Condition category
Mental and Behavioural Disorders
Date applied
26/11/2015
Date assigned
27/11/2015
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is generally considered that the early experiences of children help to shape their development. There is a lot of evidence that suggests that early parenting interventions (programmes) can significantly enhance parenting skills, as well as parent-child relationships and child wellbeing. Parents with children under the age of three may be the best targets for parenting programmes, as children are thought to be particularly receptive during this stage of their development. The Parent and Infant (PIN) Programme is an early parenting intervention which includes a range support for parents, including the Incredible Years programme (a well-established parenting programme designed to strengthen the relationships between parent and child), weaning and healthy eating workshops, first aid and support with language development. The aim of this study is to look at the effectiveness, implementation and cost effectiveness of the PIN programme.

Who can participate?
Parents aged 16 or over who live in areas where the PIN programme is available.

What does the study involve?
Participants are recruited into two different study groups. In the first group, parents take part in the PIN programme. In the second group, parents receive the usual care provided by their local health service. Parents will be asked to fill in a number of questionnaires at the start of the study, and then again at follow-up appointments when their babies are 8, 16 and 24 months old. The way the participants interact with their babies is also observed at these times in order to assess parent-infant relationships.

What are the possible benefits and risks of participating?
Participants may benefit from learning better parenting skills as well as strengthened relationships with their children. Additionally, taking part in the PIN programme could reduce the risk of the participants’ children developing behavioural problems as they get older. There are no notable risks of taking part in the study.

Where is the study run from?
A number of public health and community-based services in Dublin West and Dundalk/Drogheda in County Louth (Republic of Ireland)

When is the study starting and how long is it expected to run for?
May 2014 to December 2018

Who is funding the study?
Health Research Board (Ireland)

Who is the main contact?
1. Dr Sinead McGilloway (Scientific)
sinead.mcgilloway@nuim.ie
2. Dr Grainne Hickey (Public)
grainne.nimhaille@gmail.com

Trial website

www.enrichireland.com

Contact information

Type

Scientific

Primary contact

Dr Sinead McGilloway

ORCID ID

Contact details

Mental Health and Social Research Unit
Maynooth University Department of Psychology
John Hume Building
North Campus
National University of Ireland Maynooth
Maynooth
W23 F2H6
Ireland
+353 1 708 6052
sinead.mcgilloway@nuim.ie

Type

Public

Additional contact

Dr Grainne Hickey

ORCID ID

Contact details

Mental Health and Social Research Unit
Maynooth University Department of Psychology
John Hume Building
North Campus
National University of Ireland Maynooth
Maynooth
W23 F2H6
Ireland
+353 1 708 6658
grainne.nimhaille@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A controlled trial, cost-effectiveness and process evaluation of a group-based early parenting intervention to improve parental competence and infant wellbeing for parents and infants (aged 0-2)

Acronym

Study hypothesis

The aim of this study is to assess the effectiveness, implementation and cost-effectiveness of a group-based early parenting intervention – the Parent and Infant (PIN) programme.

Main research questions:
1. Does the PIN programme improve parent and infant outcomes?
2. What resources are involved in programme implementation and how do key stakeholders respond to the intervention?
3. How cost-effective is the intervention when compared with usual services?

Ethics approval

1. Maynooth University Social Research Ethics Sub-Committee, 14/11/2014, ref: SRESC-2014-060
2. The HSE North East Area Research Ethics Committee, 05/08/2015

Study design

Multi-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Emotional and behavioural difficulties (EBD)

Intervention

Two groups will be recruited to take part in the research:

