Impact evaluation of a psychosocial stimulation intervention on very young children living in urban poverty in India
| ISRCTN | ISRCTN89476603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89476603 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/11/2013
- Registration date
- 10/12/2013
- Last edited
- 01/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The importance of the first 5 years of life for long-term development is well-established. During this vital period the development of children living in poverty is hindered by malnutrition, illness and unstimulating home environments. Evidence shows that interventions in early childhood can be very important for psychosocial development. However, they are often delivered by experts and hence expensive and not feasible to expand widely. We will implement and evaluate a cost-effective intervention – based on Grantham-McGregor’s curriculum and delivered by local women through weekly home visits over 18 months – targeted to children aged 10-20 months and their mothers/primary caregivers. The intervention aims to promote early child development and maternal-child interactions in a very poor urban environment.
Who can participate?
Children aged 10-20 months and their mothers/primary caregivers from the 54 slums in Cuttack, Odisha, India.
What does the study involve?
The 54 slums will be randomly allocated to either the intervention or the control group. The intervention group will receive weekly home visits lasting around one hour. The 'home visitors' will be local women and will follow the Grantham-McGregors curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. The control group will receive no intervention. We will assess child development and conduct household and slum surveys before and after the intervention. We will also obtain detailed information on the quality of the home environment.
What are the possible benefits and risks of participating?
Benefits to participants include information on the child's development and also, within the intervention households, advice on how to improve child development. We do not foresee any risks for study participants.
Where is the study run from?
The Institute for Fiscal Studies (UK)
When is the study starting and how long is it expected to run for?
November 2014 to May 2015
Who is funding the study?
The study is funded by a gift from Mr Martin Rushton-Tuner and the Waterloo Foundation.
Who is the main contact?
Dr Marta Rubio-Codina (marta_r@ifs.org.uk)
Dr Britta Augsburg (brita_a@ifs.org.uk)
Contact information
Scientific
Institute for Fiscal Studies
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
Study information
| Study design | Two-arm cluster (slum) randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Early Childhood Development in the slums of Cuttack, Odisha, India |
| Study acronym | ECD Cuttack |
| Study objectives | Child cognitive and language development will be improved by introducing a systematic psychosocial stimulation curriculum delivered weekly by local women (home visitors) aimed at promoting maternal-child interactions and the quality of the home environment. |
| Ethics approval(s) | 1. IMFR, 27/06/2013, ref: IRB00007107; FWA00014616; IORG0005894 2. UCL Ethics Committee, Graduate School Office, 02/09/2013, ref: 2168/001 |
| Health condition(s) or problem(s) studied | Early childhood development |
| Intervention | Slum-based intervention to promote early childhood development. 54 clusters in total will be randomised to either the intervention or the control group. 1. Intervention group: 27 clusters will receive psychosocial stimulation through weekly home visits - lasting around one hour - to mothers/primary carers of children aged 10-20 months. The 'home visitors' will be local women and will follow the Grantham-McGregors curriculum and protocols specially adapted for the context of Odisha. They will interact with carers and children and will discuss the importance of stimulation and play for child development with the carer. 2. Control group: 27 clusters will receive no intervention. Total duration of intervention: 12 months (2 periods of 1 month of data collection will precede and follow the interventions) Updated 25/11/2015: Total duration of intervention: 18 months (2 periods of 1 month of data collection will precede and follow the interventions) |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 25/11/2015: Children’s cognitive, receptive language, expressive language, and fine motor development (assessed using Bayley-III at follow-up). Previous primary outcome measures: Children's cognitive, language, motor and socio-emotional development (ASQ-3 test at baseline; Bayley-III at follow-up or DAS-II [TBC]) |
| Secondary outcome measures | Current secondary outcome measures as of 25/11/2015: 1. Quality of the home stimulation environment (as measured by the 'play activities' and 'play materials' subscales of the Family Care Indicators) at baseline in the home; at follow-up in the assessment centre and in the home 2. Maternal time spent on high stimulation activities with children (as measured by time use module in household questionnaire) both at baseline and at follow-up in the home 3. Mother's knowledge of child development (as measured by a subset of selected items from the KIDI instrument) both at baseline and at follow-up in the home Previous secondary outcome measures: 1. Children´s height, weight and morbidity (standard WHO methods and definitions -- height and weight will only be collected at baseline) 2. Quality of the home environment: play activities and play materials (FCI instrument -- baseline and follow-up) 3. Maternal depressive symptoms (FCI questions from CES-D -- baseline and follow-up) 4. Maternal and household socio-economic characteristics (household survey -- baseline and follow-up) |
| Overall study start date | 12/08/2013 |
| Completion date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Months |
| Upper age limit | 20 Months |
| Sex | Both |
| Target number of participants | 400 children and their mothers/caregivers in 54 slums (27 treatment, 27 control) |
| Total final enrolment | 421 |
| Key inclusion criteria | 1. Children aged 10-20 months from the 54 slums in Cuttack, Odisha, India 2. Informed consent |
| Key exclusion criteria | 1. Children outside the 10-20 month age range 2. Mentally or physically disabled children 3. Children born as twins |
| Date of first enrolment | 11/11/2013 |
| Date of final enrolment | 15/12/2014 |
Locations
Countries of recruitment
- England
- India
- United Kingdom
Study participating centre
WC1E 7AE
United Kingdom
Sponsor information
Research organisation
7 Ridgmount Street
London
WC1E 7AE
United Kingdom
| Website | http://www.ifs.org.uk |
|---|---|
"ROR" |
https://ror.org/04r1cjx59 |
Funders
Funder type
Charity
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2020 | 06/12/2019 | Yes | No |
Editorial Notes
01/04/2020: There is a follow-up study to this study, which can be found at ISRCTN18263197.
06/12/2019: Publication reference and total final enrolment number added.
25/11/2015: The following changes were made to the trial record:
1. The overall trial start date was changed from 11/11/2013 to 12/08/2013.
2. The overall trial end date was changed from 15/12/2014 to 31/03/2016.
