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

Parenting Clinical Trial

Official title:

Family and Childhood Development: Kizazi Kijacho ('The Next Generation') - a Cluster Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598970
• Other study ID #: 2022-01356-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2022
• Source: Stockholm University
• Contact: Ingvild Almås, PhD
• Phone: 08-674 77 10
• Email: ingvild.almas[@]iies.su.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3525
• Est. completion date: December 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Early Child Development
• Parenting

Intervention

Other:
• Digital application supported CHW Parenting Intervention
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 amount
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 Intervention
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 amount
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).

Locations

Country	Name	City	State
Tanzania	Dodoma	Dodoma

Sponsors (9)

Lead Sponsor	Collaborator
Stockholm University	Chr. Michelsen Institute, D-Tree International, EDI Global, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Ifakara Health Institute (IHI), NHH-Norwegian School of Economics, University of Chile, Yale University

Country where clinical trial is conducted

Tanzania, 

References & Publications (9)

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

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

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

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

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

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. — View 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.

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	Endline survey (after 15 months)
Secondary	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.	15 months starting with baseline (October-December 2022) and finishing with endline survey (January-March 2024)