Condition category
Not Applicable
Date applied
07/06/2013
Date assigned
20/06/2013
Last edited
25/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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. To determine if the effects of the programme are sustained later in childhood, data are collected from the high and low treatment groups at 7-11 years (age 9 on average) 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 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.
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 study is funded by the Northside Partnership through the Department of Children and Youth Affairs, Ireland and the Atlantic Philanthropies (USA)
The follow-up study at about age 9 is funded by the Northside Partnership

Who is the main contact?
Dr Orla Doyle
orla.doyle@ucd.ie

Trial website

http://geary.ucd.ie/preparingforlife/

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.

Added 24/01/2019:
For the Age 9 follow-up study it is hypothesised that children who participated in the Preparing for Life Programme will have significantly better child health and development outcomes than those in the control group.

The null hypothesis for the follow-up study is that there will be no difference in children’s health and development outcomes between treatment groups; this may arise if the impacts of the intervention are not sustained.

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

Follow-up study:
1. UCD Human Research Ethics Committee, 11/12/2018, ref: HS-18-90-Doyle

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 measure

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 months)
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)
4. 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)

Added 24/01/2019:
Age 9 follow-up study, Child Health and Development Outcomes (~age 9)
1. Cognitive development measured using British Ability Scales; Executive functions NIH Toolbox measures: Flanker task, dimensional change card sort task, & list sorting task
2. Physical health and motor skills: parent-reported child health, measured height & weight, Harvard step-test
3. Socio-emotional development measured using parent-report Brief Problems Monitor, Strengths and Difficulties Questionnaire, and child self-report of problem behaviours using Social Skills Improvement System
5. School attendance and performance measured using standardised test score data from primary schools (SIGMA/MICRA-T or Drumcondra tests), school attendance records, and resource supports
6. Differential susceptibility measured using DNA sampling through non-invasive saliva swab procedure

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)

Added 24/01/2019:
Age 9 follow-up study (~age 9)
1. Quality of the home environment measured using Family Involvement Questionnaire
2. Parental attention measured using Attentional Control Scale

Overall trial start date

31/07/2008

Overall trial end date

01/10/2019

Reason abandoned (if study stopped)

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

http://www.ucd.ie/

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

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository. Participant level data for the evaluation to date from 2008-2015 is already available in the Irish Social Science Data Archive (https://www.ucd.ie/issda/data/pfl/). Consent to anonymise the 2008-2015 data was sought on recruitment into the PFL programme and evaluation. For the age 9 follow-up study, participant level data will also be archived within the Irish Social Science Data Archive once the study is complete. The will be available for research purposes through the ISSDA application process. Consent to anonymise and archive the data is sought from participants when they are asked to take part in the Age 9 follow-up study.

Intention to publish date

Participant level data

Stored in repository

Basic results (scientific)

Publication list

1. 2012 protocol in: http://www.tara.tcd.ie/handle/2262/66022
2. 2013-2016 results in: http://geary.ucd.ie/preparingforlife/?page_id=146
3. 2014 perinatal results in: http://www.ncbi.nlm.nih.gov/pubmed/25027267
4. 2014 analysis of programme engagement in: https://doi.org/10.1002/jcop.21592
5. 2015 child health results in: https://www.ncbi.nlm.nih.gov/pubmed/26439756
6. 2016 socioemotional results in: http://www.ncbi.nlm.nih.gov/pubmed/27253184
7. 2016 resilience and children’s perspectives in: https://doi.org/10.1177/0143034315613777
8. 2016 process evaluation in: https://doi.org/10.1285/i24212113v2i1p52
9. 2010 children’s perspectives on toileting in: https://www.ncbi.nlm.nih.gov/pubmed/27177551
10. 2017 dietary intake results in: https://www.ncbi.nlm.nih.gov/pubmed/27451920
11. 2017 early life outcomes in: https://doi.org/10.1016/j.labeco.2016.11.002
12. 2017 children’s perspectives school experiences in: https://doi.org/10.1080/1350293X.2017.1288386
13. 2017 maternal warmth and toddler development in: https://www.ncbi.nlm.nih.gov/pubmed/27771763
14. 2017 well-being results in: https://www.ncbi.nlm.nih.gov/pubmed/28095505
15. 2017 archiving results in: https://childrensresearchnetwork.org/knowledge/resources/archiving-the-preparing-for-life-data
16. 2017 cognitive and socioemotional results in: https://researchrepository.ucd.ie/handle/10197/8732
17. 2018 shared book reading results in: https://doi.org/10.1016/j.appdev.2017.12.001
18. 2018 behaviour, cognition, and health results in: https://www.ncbi.nlm.nih.gov/pubmed/29703802

Publication citations

Additional files

Editorial Notes

25/01/2019: IPD sharing statement added. 24/01/2019: The following changes were made to the trial record: 1. The study hypothesis, ethics approval, and primary and secondary outcome measures fields were updated to include the age 9 follow-up study. 2. The overall trial end date was changed from 30/03/2015 to 01/10/2019. 3. Publication references added. 03/06/2016: Publication reference added.