Condition category
Mental and Behavioural Disorders
Date applied
06/05/2011
Date assigned
06/06/2011
Last edited
06/06/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://mona.uwi.edu

Funders

Funder type

Research organisation

Funder name

Inter-American Development Bank (USA) Ref: ATN/SF-12300-RG

Alternative name(s)

Banco Interamericano de Desarrollo, Banco Interamericano de Desenvolvimento, Banque Interaméricaine de Développement, IDB, BID

Funding Body Type

private sector organisation

Funding Body Subtype

international

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes