NCT03281980

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

Status unknown NA Last updated 30 March 2021

What this trial tests

NA trial testing Psychosocial stimulation (PS) in Child Development in 600 participants. Status unknown.

Timeline

20 August 2017

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	600
Start date	20 August 2017
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across Bangladesh

Drugs / interventions tested

• Psychosocial stimulation (PS)
• Government Intervention (UCT+HE)

Conditions studied

• Child Development — all drugs for Child Development →
• Child Behavior — all drugs for Child Behavior →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 6 Months to 16 Months, any sex, with Child Development or Child Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
2. 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.
   Hossain SJ, Roy BR, Salveen NE, Hasan MI, et al · · 2019 · cited 5× · PMID 30836984 · DOI 10.1186/s40359-019-0289-9