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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 18, 2019, 10:50 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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

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Intervention

Is the intervention completed?
No
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, Papers & Other Materials

Relevant Paper(s)

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

Reports & Other Materials