Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour

NCT03281980 | Unknown

• 1 other identifier: PR-17009
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. 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 Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour. Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development. Primary Hypothesis (if any):

• Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group.
• Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups Secondary Hypothesis: Additionally the intervention will
• be cost effective,
• reduce mothers' depressive symptoms and improve their self esteem
• improve children's growth and household food security status
• reduce domestic violence
• Health seeking behaviour and health care expenditure Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country. Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.

Conditions

Child Development; Child Behavior

Keywords

Bangladesh; Child development; Poor mothers; Psycho social stimulation; Unconditional cash transfer

Outcome Measures

Primary Outcomes (2)

• Child development composite score

  Children's cognition, language and motor as composite score

  Change children's cognition, language and motor as composite score after one year intervention

• Children's behavior and composite score

  Children's behavior will be measured by Wolk's behavior rating scale during bayley

  Change children's behaviour after one year intervention

Secondary Outcomes (13)

• Children's weight

  Change children's weight after one year intervention

• Children's height

  Change children's height after one year intervention

• Children's Mid Upper Arm circumference (MUAC)

  Change children's MUAC after one year intervention

• Mothers' weight

  Change mother's weight after one year intervention

• Mothers' height

  Change mother's height after one year intervention

Study Arms (3)

Intervention (UCT+HE+PS)

EXPERIMENTAL

The participants of this arm will receive UCT and HE along with psychosocial stimulation (PS)

Other: Psychosocial stimulation (PS)

Government Intervention (UCT+HE)

SHAM COMPARATOR

The participants of this arm will receive only UCT and HE

Other: Government Intervention (UCT+HE)

Comparison

NO INTERVENTION

Interventions

Psychosocial stimulation (PS) OTHER

i) Unconditional Cash Transfer(UCT)/ Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each mother up to two years in each month. ii) Health Education Awareness Program: All mothers receive health education training by designated LNGOs/CBOs iii) Psychosocial stimulation: The participants will receive fortnightly sessions at home.

Intervention (UCT+HE+PS)

Government Intervention (UCT+HE) OTHER

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Government Intervention (UCT+HE)

Eligibility Criteria

• Age: 6 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mothers with a child aged 6-16 months
• Eligible to receive UCT.
• UCT+HE+PS arm: Receiving unconditional cash from government
• UCT+HE arm: Receiving unconditional cash from government
• Comparison arm: eligible to receive UCT but not under UCT programme.
• Not expected to leave the study site for more than 2 months
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

You may not qualify if:

• Legal guardian unwilling or unable to provide written informed consent.
• Known congenital anomaly
• Developmental disorder or severe developmental delay
• Not possible to test the child due to physical or behavioral problems
• Children of multiple birth e.g. twin, triplets

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Upazilla

Sirajganj, 6761, Bangladesh

Location

Related Publications (14)

• 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.

  PMID: 27717614 BACKGROUND

• 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.

  PMID: 20214083 BACKGROUND

• Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.

  PMID: 25266433 BACKGROUND

• van Doorslaer E, O'Donnell O, Rannan-Eliya RP, Somanathan A, Adhikari SR, Garg CC, Harbianto D, Herrin AN, Huq MN, Ibragimova S, Karan A, Ng CW, Pande BR, Racelis R, Tao S, Tin K, Tisayaticom K, Trisnantoro L, Vasavid C, Zhao Y. Effect of payments for health care on poverty estimates in 11 countries in Asia: an analysis of household survey data. Lancet. 2006 Oct 14;368(9544):1357-64. doi: 10.1016/S0140-6736(06)69560-3.

  PMID: 17046468 BACKGROUND

• 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.

  PMID: 18328930 BACKGROUND

• Grantham-McGregor SM, Powell CA, Walker SP, Himes JH. Nutritional supplementation, psychosocial stimulation, and mental development of stunted children: the Jamaican Study. Lancet. 1991 Jul 6;338(8758):1-5. doi: 10.1016/0140-6736(91)90001-6.

  PMID: 1676083 BACKGROUND

• Hamadani JD, Huda SN, Khatun F, Grantham-McGregor SM. Psychosocial stimulation improves the development of undernourished children in rural Bangladesh. J Nutr. 2006 Oct;136(10):2645-52. doi: 10.1093/jn/136.10.2645.

  PMID: 16988140 BACKGROUND

• Nahar B, Hossain MI, Hamadani JD, Ahmed T, Huda SN, Grantham-McGregor SM, Persson LA. Effects of a community-based approach of food and psychosocial stimulation on growth and development of severely malnourished children in Bangladesh: a randomised trial. Eur J Clin Nutr. 2012 Jun;66(6):701-9. doi: 10.1038/ejcn.2012.13. Epub 2012 Feb 22.

  PMID: 22353925 BACKGROUND

• Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.

  PMID: 23616511 BACKGROUND

• Gardner JM, Powell CA, Baker-Henningham H, Walker SP, Cole TJ, Grantham-McGregor SM. Zinc supplementation and psychosocial stimulation: effects on the development of undernourished Jamaican children. Am J Clin Nutr. 2005 Aug;82(2):399-405. doi: 10.1093/ajcn.82.2.399.

  PMID: 16087985 BACKGROUND

• Fernald LC, Gertler PJ, Neufeld LM. 10-year effect of Oportunidades, Mexico's conditional cash transfer programme, on child growth, cognition, language, and behaviour: a longitudinal follow-up study. Lancet. 2009 Dec 12;374(9706):1997-2005. doi: 10.1016/S0140-6736(09)61676-7.

  PMID: 19892392 BACKGROUND

• Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.

  PMID: 23453283 BACKGROUND

• Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3.

  PMID: 18772893 BACKGROUND

• Hossain SJ, Roy BR, Salveen NE, Hasan MI, Tipu SMMU, Shiraji S, Tofail F, Hamadani JD. Effects of adding psychosocial stimulation for children of lactating mothers using an unconditional cash transfer platform on neurocognitive behavior of children in rural Bangladesh: protocol for a cluster randomized controlled trial. BMC Psychol. 2019 Mar 5;7(1):13. doi: 10.1186/s40359-019-0289-9.

  PMID: 30836984 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The testers of the participants will not have the information about type of intervention of the children
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: September 13, 2017
• Study Start: August 20, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-02

Locations

BA (1)