- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432971
Parenting and Unconditional Cash on Children's Development at Middle Childhood
Follow-up of Parenting and Unconditional Cash on Children's Development at Middle Childhood
Background (brief):
- Burden: There are around 250 millions children in low and middle income countries who do not reach their developmental potential. This developmental delay sustains to middle childhood on their IQ, educational learning and performance to adulthood on their income and quality of life.
- Knowledge gap: There are little evidence on impact of early (at age 0-2 years) intervention on middle- childhood
- Relevance: Parenting and unconditional cash was found to improve children's development and maternal well-being immediate after the intervention when children's age was 6-16 months at enrolment. Now the children's age are 6-9 years old. This follow-up study will evident the impact of early intervention on children's development at middle -childhood and their maternal well-being.
Hypothesis (if any): The hypothesize was that the intervention at early age will have an impact on -
- Children' IQ (primary outcomes) and
- Their learning achievement
- Middle childhood home environment
- Mothers' depressive symptoms and quality of life
- Mothers' exposure to domestic violence, and women's empowerment (e.g. participation in decision making on family affairs, freedom of movement) compared to only unconditional cash
Methods: It is a longitudinal study. We will follow all the mother and child dyads who participated at their early childhood.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is estimated that 250 million children do not reach their potential due to poverty, inadequate stimulation and associated risk factors in low and middle income countries. Although early years (0-3 years) are very important for brain development of a child, some factors including extreme poverty, stunting, lack of psychosocial stimulation and safety net are barriers for their smooth development. The early intervention e.g. psychosocial stimulation returns maximum of investment at this age (0-3 years) because the stimulation and interaction with caregivers increases neuronal connections in children's brains. Investment in health and education has been documented as a way to improve human capital and rapid economic growth. Intervention in early age has the highest returns in adult life. Indeed, early years investment in children is a unique window of opportunity to improve individual, community, and societal outcomes as a whole.
More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty. Ministry of Women and Children's Affairs (MOWCA), Government of Bangladesh (GOB) introduced maternity allowance in the fiscal year 2007-2008. This is an unconditional cash transfer under safety net program for the poor mothers. The overall objective of the cash program is to ensure safety net in terms of morbidity, mortality and welfare during pregnancy and lactation period for both mother and child.
Parenting alone and along with other health and nutrition programs was found to be effective for children's cognition and behavior. Conditional and unconditional cash transfer to the poor mothers has proved a way of reducing poverty and improving health outcomes for mothers and children worldwide. Conditional cash transfer (CCT) alone was also found significantly effective for child development in Mexico. On the other hand, studies reported that unconditional cash transfer (UCT) improved other health outcomes and nutrition.
There is a constitutional obligation of government of Bangladesh (GoB) to ensure public health and nutrition, especially for disadvantages people. GoB is a signatory and ratified country of The United Nations Convention on the Rights of the Child (UNCRC). Through this ratification GoB has given mandate to serve the needs of children in the country. GoB developed health policy and national children policy emphasizing health care for the disadvantages and the poor. MoWCA revised 'the National Child Policy 1994' in 2011. The first aim and objective of 'the National Children Policy 2011' is to ensure best child development and growth of the children in the country irrespective of any economic, social, gender and geographical barriers. The present study completely is aligned with the Children Policy 2011.
Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact, urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and children are vulnerable in terms of health and education.
The urban health care facilities are fragmented and patchy and every year rise in population is putting more pressure on health system. Moreover, there is huge economic disparity between rich and poor in the urban areas and poorer people have little access to health care due to both supply and demand barriers. So the situation is rolling more difficult every day.
Very few ECD programs are available for poor urban children especially for the 1st thousand days. the idea is to develop a combined package integrating parenting with the existing urban lactating allowance program and measuring its synergistic effects on disadvantaged children's development.
Government of Bangladesh (GoB) has developed health policy and national health policy in 2011 emphasizing health care for the disadvantaged and the poor. Recently GOB has also developed urban health strategy to focus health of urban people. It is implementing fifth Health, Population and Nutrition Sector Program (HPNSP) 2017-2021 for ensuring health and nutrition of the people giving priority to the vulnerable population.
Considering above scenarios, a cluster randomized controlled trial was conducted with mothers of children aged 6-16 months in urban (Rangpur City Corporation) areas of Bangladesh.
The urban study, participants were randomised to receive i) parenting and unconditional cash (n=299), or ii) unconditional cash only (n=300). Children of mothers who received both interventions had significantly higher cognitive and language development compared to the children of mothers who received unconditional cash only. The combined intervention also led to significant reductions to maternal depressive symptoms and violence against women.
Both the studies were implemented in collaboration with the Ministry of Women and Children Affairs (MoWCA), Government of Bangladesh (GoB) using the national social safety-net programme (unconditional cash for pregnant and lactating mothers). This programme is continuing in the country with all targeted poor pregnant and lactating women eligible to receive the unconditional cash in the name of Maternal and Child Benefits Programme (MCBP).
