Plain English Summary
Background and study aims
This study is to test the effectiveness of the Preparing for Life (PFL) 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 PFL programme, which began in 2008, works with families right from pregnancy until school entry in order to promote positive child development through improved parental behaviour and social support.
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 January 2008 and August 2010.
What does the study involve?
On recruitment during pregnancy, participants were randomly assigned to either a low treatment group or a high treatment group. In addition, 99 pregnant women were recruited into a comparison group from comparable community. 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. The aim of the home visit is to support and help the parents with key parenting issues. Secondly, participants in the high treatment group also participate in the Triple P Positive Parenting Programme which aims to improve positive parenting in a group-based setting for eight consecutive weeks. Data collected 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) are compared.
What are the possible benefits and risks of participating?
If the programme is effective, families in the high treatment group may benefit 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 discomfort or stress to the participant.
Where is the study run from?
The study is run from the Geary Institute at the University College Dublin, Ireland.
When is the 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.
Who is funding the study?
The study is funded by the Northside Partnership through the Department of Children and Youth Affairs, Ireland and the Atlantic Philanthropies (USA).
Who is the main contact?
Dr Orla Doyle
orla.doyle@ucd.ie
Trial website
Contact information
Type
Scientific
Primary contact
Dr Orla Doyle
ORCID ID
Contact details
UCD Geary Institute & School of Economics
University College Dublin
Belfield
Dublin
4
Ireland
+353 (0)1716 4637
orla.doyle@ucd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial to determine the effectiveness of the Preparing For Life programme which aims to improve the school readiness skills of socioeconomically disadvantaged children in Dublin, Ireland
Acronym
PFL
Study hypothesis
It is hypothesised that the children participating in Preparing for Life Programme will be significantly better prepared for school than those in the control group.
The null hypothesis is that there will be no difference in school readiness between treatment groups; this may arise if the intervention is not effective or if there is contamination between groups.
Ethics approval
1. UCD Human Research Ethics Committee, 08/05/2008, ref: HS-07-26-Harmon-Doyle
2. The Rotunda Hospital Ethic Committee, 12/05/2008
3. National Maternity Hospital ethic committee 28/07/2008
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Patient information can be found at http://www.preparingforlife.ie/parents-resources/participants-information
Condition
School readiness
Intervention
On recruitment during pregnancy, participants were randomly assigned to either a low treatment group or a high treatment group. High and low treatment groups receive 100 worth of developmental toys annually and facilitated access to one year of high quality preschool. High treatment group receive two additional services. First, participants in the high treatment group receive a home-visiting mentoring support service starting during pregnancy and continuing until the children start school at age 4/5. Secondly, participants in the high treatment group participate in group parent training when the target child is 3 years old.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
School Readiness Skills
1. Cognitive development: measured using Ages and Stages Questionnaire (at 6, 12, 18, 24, 36, 48 months); Developmental Profile 3 (at 12, 18, 24, 36, 48); British Ability Scales (at 48 months); Executive functioning & delay of gratification (48 months).
2. Physical health and motor skills: measured using Ages and Stages Questionnaire (at 6, 12, 18, 24, 36, 48 months); hospital records (at 48 months); parent-reported child health (at 6, 12, 18, 24, 36, 48).
3. Socio-emotional development: measured using Temperament and Atypical Behaviour Scale (at 12 months); Difficult temperament (at 6 & 12 months); ASQ-Socio-Emotional scale (at 6, 12, 18, 24, 36, 48 months); Brief Infant Toddler 4. Social and Emotional Assessment (at 12, 18 24, 36 months).
Behavioural skills: measured using Temperament and Atypical Behaviour Scale (at 12 months); Child Behaviour Checklist (at 18, 36, 48 months); Peer Problems and Prosocial Behaviour (at 48 months),
5. Language development and emergent literacy: measured using Mac-Arthur Bates Communicative Development Inventories (at 12, 18, 24 months); Ages and Stages Questionnaire (at 6, 12, 18, 24, 36, 48 months); British Ability Scales (at 48 months).
