Evaluation of parenting interventions to promote child development through home visits or a health centre based approach in three Caribbean countries

ISRCTN	ISRCTN43108304
DOI	https://doi.org/10.1186/ISRCTN43108304
Secondary identifying numbers	N/A

Submission date: 06/05/2011
Registration date: 06/06/2011
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Susan Walker
Scientific

Tropical Medicine Research Institute
The University of the West Indies
Mona
Kingston
7
Jamaica

Email	susan.walker@uwimona.edu.jm

Study information

Study design	Multicentre cluster randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
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	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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	15/07/2011
Completion date	15/12/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Total participants 600: Jamaica 400, Antigua 100, St Lucia 100
Key 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
Key exclusion criteria	1. Infants with obvious mental or physical disabilities 2. Twins
Date of first enrolment	15/07/2011
Date of final enrolment	15/12/2013

Locations

Countries of recruitment

Antigua and Barbuda
Jamaica
Saint Lucia

Study participating centre

Tropical Medicine Research Institute

Kingston
7
Jamaica

Sponsor information

The University of the West Indies (Jamaica)
University/education

Tropical Medicine Research Institute
The University of the West Indies
Mona
Kingston
7
Jamaica

Email	tmri.eru@uwimona.edu.jm
Website	http://mona.uwi.edu
"ROR"	https://ror.org/03fkc8c64

Funders

Funder type

Research organisation

Inter-American Development Bank (USA) Ref: ATN/SF-12300-RG
Private sector organisation / International organizations

Alternative name(s): Banco Interamericano de Desarrollo, Banco Interamericano de Desenvolvimento, Banque Interaméricaine de Développement, IADB, BID, IDB
Location: United States of America

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	31/10/2017	21/01/2019	Yes	No
Results article	results of integrating a parenting intervention with routine primary health care,	01/08/2015	21/01/2019	Yes	No
Results article	results of the impact, acceptability and costs of delivering parenting interventions through health services in the Caribbean,	01/11/2015	21/01/2019	Yes	No

Editorial Notes

21/01/2019: Publication references added