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Delivering parenting interventions through health services in the Caribbean
Last registered on October 18, 2019

Pre-Trial

Trial Information
General Information
Title
Delivering parenting interventions through health services in the Caribbean
RCT ID
AEARCTR-0004833
Initial registration date
October 17, 2019
Last updated
October 18, 2019 10:50 AM EDT
Location(s)
Region
Region
Primary Investigator
Affiliation
Inter-American Development Bank
Other Primary Investigator(s)
PI Affiliation
The University of the West Indies
PI Affiliation
The University of the West Indies
PI Affiliation
The University of the West Indies
Additional Trial Information
Status
Completed
Start date
2011-08-01
End date
2017-11-01
Secondary IDs
Abstract
Integrating early childhood interventions with health and nutrition services has been recommended, however there is limited information on interventions that are effective and feasible for delivery through health services. In this trial we developed and evaluated a parenting program that could be integrated into primary health center visits. The intervention used group delivery at five routine visits from age 3-18 months, and comprised: short films of child development messages, shown in the waiting area; discussion and demonstration led by community health workers; and mothers’ practice of activities. Nurses gave out and reviewed message cards with mothers, together with a few play materials. A cluster randomized trial was conducted in the Caribbean (Jamaica, Antigua and St Lucia) in 29 health centers (HC). Centers, stratified by the 3 countries, were randomized to control (n=15) or health center intervention (n=14). We also adapted the Jamaica home visit intervention to increase feasibility at scale, and evaluated this together with the group intervention in Jamaica only (5 additional HC in home intervention and 5 additional HC in both intervention group). Participants were recruited at the 6-8 week child health visit.
External Link(s)
Registration Citation
Citation
Chang-Lopez, Susan et al. 2019. "Delivering parenting interventions through health services in the Caribbean." AEA RCT Registry. October 18. https://doi.org/10.1257/rct.4833-1.0.
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2011-11-01
Intervention End Date
2013-06-01
Primary Outcomes
Primary Outcomes (end points)
The Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) (Wechsler 2012); The Strengths and Difficulties questionnaire (Goodman 1997); Daberon 2 (Danzer et al. 1991); Height and weight
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
The Middle Childhood Home Observation for Measurement of the Environment (HOME) (Caldwell and Bradley 2003); CES-Depression scale (Radloff 1977); Parent involvement and investment in their child; Parent self-efficacy
Secondary Outcomes (explanation)
For parent involvement and investment in their child measure items were taken or adapted from the following three scales: Parent Involvement in Children’s Education Scale (McWayne, Hampton, Fantuzzo, Cohen & Sekino, 2004); Parental Involvement in Children’s Literacy Development (Enemuo & Obidike, 2013); and Family Involvement Questionnaire (Fantuzzo, Wayne, Perry & Child, 2004). Parent self-efficacy measure corresponds to the Brief Parental Self Efficacy Scale.
Experimental Design
Experimental Design
In Antigua, Jamaica and Saint Lucia government health centers provide free maternal and child health services. These primary health centers serve predominantly lower and lower-middle income groups and are available in all parishes/regions.

Firstly, parishes/regions were selected based on logistical reasons (e.g. distance, number of centers). All 10 centers in the selected regions were included in Antigua and Saint Lucia. In Jamaica 4 eligible centers in the selected parish were excluded for logistical and security reasons and the remaining 20 centers randomized. Health centers were randomly assigned to the treatment group and to the control group. In Jamaica, where the home visiting program was also evaluated, health centers were assigned to one of the four groups (treatment 1- health center intervention-, treatment 2- home visiting intervention-, treatment 3 -both interventions-, or control).
Experimental Design Details
Randomization Method
In office by computer by independent statistician.
Randomization Unit
Randomization was done at public health center level.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
40 health centers
Sample size: planned number of observations
600 children
Sample size (or number of clusters) by treatment arms
15 health centers to control group, 14 health centers to health center only intervention group, 5 health centers to home visiting only intervention group, and 5 health centers to home visiting and health center intervention group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Accounting for sample design and clustering (with an intracluster correlation of 0.03) we have 80% power to detect an effect size of 0.375 SDs
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University Hospital of the West Indies/ University of the West Indies/ Faculty of Medical Sciences Ethics Committee
IRB Approval Date
2011-01-20
IRB Approval Number
ECP 18, 10/11
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Yes
Data Collection Completion Date
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
No
Reports and Papers
Preliminary Reports
Relevant Papers
Abstract
OBJECTIVE: More than 200 million children globally do not attain their developmental potential.
We hypothesized that a parent training program could be integrated into primary health
center visits and benefit child development.
METHODS: We conducted a cluster randomized trial in the Caribbean (Jamaica, Antigua, and St Lucia).
Fifteen centers were randomly assigned to the control (n = 250 mother-child pairs) and 14 to the
intervention (n = 251 mother-child pairs) groups. Participants were recruited at the 6- to 8-week
child health visit. The intervention used group delivery at 5 routine visits from age 3 to 18 months
and comprised short films of child development messages, which were shown in the waiting area;
discussion and demonstration led by community health workers; and mothers’ practice of
activities. Nurses distributed message cards and a few play materials. Primary outcomes were
child cognition, language, and hand-eye coordination and secondary outcomes were caregiver
knowledge, practices, maternal depression, and child growth, measured after the 18-month visit.
RESULTS: Eight-five percent of enrolled children were tested (control = 210, intervention = 216).
Loss did not differ by group. Multilevel analyses showed significant benefits for cognitive
development (3.09 points; 95% confidence interval: 1.31 to 4.87 points; effect size: 0.3 SDs).
There were no other child benefits. There was a significant benefit to parenting knowledge
(treatment effect: 1.59; 95% confidence interval: 1.01 to 2.17; effect size: 0.4).
CONCLUSIONS: An innovative parenting intervention, requiring no additional clinic staff or mothers’
time, was integrated into health services, with benefits to child cognitive development and parent
knowledge. This is a promising strategy that merits further evaluation at scale.
Citation
Chang, S.M., Grantham-McGregor, S.M., Powell, C.A., Vera-Hernández, M., Lopez-Boo, F., Baker-Henningham, H. & Walker, S.P. 2015. Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial. Pediatrics, 136(2), 272