Secondary outcome measures
1. Birth outcomes: maternity hospital records at birth (birth weight, gestational age, prematurity, Apgar score)
2. Labour outcomes: maternity hospital records at birth (instrumental delivery, caesarean section- elective, emergency
3. Parenting skills: Adult Adolescence Parenting Inventory (at baseline &12 months); Knowledge of Infant Development (at baseline & 12 months); Parental locus of control (at 6 months); Condon Maternal Attachment Scale (at 6 & 24 months); Parenting Stress Index (at 6, 24 & 48 months); Parenting Daily Hassles Scale (at 18, 36 & 48 months).; Maternal Separation Anxiety (at 18 months); Parental Cognitions and Conduct Towards Infant Scale (at 6 & 24 months); Parenting Styles and Dimensions Questionnaire (at 36 & 48 months); Parental Acceptance -Rejection Questionnaire (at 36 months).
4. Quality of the home environment: Home Observation for Measurement of the Environment scale (at 6, 18 & 36 months); Activities with child (at 6, 18, 36 months); Home Learning Environment (at 48 months); Material Deprivation scale (at 18 months); Framingham Safety Survey (at 6, 18, & 48 months); Family Environment Scale (at 12 &36 months); Difficult Life Circumstances (18 & 36 months); Neighbourhood Quality Evaluation Scale (at 36 months); Family Routine Inventory (at 36 months).
5. Parent health: physical health outcomes (self-reported) (at baseline, 6, 12, 18, 24, 36, 48 months); personality (Tem-Item Personality Inventory (baseline), Rosenberg self-esteem (at baseline12, 18, 48 months) Pearlin Self-Efficacy Scale (at baseline,12 & 48 months) ; Vulnerable Attachment Style Questionnaire (baseline); Considerations of Future Consequences (at baseline & 24 months); Future Outlook Inventory (at 12, 36 months); Self-control (at 18 months);
mental health outcomes (Edinburgh Postnatal Depression Scale at 6, 18, 24, 36, & 48); WHO-5 Index (at baseline, 6, 12, 36, 48)
6. Social support and service use: Level from support from various people (at 6, 18, 24, 36, & 48 months); community integration (at 6, 12, 18, 24, 36, 48 months); use of services (at 6, 18, 36 months); partner satisfaction (at 6, 12, 24, 48 months); Maternal Social Support Index ( at 18 & 36 month); Family Quality of Life (at 36 months); Relationship Quality Index (at 36 months).
Overall trial start date
31/07/2008
Overall trial end date
30/03/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women (age 16+) pregnant between 2008 and 2010
2. Residing in the PFL catchment area
3. Willing to be assigned to either of the study intervention groups
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
Potential participants were excluded if they did not meet inclusion criteria
Recruitment start date
31/07/2008
Recruitment end date
30/03/2015
Locations
Countries of recruitment
Ireland
Trial participating centre
University College Dublin
Dublin
4
Ireland
Sponsor information
Organisation
University College Dublin (Ireland)
Sponsor details
Belfield
Dublin
4
Ireland
+353 (0)1716 4615
geary@ucd.ie
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Northside Partnership through the Department of Children and Youth Affairs and The Atlantic Philanthropies (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 protocol in:
Doyle, O. Breaking the Cycle of Deprivation: An Experimental Evaluation of an Early Childhood Intervention. Journal of the Statistical and Social Inquiry Society of Ireland, Vol. XLI, 92-111.
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25027267
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27253184
Publication citations
-
Results
Doyle O, McGlanaghy E, Palamaro-Munsell E, McAuliffe FM, Home based educational intervention to improve perinatal outcomes for a disadvantaged community: A randomised control trial., Eur. J. Obstet. Gynecol. Reprod. Biol., 2014, 180, 162-167, doi: 10.1016/j.ejogrb.2014.06.006.
-
Results
Doyle O, McGlanaghy E, O'Farrelly C, Tremblay RE, Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials, PLoS One, 2016 , 11, 6, e0156397, doi: 10.1371/journal.pone.0156397.