ParentingNCT05598970
Family and Childhood Development: The Next Generation ('Kizazi Kijacho')
A study testing Digital application supported CHW Parenting Intervention, Unconditional Cash Transfer only Intervention fixed amount and Unconditional Cash Transfer Intervention in people with Parenting and Early Child Development, run by Stockholm University at 1 site in Tanzania.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting, Early Child Development
- What is being tested?
- Digital application supported CHW Parenting Intervention, Unconditional Cash Transfer only Intervention fixed amount and Unconditional Cash Transfer Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,585 participants
- Where
- 1 siteTanzania
- Study dates
- 26 Sep 2022to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family and Childhood Development: Kizazi Kijacho ('The Next Generation') - a Cluster Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Parenting, Early Child Development
- Being tested
- Digital application supported CHW Parenting Intervention, Unconditional Cash Transfer only Intervention fixed amount, Unconditional Cash Transfer Intervention, Unconditional Cash Transfer only Intervention vary amount
- Keywords
- Early Childhood Development, Unconditional Cash Transfer, Parenting, Randomized Controlled Trial, Women's empowerment, Household's decision making, Implementation science, Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital application supported CHW Parenting InterventionOther
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.
Unconditional Cash Transfer only Intervention fixed amountOther
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 InterventionOther
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.
Unconditional Cash Transfer only Intervention vary amountOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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. Receives: Other: Unconditional Cash Transfer only Intervention vary amount |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Endline survey (after 15 months)
Secondary outcomes (2)
Children's socio-emotional development
Direct assessment and parental report will be combined. For the direct assessment, the Griffiths Developmental Scale III (Griffiths, 1970) personal-social-emotional subtest, suitably adapted for the context, will be used. For the parental report, selected items of the Caregiver Reported Early Development Instruments (CREDI) (McCoy, Marcus and Gunther, 2018) for the socio-emotional subtest which is already adapted for Tanzanian context and is free to use will be used. 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 if the fit of the model(s) are better than using the original raw scoring techniques were higher scores mean better outcomes.
Measured: Endline survey (after 15 months)
Child rearing practices
The presence of toys and learning materials in the house will be assessed together with parental involvement with the child, the child's routines and organisation of the child's time inside and outside the family house. This will be assessed using the Family Care Indicators, developed by UNICEF (FCI) (Kariger, et al, 2012), selected subscales of the Home Observation for the Measurement of the Environment (HOME) (Bradley, 2014) and the Parental Style (PSQ) (Bornstein et al, 1996) for assessing social and didactic interactions. The measurement of outcomes will be aggregated using SEM to get latent factor(s) that summarises the information given by the individual items on time and monetary parental investments.
Measured: 15 months starting with baseline (October-December 2022) and finishing with endline survey (January-March 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start26 Sep 2022
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clustered multi-arm Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- EDI Global, Elizabeth Glaser Pediatric AIDS Foundation, D-Tree International, Ifakara Health Institute, Yale University, University of Chile, NHH-Norwegian School of Economics, Chr. Michelsen Institute
- Responsible party
- Principal investigator, Ingvild Almås, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598970
- Sponsor's protocol ID
- 2022-01356-01
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised Individual Participant Data will be shared 4 years after the endline survey of the study or after publishing journal paper(s).
Publications
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.
Jackson-Maldonado D. MacArthur-Bates Communicative Development Inventories. The Encyclopedia of Applied Linguistics. 2012 Nov 5.
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.
Griffiths RB, Wheeler JC. Critical points in multicomponent systems. Physical Review A. 1970 Sep 1;2(3):1047.
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.
PubMed 23304914Bradley, R. H, "The HOME environment," in Marc H. Bornstein, ed., Handbook of Cultural Development Science, New York: Psychology Press, 2014, pp. 505-530.
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
Bayley, N., Bayley scales of infant and toddler development. PsychCorp., Pearson, 2006.
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family and Childhood Development: Kizazi Kijacho ('The Next Generation') - a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05598970
- Acronym / sponsor ID
- 2022-01356-01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,585 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- EDI Global, Elizabeth Glaser Pediatric AIDS Foundation, D-Tree International, Ifakara Health Institute, Yale University, University of Chile, NHH-Norwegian School of Economics, Chr. Michelsen Institute
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Clustered multi-arm Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Digital application supported CHW Parenting Intervention88 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. |
| Parenting+Unconditional Cash Transfer | Experimental | Other: Digital application supported CHW Parenting Intervention, Other: Unconditional Cash Transfer Intervention88 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). |
| Unconditional Cash Transfer only fixed amount | Experimental | Other: Unconditional Cash Transfer only Intervention fixed amount89 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. |
| Unconditional Cash Transfer only vary amount | Experimental | Other: Unconditional Cash Transfer only Intervention vary amount89 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital application supported CHW Parenting InterventionAll 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. | Other | Parenting only, Parenting+Unconditional Cash Transfer |
| Unconditional Cash Transfer only Intervention fixed amountThe 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). | Other | Unconditional Cash Transfer only fixed amount |
| Unconditional Cash Transfer InterventionFamilies 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. | Other | Parenting+Unconditional Cash Transfer |
| Unconditional Cash Transfer only Intervention vary amountThe 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). | Other | Unconditional Cash Transfer only vary amount |
Primary outcome
Children's cognitive, speech and language development
Time frame: Endline survey (after 15 months)
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.
Children's nutritional status
Time frame: Endline survey (after 15 months)
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.
2 secondary outcomes
Children's socio-emotional development
Time frame: Endline survey (after 15 months)
Child rearing practices
Time frame: 15 months starting with baseline (October-December 2022) and finishing with endline survey (January-March 2024)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- BackgroundMcCoy, 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.
- BackgroundJackson-Maldonado D. MacArthur-Bates Communicative Development Inventories. The Encyclopedia of Applied Linguistics. 2012 Nov 5.
- BackgroundWorld 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.
- BackgroundGriffiths RB, Wheeler JC. Critical points in multicomponent systems. Physical Review A. 1970 Sep 1;2(3):1047.
- Background: PubMed 23304914Kariger 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.
- BackgroundBradley, R. H, "The HOME environment," in Marc H. Bornstein, ed., Handbook of Cultural Development Science, New York: Psychology Press, 2014, pp. 505-530.
- BackgroundBornstein, 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
- BackgroundBayley, N., Bayley scales of infant and toddler development. PsychCorp., Pearson, 2006.
- BackgroundWorld 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
- Individual participant dataSharing planned: Yes. Anonymised Individual Participant Data will be shared 4 years after the endline survey of the study or after publishing journal paper(s).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital application supported CHW Parenting Intervention, Unconditional Cash Transfer only Intervention fixed amount and Unconditional Cash Transfer Intervention in people with Parenting and Early Child Development, run by Stockholm University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's cognitive, speech and language development (time frame: Endline survey (after 15 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598970, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.