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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: University of Malta
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.
Secondary ID(s)
PasPgrp
Source(s) of Monetary Support
University of Malta, HSBC - Malta
Secondary Sponsor(s)
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:
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