Parents As Partners coparenting programme with parents of infants who are more challenging to soothe
| ISRCTN | ISRCTN55209338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55209338 |
| Protocol serial number | PasPgrp |
| Sponsor | University of Malta |
| Funders | University of Malta, HSBC - Malta |
- Submission date
- 11/09/2017
- Registration date
- 25/09/2017
- Last edited
- 09/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
University of Malta
No. 4, Wakefield
Triq F.X. Ebejer
Ta' L-Ibragg
Swieqi
SWQ2172
Malta
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Group designed randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | University Research Ethics Committee (UREC), 21/03/2017, ref: SWB 220/2016 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Parenting stress is measured using Parenting Stress Index-Short Form version 4 at month two and six |
| Key secondary outcome measure(s) |
There are no secondary outcome measures. |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Total final enrolment | 57 |
| Key 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 |
| Key exclusion criteria | 1. Those parents who are parenting alone 2. Non Maltese-speaking 3. Children over 1 year of age at recruitment stage |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 31/07/2019 |
Locations
Countries of recruitment
- United Kingdom
- Malta
Study participating centres
Malta
Mosta
MST 9059
Malta
Floriana
FRN 1211
Malta
Paola
PLA 1266
Malta
St. Kataldu Street
Rabat
RBT 1528
Malta
Qormi
QRM 2503
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 14/12/2020 | 14/12/2020 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Thesis results | 09/08/2022 | No | No |
Additional files
- ISRCTN55209338_BasicResults_14Dec2020.pdf
- Uploaded 14/12/2020
Editorial Notes
09/08/2022: Thesis reference added.
14/12/2020: The basic results of this trial have been uploaded as an additional file.
03/09/2019: IPD sharing statement added.
14/08/2019: Total final enrolment number added, overall trial end date changed from 31/07/2019 to 30/09/2019.
