Family and Childhood Development: The Next Generation ('Kizazi Kijacho')

NCT05598970 | Completed DMC

• 1 other identifier: 2022-01356-01
• Study Type: interventional
• Target: 3,585
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Children's cognitive, speech and language development

  Direct assessment and parental report will be combined. For direct assessment, the Bayley-III (Bayley, 2006) suitably adapted for Tanzanian context will be used. Cognition, receptive and expressive language subtests will be selected. For parental report, selected items of the CREDI (McCoy et al, 2018) for cognition, receptive and expressive language subtests and a short version of the MacArthur-Bates Communicative Development Inventory (Jackson, 2012) that measures expressive language will be used, both already adapted for Tanzania. Raw scores will be standardized within the study sample for analysis. The measurement of outcomes will be aggregated using SEM to get latent factor(s) that summarizes effectively the information given by the individual items. Direct assessment and parental reports will be combined as well as the different child development domains if the fit of the model(s) are better than using the original raw scoring techniques were higher scores mean better outcomes.

  Endline survey (after 15 months)

• Children's nutritional status

  Weight and height will be measured at the time of the follow-up survey to obtain the height-for-age-z-scores and weight-for-height-age-z-scores, standard measures outlined by WHO. Mid Upper Arm Circumference (MUAC) will be also collected (WHO, 2006). Scores will be standardized within the study sample for analysis, so all measures are in the same metric. The measurement of nutritional outcomes will be aggregated using Structural Equation Modeling (SEM) to get latent factor(s) that summarizes effectively the information given by the individual outcomes. Different nutritional outcomes will be combined if the fit of the model(s) are better than using the individual z-scores.

  Endline survey (after 15 months)

Secondary Outcomes (2)

• Children's socio-emotional development

  Endline survey (after 15 months)

• Child rearing practices

  15 months starting with baseline (October-December 2022) and finishing with endline survey (January-March 2024)

Study Arms (5)

Control

NO INTERVENTION

This group will serve as the Control group (81 HDs, 81 communities, 810 households) to identify the effects of a Parenting only, Unconditional Cash Transfer (UCT) only, and Parenting+UCT interventions. Caregivers will continue benefiting from a traditional government CHW home visit program, focusing on maternal and child health and nutrition, which is currently in practice in Tanzania.

Parenting only

EXPERIMENTAL

88 HDs, 77 communities, 770 households. Existing CHWs will be trained to use an innovative digital application for the delivery of integrated ECD services to mothers who are at least 20 weeks pregnant and less than 32 weeks pregnant for a period of 15 months. CHWs will provide tailored ECD services (e.g., prompting messages tailored to child age and triggering follow-up visits conditional on changing conditions), covering all aspects of the Nurturing Care Framework (Health, Nutrition, Responsive Caregiving, Early Learning, Safety and Security (WHO, UNICEF, World Bank Group, 2018)). Real time data will be recorded by the CHWs in each visit using the application. Data will include information on visit attendance, activities conducted, home environment, caregiver practices, and CHW observations. From when the target child is 6 months old, group sessions will be organised by CHWs, focusing on caregiver-child interaction and stimulation activities.

Other: Digital application supported CHW Parenting Intervention

Parenting+Unconditional Cash Transfer

EXPERIMENTAL

88 HDs, 77 communities, 770 households. In addition to the Parenting Intervention, pregnant women in the study sample will receive 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).

Other: Digital application supported CHW Parenting Intervention; Other: Unconditional Cash Transfer Intervention

Unconditional Cash Transfer only fixed amount

EXPERIMENTAL

89 HDs, 80 communities, 800 households. Households, in addition to the CHWs delivering health and nutrition services as usual, will receive a fixed bi-monthly unconditional mobile money transfer each of 109,000 TZS (47USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). The transfer will be randomly assigned between mothers and fathers/spouses within each community, where in half of the eligible households, mothers will receive the transfer and in the other half, fathers/spouses (or household head where the father/spouse is not available) will receive the transfer.

