Plain English Summary
Background and study aims
Research on whether early co-parenting programmes are helpful with parents of temperamentally reactive (difficult to soothe) infants, is an innovative and highly valuable area of study, not only for Malta but also internationally. Besides filling an important and crucial research gap that exists between the co-parenting relationship quality and such infants presenting with a reactive temperament, this research carries strong preventive qualities in terms of risks of development of child psychopathology (such as ADHD, Conduct Disorder, Autistic Spectrum Disorder and other child behavioural difficulties). The programme used in this study, called the Parents As Partners Programme (PasP), an evidence-based parenting programme, is also expected to greatly enhance the quality of relationships in young families who may be experiencing stress and may also be at the brink of breakdown. This becomes all the more threatening with infants that are more challenging to manage. Therefore a research of this quality and nature is important not only for families, but also for children and future society. The aim of this study is to examine if the PasP can enhance parent’s ability to coparent and if it can positively impact children’s behaviour.
Who can participate?
Parents over 18 years of age who have an eight month old infant visiting Well Baby Clinics.
What does the study involve?
Participating parents are randomly allocated to one of two groups. Those in the first group receive care as usual. Those in the second group receive the PasP programme, which helps participants support each other and explore their parenting and relationships for two or three months. Participants receive monthly phone calls to check their progress. All participants complete questionnaires after completing the programme around two or three months and again at six months.
What are the possible benefits and risks of participating?
Participants may benefit from gaining a deeper understanding about their relationship as a couple and as parents, as well as learn more about how they can work together as a team. The risks involved may be connected to areas of conflict that are spoken about within the group, although prior to the commencement of the group, group leaders meet with all participants to evaluate safety.
Where is the study run from?
This study is being run by University of Malta, Department of Family Studies (Malta) and takes place in five health centres in Malta.
Who is funding the study?
1. University of Malta (Malta)
2. HSBC-Malta (Malta)
Who is the main contact?
Ms Ingrid Grech Lanfranco
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PasPgrp
Study information
Scientific title
Does early co-parenting programmes with parents of infants with a highly reactive temperament help? A randomised controlled trail using Parents As Partners
Acronym
Study hypothesis
Research Questions:
1. Does the Parents as Partners coparenting programme, delivered in the early stages following the birth of an infant with a highly reactive temperament enhance the parents' ability to coparent?
2. Does the same programme also positively change the descriptions given by the parents of the child's behaviour connected to temperament?
Ethics approval
University Research Ethics Committee (UREC), 21/03/2017, ref: SWB 220/2016
Study design
Group designed randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Coparenting relationship and child temperament
Intervention
Participants are randomly allocated by a blinded uninvolved person, using participant reference numbers to aviod randomisation bias. Numbers are drawn randomly to either the intervention or the control group respectively.
The intervention consists of the Parents As Partners coparenting programme run by male/female co-facilitating couples. Participants are given the opportunity to explore how their relationship as a couple impacts the way they parent together, and the quality of relationships they each build with their child. They learn about how they support or can improve their support to each other, and how each are effected by their infant and by each other.
Case managers also contact both intervention and control group participants once monthly to check-in.
Provision of supervision to co-facilitating couples throughout programme. Both the intervention and control groups receive a monthly phone-call from their case manager. The phone call only serves as a check-in. All participants fill in the Parenting Stress Index, Coparenting Relationship Scale and the Infant Behaviour Questionnaire before the random allocation.
Both intervention and control groups fill in the Parenting Stress Index, Coparenting Relationship Scale and Early Childhood Behaviour Questionnaire after the completion of the Parents as Partners programme. This happens specifically 2 to-3 months following the completion of the latter programme, and again following a span of 6 months.
The Parents as Partners programme is only offered to the intervention group. Those in the control group receive the usual care.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Parenting stress is measured using Parenting Stress Index-Short Form version 4 at month two and six
2. Co-parenting relationship is measured using the coparenting relationship scale at month two and six
3. Behaviour is measured using the Early Childhood Behaviour Questionnaire at month two and six
Secondary outcome measures
There are no secondary outcome measures.
Overall trial start date
04/11/2015
Overall trial end date
30/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parents of 8 month old infants visiting Well Baby Clinics for 8 month follow-up
2. Maltese speaking
3. Parents over 18 years of age
4. Parenting infant together whether they live in the same household or not
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
It is hoped that a total of 64 participants will be reached, half of which receive the intervention, and half in the control groups.
Total final enrolment
57
Participant exclusion criteria
1. Those parents who are parenting alone
2. Non Maltese-speaking
3. Children over 1 year of age at recruitment stage
Recruitment start date
01/06/2017
Recruitment end date
31/07/2019
Locations
Countries of recruitment
Malta
Trial participating centre
University of Malta, Department of Family Studies
MSD
Malta
Trial participating centre
Mosta Health Centre
Constitution Street
Mosta
MST 9059
Malta
Trial participating centre
Floriana Health Centre
F.S. Fenech Street
Floriana
FRN 1211
Malta
Trial participating centre
Paola Health Centre
Antoine De Paule Square
Paola
PLA 1266
Malta
Trial participating centre
Rabat Health Centre
Civic Centre
St. Kataldu Street
Rabat
RBT 1528
Malta
Trial participating centre
Qormi Health Centre
Victory Road
Qormi
QRM 2503
United Kingdom
Funders
Funder type
University/education
Funder name
University of Malta
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
HSBC - Malta
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plans to finalise PhD in 2020, after which I hope to publish this study, ideally in a high-impact peer reviewed journal, or a parenting journal. I hope to be able to publish more than one article, together with my tutors as co-authors. The study protocal, and a statistical analysis will be available on completion of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact that the participants gave consent only to have data shared with the investigator and her team. Means and standard deviations for each measure will be included in the publication of the results.
Intention to publish date
31/12/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list