Condition category
Mental and Behavioural Disorders
Date applied
11/09/2017
Date assigned
25/09/2017
Last edited
20/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Clincis.

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

Contact information

Type

Public

Primary contact

Ms Ingrid Grech Lanfranco

ORCID ID

Contact details

University of Malta
No. 4
Wakefield
Triq F.X. Ebejer
Ta' L-Ibragg
Swieqi
SWQ2172
Malta

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 measures

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

31/07/2019

Reason abandoned

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.

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

Sponsor information

Organisation

University of Malta

Sponsor details

Tal-Qroqq
Msida
MSD
Malta

Sponsor type

University/education

Website

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 current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes