have significant impacts on child development, including stimulation, speech and language development, nutrition, and cognition. Moreover, cash delivered through digital modes of payment is faster, safer, easier to administer, is scalable and has potential to empower women, influence parental investment and affect household decision making. The study will conduct a clustered multi-arm Randomised Controlled Trial (cRCT) targeting pregnant mothers across all 7 districts (and all 8 district councils) in the Dodoma region in Tanzania. Following the study sample for 15 months from 5-7 months pregnancy. The study will test and compare the causal effects of (i) a digitally supported Parenting Intervention delivered by CHWs, which aims to improve caregivers' access to quality ECD services; (ii) a mobile unconditional cash transfer which aims to relax financial resource constraints; and (iii) a digitally supported Parenting Intervention when combined with a mobile unconditional cash transfer. Findings from the study are expected to have important policy implications for the design of scalable ECD interventions targeting pregnant mothers in Tanzania and other LMIC settings.

Detailed description: The study will randomly sample 258 public Health Dispensaries (with at least one officially registered Community Health Worker (CHW) working at the facility) across all 7 districts (and all 8 district councils) in the Dodoma region, Tanzania, to participate in a clustered multi-arm Randomised Controlled Trial (cRCT). The 258 Health Dispensaries (HDs) will be randomised to a (i) Control group (81 HDs) where CHWs deliver Early Childhood Development (ECD) services as per existing government guidelines, (ii) Parenting group (88 HDs) where existing CHWs will be trained to use an innovative digital application for the delivery of integrated ECD services for a period of 15 months, from 5-7 months pregnancy onwards and, (iii) an Unconditional Cash Transfer (UCT) only group (89 HDs) where CHWs deliver ECD services as per existing government guidelines but where the study sample of families will receive a bi-monthly UCT fixed amount of 109,000 TZS (equivalent to 47USD) for 15 months (7 transfers in total). The randomisation will be stratified by district council and by whether there is more than one community in the HD catchment area.

Within each of the HD catchment areas in the Control group, one village (in rural areas) or one 'mtaa' (in urban areas) served by the HD and where at least one officially registered CHW is available to work will be randomly sampled. For the 88 Parenting HDs and the 89 UCT only HDs, all villages/mtaas (with at least one available officially registered CHW) will be included in their catchment area to become part of the study. In total, that will give 390 study villages/mtaas in the study sample.

Within each of the selected study villages/mtaas, one CHW will be selected whose catchment area will become the geographic area of interest, i.e., the study community. The study community can be the entire village, a hamlet (sub-village) or an mtaa, depending on the size of the CHW's catchment area. This gives a total of 82 Control communities, 155 Parenting communities, and 155 UCT communities in the study.

Within the Parenting and UCT only study groups, then second layer of randomisation will be done. In the Parenting group (154 communities across 88 HDs), communities will be randomly assigned, stratified by HD, to either one of the following two treatment arms: (i) Parenting only (77 communities) and (ii) Parenting+UCT (77 communities) where the Parenting Intervention will be delivered along with a bi-monthly unconditional mobile money transfer of 77,000 TZS (33 USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). In the UCT only group (155 communities across 89 HDs), study communities will be randomly assigned, stratified by HDs, to either one of two treatment arms: (i) UCT only fixed amount (80 communities) where families will receive a fixed bi-monthly cash transfers each of 109,000 TZS (47 USD) over a period of 15 months (7 transfers in total) and (ii) UCT only vary amount where 77 communities will be randomly allocated to one of the following bi-monthly UCT amounts: 32,000 TZS (14 USD), 77,000 TZS (33 USD), 109,000 TZS (47 USD) over a period of 15 months (7 transfers in total). In each of these two study arms, further randomisation will be done whether the mobile money transfer is given to the father/spouse or the mother.

10 eligible women per community will de randomly sampled to participate in the study, except the bi-monthly UCT vary amount group, where only 5 eligible women per community will be randomly sampled.

Such a design allows to assess the relative cost-effectiveness of the Parenting and/or UCT only fixed amount interventions, and indeed provide insights into the value of adding a parenting component to a social protection program such as the Tanzania Social Action Fund (TASAF).

Additionally, the study will also explore CHW performance, quality of care delivered and other fidelity indicators to analyse impacts based on implementation effectiveness.

Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 18 years or above, who are living in the select study communities and who are at least 20 weeks pregnant and less than 32 weeks pregnant at the time of the baseline data collection survey visit to the study community region, Tanzania.

Exclusion Criteria:

* Households without pregnant women aged 18 years or above, who are living in the select study communities and who are at least 20 weeks pregnant and less than 32 weeks pregnant at the time of the baseline data collection survey visit to the study community region, Tanzania.
* If the pregnancy does not result in a live birth after enrolment, the respondent will be excluded from the study at the time of endline survey.

Primary outcomes:
measure: Children's cognitive, speech and language development
timeFrame: Endline survey (after 15 months)
measure: Children's nutritional status
timeFrame: Endline survey (after 15 months)
Secondary outcomes:
measure: Children's socio-emotional development
timeFrame: Endline survey (after 15 months)
measure: Child rearing practices
timeFrame: 15 months starting with baseline (October-December 2022) and finishing with endline survey (January-March 2024)
Other outcomes:
Locations:
city: Dodoma
country: Tanzania
facility: Dodoma
Study officials:
References:
citation: McCoy, D.C., Marcus W., and Günther F., "Measuring early childhood development at a global scale: Evidence from the Caregiver-Reported Early Development Instruments," Early Childhood Research Quarterly, 10 2018, 45, 58-68.
citation: Jackson-Maldonado D. MacArthur-Bates Communicative Development Inventories. The Encyclopedia of Applied Linguistics. 2012 Nov 5.
citation: World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development. World Health Organization; 2006.
citation: Griffiths RB, Wheeler JC. Critical points in multicomponent systems. Physical Review A. 1970 Sep 1;2(3):1047.
citation: 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.
citation: Bradley, R. H, "The HOME environment," in Marc H. Bornstein, ed., Handbook of Cultural Development Science, New York: Psychology Press, 2014, pp. 505-530.
citation: Bornstein, M. H., Tamis-LeMonda, C. S., Pascual, L., Haynes, O. M., Painter, K., Galperín, C., & Pêcheux, M.-G. Ideas about parenting in Argentina, France, and the United States. International Journal of Behavioral Development, 1996, 19, 347-367. https://doi.org/10.1177/016502549601900207
citation: Bayley, N., Bayley scales of infant and toddler development. PsychCorp., Pearson, 2006.
citation: World Health Organization, United Nations Children's Fund, World Bank Group. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO. https://apps.who.int/iris/bitstream/handle/10665/272603/9789241514064-eng.pdf