Group 1: A treatment or intervention group comprising parents and infants who participate in the Parent and Infant (PIN) programme. The PIN programme is a group-based early parenting intervention, which combines a range of developmentally-appropriate parent and infant supports which are delivered in a single intervention process from birth to two years of age. Parents who have recently given birth are offered a 16-week Incredible Years Parent and Baby (IY-PBP) program straddling the first six months of development. During this period, the IY program is delivered on alternate weeks in conjunction with information and awareness-raising and practical workshops and classes for new mothers (e.g. baby massage classes, weaning workshops, paediatric first aid, dental health and child safety). Tailor-made play workshops, as well as oral language development supports are also offered to parents when the infant is between the 8-12 months old. Subsequently, when the child reaches 18 months, the Incredible Years Parent and Toddler Program (IY-PTP) will be delivered. The programme is rooted in the principles of wraparound intervention and multidisciplinary, community based care, whilst the programme sub-components, particularly the Incredible Years programmes, draw on the principles of behavioural and social learning theory.

Group : A comparison/control group comprising parents and infants who receive “services as usual” (SAU). Usual services for parent-infant dyads involve: one home visit from a PHN in the first six weeks after birth and regular developmental check-ups with a GP/PHN.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Parental satisfaction and self-efficacy are measured using the Parental Sense of Competence (PSOC) scale at baseline and at follow-ups when the infant is 8-months old, 16-months old and 24 months old.

Secondary outcome measures

1. Parental wellbeing is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at follow-ups when the infant is 8-months old, 16-months old and 24 months old
2. Parent and infant relationships are measured using the Maternal Postnatal Attachment Scale - Quality of Attachment Subscale (MPAS) at baseline and at follow-ups when the infant is 8-months old, 16-months old and 24 months old
3. Child development and socioemotional adjustment is measured using the Ages and Stages Questionnaire-3 (ASQ-3) and the Ages and Stages Questionnaire: Social and Emotional (ASQ: SE) parent-report tools at baseline and at follow-ups when the infant is 8-months old, 16-months old and 24 months old.
4. Infant temperament is measured using the Infant Characteristic Questionnaire – fussy-difficult Subscale (ICQ) at baseline and at follow-ups when the infant is 8-months old, 16-months old and 24 months old
5. Cognitive stimulation and emotional support is measured using the Infant and Toddler Home Observation for Measurement of the Environment – Short Form (HOME-SF). The HOME-SF will be completed by researchers observing the home environment and parent-infant interactions at baseline and at follow-ups when the infant is 8, 16 and 24 months old.

Overall trial start date

01/05/2014

Overall trial end date

21/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents are aged 16 years or older
2. Parents are willing and able to participate in the programme and/or are willing and able to participate in the research
3. Parents are living in the target research areas
4. Parents must have a very good working knowledge of English

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Parents are younger than 15 years of age
2. Parents are unwilling to take part in the research
3. Parents do not live in the target research areas
4. Parents do not have a good working knowledge of English

Recruitment start date

01/08/2014

Recruitment end date

01/06/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

The Blue Skies Initiative
Unit 2B Nangor Road Business Park Nangor Road
Dublin
D12
Ireland

Trial participating centre

The Genesis Programme
Chester House Fair Green
Drogheda
Co. Louth
Ireland

Trial participating centre

Dublin West Public Health Nursing Service
Cherry Orchard Hospital Ballyfermot
Dublin
Dublin 10

Trial participating centre

Louth Public Health Nursing Service
Louth PCC Dublin Road
Dundalk
Co. Louth
Ireland

Sponsor information

Organisation

National University of Ireland Maynooth

Sponsor details

National University of Ireland Maynooth
Co. Kildare
Maynooth
W23 F2H6
Ireland

Sponsor type

University/education

Website

www.maynoothuniversity.ie

Funders

Funder type

Government

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publication of reports and journal articles of short- and long-term results from mid-2016 up until and beyond the end of funding in December 2018. These publications will include results from the controlled trial, the cost-effectiveness analysis and the process evaluation. Our reports (and journal articles) will be disseminated to participating services, as well as to other relevant agencies nationally and internationally. We will also attend conferences both nationally and internationally and publicise the findings through national media.

Intention to publish date

01/09/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes