Contact information
Type
Scientific
Primary contact
Prof Susan Walker
ORCID ID
Contact details
Tropical Medicine Research Institute
The University of the West Indies
Mona
Kingston
7
Jamaica
-
susan.walker@uwimona.edu.jm
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Home and health centre delivery of early childhood stimulation: cluster randomised trial of the impact of interventions to improve parenting of children aged 2-18 months on child development in the Caribbean countries
Acronym
Study hypothesis
There is substantial evidence from efficacy trials of benefits to child development from parenting programs with home visits to improve mother-child interaction and demonstrate activities to promote development. The interventions were delivered by paraprofessionals who visited the homes weekly. Although low cost compared to programs in the USA, these interventions are often too expensive to take to scale in many countries. The challenge is to develop programs that are feasible at scale yet remain effective. We are evaluating a modified home visiting approach using fewer visits and materials and a new health centre approach using a specially designed video of child development messages to be shown at all child health visits from age 2-18 months.
We hypothesise:
1. A home visiting intervention delivered by trained community health workers every 2 weeks from age 6-18 months with the objective of helping mothers promote their child development will improve parent-child interaction, quality of stimulation in the home and child development.
2. A health centre based intervention at routine child health visits from age 2-18 months using videos of child development messages that demonstrate mother-child interactions followed by discussion and practice led by trained community health workers will improve parent-child interaction, quality of stimulation and child development.
Ethics approval
University Hospital of the West Indies/ University of the West Indies/ Faculty of Medical Sciences Ethics Committee aproved on 20th January 2011, Ref: ECP 18, 10/11
Study design
Multicentre cluster randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Early child development
Intervention
1. In Jamaica 20 Health centres will be randomly assigned to one of 4 groups:
1.1. Health Centre intervention
1.2. Home visit
1.3. Both interventions
1.4. Control
2. In Antigua and St Lucia 10 health centres in each country will be randomly assigned to Health centre intervention or control
3. Participants (mothers and infants) will be recruited at the health centre at the 6 week post natal clinic visit
4. Follow-up assessment will be at age 19-20 months
5. Health centre intervention: video will be developed, in collaboration with a team experienced in effective use of media for health education, to deliver a series of child development messages. The videos will be shown at all child health clinics which are scheduled at 3, 6, 9, 12 and 18 months of age.
7. In each clinic a community health worker will be trained to discuss the video messages with the mothers, demonstrate activities mothers can do with their children and how to make simple toys from household materials
8. Opportunities will be given for mothers to try some of the activities and they will be encouraged to make them part of their daily routine
9. Home visiting intervention: will be based on that used previously in Jamaica modified to increase the feasibility of scaling up
10. Visit frequency will be reduced from weekly to twice monthly and supervision will be by nurses rather than a child development specialist
11. Children will be visited from 6 to 18 months of age by trained community health workers and play sessions conducted to improve mother-child interaction and show mothers how to promote development
12. Separate training workshops will be held for the community health aides involved in the two types of interventions
13. A supervisor will provide ongoing support to implementation of the interventions
14. Control: centres will continue to provide the usual care at all child health visits
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Child Psychomotor development: Griffiths Scales of Mental Development to assess the childrens' development at age 19-20 months
2. The scales have been used frequently in Jamaica where it has good concurrent and predictive validity
3. Language development: the short version of the MacArthur Communicative Development Inventory (Short Communicative Development Inventory, CDI) will be used to measure language development based on mothers' report
Secondary outcome measures
1. Child growth: weight, length and head circumference will be measures on enrolment at age 6-8 weeks and at age 19-20 months
2. Child behaviour: ratings of behaviour during the developmental test session
3. Maternal parenting knowledge, practices and depressive symptoms will be measured on enrolment and at age 19-20 months
4. Mothers knowledge of child development will be assessed by questionnaire
5. Stimulation in the home will be assessed with a subset of questions from the Home Observations for Measurement of the Environment (HOME)
6. Maternal depressive symptoms will be assessed using the CES depression scale
Overall trial start date
15/07/2011
Overall trial end date
15/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Mothers and infants attending government (public) primary care health centres for child care
2. Mothers and infants will be recruited at the six week post natal clinics
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Total participants 600: Jamaica 400, Antigua 100, St Lucia 100
Participant exclusion criteria
1. Infants with obvious mental or physical disabilities
2. Twins
Recruitment start date
15/07/2011
Recruitment end date
15/12/2013
Locations
Countries of recruitment
Antigua and Barbuda, Jamaica, Saint Lucia
Trial participating centre
Tropical Medicine Research Institute
Kingston
7
Jamaica
Sponsor information
Organisation
The University of the West Indies (Jamaica)
Sponsor details
Tropical Medicine Research Institute
The University of the West Indies
Mona
Kingston
7
Jamaica
-
tmri.eru@uwimona.edu.jm
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Inter-American Development Bank (USA) Ref: ATN/SF-12300-RG
Alternative name(s)
Banco Interamericano de Desenvolvimento, Banque Interaméricaine de Développement, Banco Interamericano de Desarrollo, IDB, BID
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2015 results of the impact, acceptability and costs of delivering parenting interventions through health services in the Caribbean, in https://www.researchgate.net/publication/286446075 (added 21/01/2019)
2. 2015 results of integrating a parenting intervention with routine primary health care, in https://www.ncbi.nlm.nih.gov/pubmed/26148947 (added 21/01/2019)
3. 2017 results in https://doi.org/10.1080/17450128.2017.1395100 (added 21/01/2019)