Other: Unconditional Cash Transfer only Intervention fixed amount

Unconditional Cash Transfer only vary amount

EXPERIMENTAL

89 HDs, 75 communities, 375 households. In addition to the previous four main treatment arms, there is another UCT only treatment study group where the level of the cash amount varies across communities. Communities, in addition to the CHWs delivering health and nutrition services as usual, in this group will be randomised to receive one of the bi-monthly unconditional mobile money transfer amounts: 32,000 TZS (14USD), 77,000 TZS (33USD), 109,000 TZS (47USD) from 5-7 months pregnancy over a period of 15 months (7 transfers in total). The transfers will be randomly assigned between mothers and fathers/spouses within each community, where in half of the eligible households, mothers will receive the transfer and in the other half, fathers/spouses (or household head where the father/spouse is not available) will receive the transfer.

Other: Unconditional Cash Transfer only Intervention vary amount

Interventions

Unconditional Cash Transfer Intervention OTHER

Families will receive from 5-7 months pregnancy over a period of 15 months a bi-monthly unconditional cash transfer, which equals the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under Tanzania Social Action Fund (TASAF), i.e., Tanzania's National Cash Transfer program.

Parenting+Unconditional Cash Transfer

Digital application supported CHW Parenting Intervention OTHER

All pregnant women served by the trained CHW will be invited to participate in the Parenting program, from when the mother is at least 20 weeks pregnant and less than 32 weeks pregnant with the target child for a period of 15 months. CHWs will visit pregnant women at least 3 times during their pregnancy and at least 16 times following delivery. In addition to the individual home visits, the CHWs will organise bi-weekly in-community group sessions for children aged 6-12 months and their primary caregivers, focusing on caregiver-child interaction and stimulation activities. The immediate supervisors Health Care Workers (HCWs) of the CHWs will be trained to closely monitor CHWs activities and progress made. HCWs and CHWs will in turn be supervised and supported by district level Council Health Management Team (CHMT). Parenting services will be provided to all target children of these eligible caregivers, irrespective of their learning or physical abilities.

Parenting only; Parenting+Unconditional Cash Transfer

Unconditional Cash Transfer only Intervention fixed amount OTHER

The fixed cost for delivering the Parenting only Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer fixed amount' treatment arm, the transfer will be 109,000 TZS (32,000 TZS + 77,000 TZS).

Unconditional Cash Transfer only fixed amount

Unconditional Cash Transfer only Intervention vary amount OTHER

The rationale for the levels of the varying UCT amounts is to keep them comparable with i) the bi-monthly cost of the parenting program per family, ii) the bi-monthly cash transfers disbursed under TASAF, and iii) the sum of the bi-monthly cost of the parenting program and the bi-monthly cash transfer disbursed under TASAF. The fixed cost for delivering the Parenting Intervention was calculated to be 32,000 TZS. This cost is added to the average of maximum and minimum amount transferred on a bi-monthly basis to similar pregnant women under TASAF: 77,000 TZS. Therefore, in the 'Unconditional Cash Transfer only vary amount' group, each of the amounts vary individually (32,000 TZS; 77,000 TZS; 109,000 TZS).

Unconditional Cash Transfer only vary amount

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EDI Global: collaborator
• Stockholm University: lead
• Elizabeth Glaser Pediatric AIDS Foundation (EGPAF): collaborator
• D-Tree International: collaborator
• Ifakara Health Institute (IHI): collaborator
• Yale University: collaborator
• University of Chile: collaborator
• NHH-Norwegian School of Economics: collaborator
• Chr. Michelsen Institute: collaborator

Study Sites (1)

Dodoma

Dodoma, Dodoma, Tanzania

Location

Related Publications (9)

• 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.

  BACKGROUND

• Jackson-Maldonado D. MacArthur-Bates Communicative Development Inventories. The Encyclopedia of Applied Linguistics. 2012 Nov 5.

  BACKGROUND

• 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.

  BACKGROUND

• Griffiths RB, Wheeler JC. Critical points in multicomponent systems. Physical Review A. 1970 Sep 1;2(3):1047.

  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

• Bradley, R. H, "The HOME environment," in Marc H. Bornstein, ed., Handbook of Cultural Development Science, New York: Psychology Press, 2014, pp. 505-530.

  BACKGROUND

• 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

  BACKGROUND

• Bayley, N., Bayley scales of infant and toddler development. PsychCorp., Pearson, 2006.

  BACKGROUND

• 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

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Pregnant mothers and Community Health Workers will not know about the intervention arm they will be randomised to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Clustered multi-arm Randomised Controlled Trial

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 31, 2022
• Study Start: September 26, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 4 years after endline survey or after publishing journal paper(s).

Locations

TA (1)