Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
22 August 2022 |
Main ID: |
ISRCTN55209338 |
Date of registration:
|
25/09/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Parents As Partners coparenting programme with parents of infants who are more challenging to soothe
|
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 |
Date of first enrolment:
|
01/06/2017 |
Target sample size:
|
64 |
Recruitment status: |
Completed |
URL:
|
https://www.isrctn.com/ISRCTN55209338 |
Study type:
|
Interventional |
Study design:
|
Group designed randomised controlled trial (Prevention)
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Malta
|
United Kingdom
| | | | | | |
Contacts
|
Name:
|
Ingrid
Grech Lanfranco |
Address:
|
University of Malta
No. 4, Wakefield
Triq F.X. Ebejer
Ta' L-Ibragg
SWQ2172
Swieqi
Malta |
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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
Exclusion criteria: 1. Those parents who are parenting alone 2. Non Maltese-speaking 3. Children over 1 year of age at recruitment stage
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Coparenting relationship and child temperament Mental and Behavioural Disorders Coparenting relationship and child temperament
|
Intervention(s)
|
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.
|
Primary Outcome(s)
|
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(s)
|
There are no secondary outcome measures.
|
Source(s) of Monetary Support
|
University of Malta, HSBC - Malta
|
Ethics review
|
Status:
Approval date:
Contact:
University Research Ethics Committee (UREC), 21/03/2017, ref: SWB 220/2016
|
Results
|
Results available:
|
Yes |
Date Posted:
|
|
Date Completed:
|
30/09/2019 |
URL:
|
|
|
|