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The Evaluation of the Preparing for Life Early Childhood Intervention Programme
Last registered on January 23, 2019

Pre-Trial

Trial Information
General Information
Title
The Evaluation of the Preparing for Life Early Childhood Intervention Programme
RCT ID
AEARCTR-0000066
Initial registration date
September 02, 2013
Last updated
January 23, 2019 5:21 AM EST
Location(s)

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Primary Investigator
Affiliation
University College Dublin
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2008-05-31
End date
2019-10-01
Secondary IDs
Abstract
Background and study aims

This study is a randomised control trial (RCT) evaluation of a preventative programme which aims to improve school readiness and life outcomes of socioeconomically disadvantaged children. The programme is operating in several disadvantaged communities in Dublin with above national average rates of unemployment, early school leavers, lone parent households and social housing. The Preparing for Life (PFL) programme, which began in 2008, works with families from pregnancy until school entry in order to promote positive child development through improved parental behaviour and social support.

The programme is being evaluated using a mixed methods approach, incorporating a longitudinal experimental design and implementation analysis. The experimental component involves the random allocation of participants from the PFL communities to either the low or high treatment group for the duration of the programme.

Who can participate?
All pregnant women from the target communities in Dublin were eligible to participate. 233 pregnant were recruited into the PFL Programme between 2008 and 2010. Randomisation resulted in 115 participants assigned to the high treatment group and 118 participants assigned to the low treatment group. In addition, 99 pregnant women were recruited into a comparison group from comparable community. The population based recruitment rate was 52%.

What does the study involve?
Preparing for Life provides a range of supports to participating families from pregnancy until school entry. The programme targets a range of child outcomes which are related to school readiness, including cognitive development, physical health and motor skills, socio-emotional development, behavioural skills, language development and emergent literacy.

On recruitment during pregnancy, participants are randomly assigned to either a low treatment group or a high treatment group. Both the high and low treatment groups receive €100 worth of developmental toys annually and facilitated access to one year of high quality preschool. In addition, the high treatment group receive two additional supports that are not available to the low treatment group. First, participants in the high treatment group receive a home-visiting mentoring support service. The aim of the home visits is to support and help the parents with key parenting issues. Secondly, participants in the high treatment group also participate in group parent training using the Triple P Positive Parenting Programme which aims to improve positive parenting in a group-based setting for eight consecutive weeks.

The evaluation collects data from all three groups (high treatment, low treatment, comparison group) at baseline during pregnancy (t0), and when the child is six months (t1), 12 months (t2), 18 months (t3), 24 months (t4), three years (t5), and four years old (t6). A comprehensive set of data are collected at each point. At each time point, we compare the outcomes of the high treatment group, low treatment and comparison groups.

To determine if the effects of the programme are sustained later in childhood, data collected from high and low treatment groups at 7-11 years (age 9 on average are collected and compared as part of a follow-up study

What are the possible benefits and risks of participating?
If the programme is effective, families in the high treatment group may benefit from the programme by gaining greater parenting knowledge and skills; and their children will be better prepared for school.

Risks of participation are few. The main risk is that some study questions are of a personal nature and may cause participant discomfort or stress. Potential participants are informed as part of the consent process that participation is voluntary and that they can withdraw from the study or decline to answer any question at any time without penalty.

Where is the study run from?
The Evaluation of PFL is housed at the Geary Institute at University College Dublin in Dublin Ireland.

When is study starting and how long is it expected to run for?
Recruitment took place from 2008 to 2010. The evaluation continues until all children are 4 years of age, in March 2015.

A follow-up study from January 2019 to September 2019 examines the impact of receiving the PFL programme between the ages of 0 and 5 on children's outcomes later in childhood (approximately age 9).

Who is funding the study?
The evaluation of the Preparing for Life programme is funded by the Northside Partnership through the Department of Children and Youth Affairs and The Atlantic Philanthropies.

The follow-up study at ~age 9 is funded by the Northside Partnership

Who is the main contact?
Dr. Orla Doyle, [email protected]
External Link(s)
Registration Citation
Citation
Doyle, Orla. 2019. "The Evaluation of the Preparing for Life Early Childhood Intervention Programme." AEA RCT Registry. January 23. https://doi.org/10.1257/rct.66-2.0.
Former Citation
Doyle, Orla. 2019. "The Evaluation of the Preparing for Life Early Childhood Intervention Programme." AEA RCT Registry. January 23. https://www.socialscienceregistry.org/trials/66/history/40510.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The Preparing for Life (PFL) programme works with families from pregnancy until school entry in order to promote positive child development through improved parental behaviour and social support. Preparing for Life provides a range of supports to participating families from pregnancy until school entry. The programme targets a range of child outcomes which are related to school readiness, including cognitive development, physical health and motor skills, socio-emotional development, behavioural skills, language development and emergent literacy.

On recruitment during pregnancy, participants are randomly assigned to either a low treatment group or a high treatment group. Both the high and low treatment groups receive €100 worth of developmental toys annually and facilitated access to one year of high quality preschool. In addition, the high treatment group receive two additional supports that are not available to the low treatment group. First, participants in the high treatment group receive a home-visiting mentoring support service. The aim of the home visits is to support and help the parents with key parenting issues. Secondly, participants in the high treatment group also participate in group parent training using the Triple P Positive Parenting Programme which aims to improve positive parenting in a group-based setting for eight consecutive weeks.
Intervention Start Date
2008-05-31
Intervention End Date
2015-03-31
Primary Outcomes
Primary Outcomes (end points)
School Readiness Skills (cognitive development, physical health and motor skills, socio-emotional development, behavioural skills, language development and emergent literacy)

Age 9 follow-up study, child health and development outcomes (~age9): cognitive development, physical health and motor skills, socioemotional development, school attendance and performance, differential susceptibility.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
On recruitment during pregnancy, participants are randomly assigned to either a low treatment group or a high treatment group. Both the high and low treatment groups receive €100 worth of developmental toys annually and facilitated access to one year of high quality preschool. In addition, the high treatment group receive two additional supports that are not available to the low treatment group. First, participants in the high treatment group receive a home-visiting mentoring support service. The aim of the home visits is to support and help the parents with key parenting issues. Secondly, participants in the high treatment group also participate in group parent training using the Triple P Positive Parenting Programme which aims to improve positive parenting in a group-based setting for eight consecutive weeks.
Experimental Design Details
Not available
Randomization Method
PFL participants were randomised after informed consent was obtained. To ensure randomisation was not compromised an unconditional probability computerised randomisation procedure was used whereby the participant pressed a key on a computer which randomly allocated her treatment group assignment. Once assignment was completed, an automatic email was generated which included the participant’s unique ID number and assignment condition. This email was automatically sent to the PFL programme manager and the evaluation manager. This method was used to ensure that the recruiter had no influence on the treatment assignment. Thus if any attempts to reassign participants from one group to another group, by either directly changing the database or repeating the randomisation procedure, a second email would be generated to automatically highlight this intentional subversion.
Randomization Unit
Individual level
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
1
Sample size: planned number of observations
233
Sample size (or number of clusters) by treatment arms
115 treatment participants and 118 control participants
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University College Dublin Human Research Ethics Committee
IRB Approval Date
2018-12-11
IRB Approval Number
HS-18-90-Doyle
IRB Name
University College Dublin Human Research Ethics Committee
IRB Approval Date
2008-05-08
IRB Approval Number
HS-07-26-Harmon-Doyle