Since there is scarcity of evidence about the sustainability of the programme over time, follow-up of these cohort is important to gain a more comprehensive understanding of the benefits of these interventions over the life course. To our knowledge, this would be the first follow-up study of a combined parenting and unconditional cash transfer programme to investigate the medium-term effects on children's development and maternal well-being. It was hypothesized that the children who received cash and parenting intervention will have better IQ and learning outcomes compare to the children of no intervention.
With the plan of this study was to collect data from the mothers and children who participated in the original randomised trial of the parenting and cash transfer interventions. It was also planed to add one arm of pure control-who did not receive unconditional cash in the urban study for better understanding of effect of cash on children's development and mothers' well-being. In total, in the original study, 300 mother and child dyads were enrolled to make this new arm. At this follow-up, another arm of true control was added that included participants who had not received parenting support or participated in the GoB social protection programme. The sample was selected matching for child's age (± 6 months of the mean age of the study children), child sex, family income and location. The field staff visited the study area and conducted a door-to-door survey to identify children who fulfilled the selection criteria. The first 15 mother/child dyads found in each cluster, were enrolled.
After checking the data, necessary coding and recoding will be made. Some new indices will be created e.g. Corwding index (total households number divided by total number of bed rooms), housing index: considering materials used for floor, wall and roof. Body mass index of the mothers and Z-score of anthropometries of the children will also be developed. Then all data will be presented in a table by groups (intervention, comparison, only cash). Data will be presented with their Background characteristics of the studies will be presented as mean (sd) for continuous data and proportion for categorical data. Data will be analysed using intention to treat to see the effect at this follow-up. The effect of the intervention will be examined using linear regression for continuous data and logistic regression for dichotomous data controlling for baseline outcomes and adjusted for clustering.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rangpur City, Bangladesh
- Rangpur City Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All mother and child dyads participated immediately after the parenting intervention were enrolled in this follow-up. Mothers were enrolled in the original trial who participated in the unconditional cash transfer programme (social protection programme).The eligibility criteria for enrollment into the Government of Bangladesh social protection programme were-
- urban working mothers
- income less than 1500 BDT (<17.6 USD; Ref: World Bank 2020y) per month per mother
- having less than three children, and
- permanent residence in the urban area
Exclusion Criteria:
- Known health problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm-I (Intervention)
Early parenting with government unconditional cash
|
parenting through home visit, fortnightly by a trained community volunteer
Other Names:
|
|
No Intervention: Arm-II (comparison)
Only government unconditional cash
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child's Intelligent Quotient
Time Frame: Through study completion, an average of 5 year after intervention
|
Wechsler Intelligence Scale for Children-V was used to measure child's Intelligent Quotient, Higher score mean higher Intelligent Quotient
|
Through study completion, an average of 5 year after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child's reading and mathematics performance
Time Frame: Through study completion, an average of 5 year after intervention
|
Child's reading and mathematics performance was measured using early grade reading assessment and mathematics assessment, higher score mean better performance
|
Through study completion, an average of 5 year after intervention
|
|
Child quality of home stimulation environment
Time Frame: Through study completion, an average of 5 year after intervention
|
Child quality of home stimulation environment was measured using Middle-childhood HOME, higher scores mean better home stimulation
|
Through study completion, an average of 5 year after intervention
|
|
Maternal mental health (depressive symptoms)
Time Frame: Through study completion, an average of 5 year after intervention
|
Maternal mental health (depressive symptoms) was measured using Self reported Questionnaire (SRQ-20), higher scores mean higher depressive condition
|
Through study completion, an average of 5 year after intervention
|
|
Maternal (women) empowerment (freedom of mobility and decision sharing of household purchasing)
Time Frame: Through study completion, an average of 5 year after intervention
|
Maternal (women) empowerment (freedom of mobility and decision sharing of household purchasing) using a a questionnaire, higher scores mean better status
|
Through study completion, an average of 5 year after intervention
|
|
Household violence against women (mother)
Time Frame: Through study completion, an average of 5 year after intervention
|
Household violence against women (mother) measured by a questionnaire, higher scores mean worse condition
|
Through study completion, an average of 5 year after intervention
|
|
Maternal quality of life
Time Frame: Through study completion, an average of 5 year after intervention
|
Maternal quality of life measured by WHO-QOLBREF questionnaire, higher scores mean better quality of life
|
Through study completion, an average of 5 year after intervention
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Lu C, Black MM, Richter LM. Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health. 2016 Dec;4(12):e916-e922. doi: 10.1016/S2214-109X(16)30266-2. Epub 2016 Oct 4.
- Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.
- Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010 Feb;28(1):23-33. doi: 10.3329/jhpn.v28i1.4520.
- Fernald LC, Gertler PJ, Neufeld LM. Role of cash in conditional cash transfer programmes for child health, growth, and development: an analysis of Mexico's Oportunidades. Lancet. 2008 Mar 8;371(9615):828-37. doi: 10.1016/S0140-6736(08)60382-7.
- Adams AM, Ahmed T, El Arifeen S, Evans TG, Huda T, Reichenbach L; Lancet Bangladesh Team. Innovation for universal health coverage in Bangladesh: a call to action. Lancet. 2013 Dec 21;382(9910):2104-11. doi: 10.1016/S0140-6736(13)62150-9. Epub 2013 Nov 21.
- Altman DG, Dore CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990 Jan 20;335(8682):149-53. doi: 10.1016/0140-6736(90)90014-v.
- Andrew A, Attanasio O, Augsburg B, Day M, Grantham-McGregor S, Meghir C, Mehrin F, Pahwa S, Rubio-Codina M. Effects of a scalable home-visiting intervention on child development in slums of urban India: evidence from a randomised controlled trial. J Child Psychol Psychiatry. 2020 Jun;61(6):644-652. doi: 10.1111/jcpp.13171. Epub 2019 Dec 3.
- Kilburn K, Thirumurthy H, Halpern CT, Pettifor A, Handa S. Effects of a Large-Scale Unconditional Cash Transfer Program on Mental Health Outcomes of Young People in Kenya. J Adolesc Health. 2016 Feb;58(2):223-9. doi: 10.1016/j.jadohealth.2015.09.023. Epub 2015 Nov 11.
- Arsenault C, Jordan K, Lee D, Dinsa G, Manzi F, Marchant T, Kruk ME. Equity in antenatal care quality: an analysis of 91 national household surveys. Lancet Glob Health. 2018 Nov;6(11):e1186-e1195. doi: 10.1016/S2214-109X(18)30389-9.
- Daelmans B, Black MM, Lombardi J, Lucas J, Richter L, Silver K, Britto P, Yoshikawa H, Perez-Escamilla R, MacMillan H, Dua T, Bouhouch RR, Bhutta Z, Darmstadt GL, Rao N; steering committee of a new scientific series on early child development. Effective interventions and strategies for improving early child development. BMJ. 2015 Sep 14;351:h4029. doi: 10.1136/bmj.h4029. No abstract available.
- Hossain SJ, Roy BR, Sujon HM, Tran T, Fisher J, Tofail F, El Arifeen S, Hamadani JD. Effects of integrated psychosocial stimulation (PS) and Unconditional Cash Transfer (UCT) on Children's development in rural Bangladesh: A cluster randomized controlled trial. Soc Sci Med. 2022 Jan;293:114657. doi: 10.1016/j.socscimed.2021.114657. Epub 2021 Dec 15.
- Hossain SJ, Rahman SM, Fisher J, Rahman A, Tofail F, Hamadani JD. Effect of a parenting and nutrition education programme on development and growth of children using a social safety-net platform in urban Bangladesh: a cluster randomized controlled trial. Lancet Reg Health Southeast Asia. 2024 Mar 19;25:100388. doi: 10.1016/j.lansea.2024.100388. eCollection 2024 Jun.
- Sartorius N, Janca A. Psychiatric assessment instruments developed by the World Health Organization. Soc Psychiatry Psychiatr Epidemiol. 1996 Mar;31(2):55-69. doi: 10.1007/BF00801901.
- Stewart RC, Kauye F, Umar E, Vokhiwa M, Bunn J, Fitzgerald M, Tomenson B, Rahman A, Creed F. Validation of a Chichewa version of the self-reporting questionnaire (SRQ) as a brief screening measure for maternal depressive disorder in Malawi, Africa. J Affect Disord. 2009 Jan;112(1-3):126-34. doi: 10.1016/j.jad.2008.04.001. Epub 2008 May 27.
- Tsutsumi A, Izutsu T, Kato S, Islam MA, Yamada HS, Kato H, Wakai S. Reliability and validity of the Bangla version of WHOQOL-BREF in an adult population in Dhaka, Bangladesh. Psychiatry Clin Neurosci. 2006 Aug;60(4):493-8. doi: 10.1111/j.1440-1819.2006.01537.x.
Helpful Links
- Measuring early learning quality outcomes (MELQO): Overview of the measuring early learning quality and outcomes initiative
- Promoting Early Childhood Development through Combining Cash Transfers and Parenting Programs
- Promoting positive parenting practices in Niger through a cash transfer programme
- The Impact of Cash Transfers: A Review of the Evidence from Low- and Middle-income Countries
- Sanyal, D. The Validation of the Bengali Version of the Self-Rating Questionnaire (SRQ). Indian Journal of Clinical Psychology.
- De Hoop, Jacobus Joost; C. Rosati, Furio. Cash transfers and child labor (English). Washington, D.C. : World Bank Group. http://documents.worldbank.org/curated/en/389171488453865456
- Denboba, Amina; Hasan, Amer; Wodon, Quentin. Denboba, Amina; Hasan, Amer; Wodon, Quentin, editors. 2015. Early Childhood Education and Development in Indonesia: An Assessment of Policies Using SABER. World Bank Study;. © World Bank.
- Dey, B. K. ., Rahman, A., & Akther, Y. . (2024). Teacher's Self-Esteem and Job Satisfaction: Pilot Study in Chittagong Region. Chittagong University Journal of Biological Sciences, 8(1), 107-116.
- WHOQOL-BREF : introduction, administration, scoring and generic version of the assessment : field trial version, December 1996
- WHO multi-country study on women's health and domestic violence against women
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PR-24072
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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