Condition category
Mental and Behavioural Disorders
Date applied
19/11/2018
Date assigned
05/02/2019
Last edited
05/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Children of parents with mental health difficulties are at increased risk of having problems with mental health, social status, physical health and educational results. They are amongst the most vulnerable ‘hidden’ groups in society. Research suggests that up to one in five young people may live in families where a parent has mental health difficulties. Due to the way mental health services are organised in Ireland and other countries, the complex needs of these children and families often go unrecognised and untreated. For instance, most mental health services do not investigate the parenting status of service users because they are focused on the individual service user, adult and child/adolescent mental health services are separated, and staff might lack skills and resources in knowing how to deal with child welfare and protection. Many people have called for the treatment of mental health difficulties in parents of children to be more family-focused.
This study aims to investigate whether an approach called Family Talk can support the mental health of families where a parent has mental health difficulties. Research has shown that family-focused interventions can help parents and children cope with parental mental health difficulties. Family Talk (6-8 sessions) is a treatment with promising evidence for improving child mental health, child coping and resilience, parental mental health, coping and resilience, and family functioning. Family Talk is a strengths-based programme that can be used with any mental illness, and with scope for flexibility if required (for example, it can include a crisis plan). Family Talk involves parents, children and the whole family. Family Talk is attractive in an Irish context as it is similar to some previous, existing and proposed services in Ireland. Family Talk has freely available online training and resources. Family Talk has been used in Australia, Finland, Norway and Greece to support children and families when a parent has mental health difficulties.

Who can participate?
Parents aged over 18 years with children aged 5-18 years who are currently being treated or were treated in the last 18 months for a mental illness by a GP, psychiatrist or multidisciplinary team.

What does the study involve?
Families will be randomly allocated to receive Family Talk immediately or to go on waiting list to start Family Talk in 6 months’ time. In both groups, people with mental health difficulties and their families will receive treatment and support as usual from mental health services.
Family talk involves 6-8 sessions over 6-10 weeks. A trained healthcare professional will meet with the parents, children and other family members. The first two sessions involve the family discussing their experience and knowledge of mental illness. In session 3, the healthcare professional meets with the children alone to assess them and to identify any questions which the child(ren) may have about their parent’s mental health difficulties. Session 4 is a planning meeting between the healthcare professional and parents. Session 5 is a whole-family session to support family discussion and provide information on mental illness as needed. The follow-up meetings (after one week and after 3-6 months) are to check in and support the family going forward.

What are the possible benefits and risks of participating?
We hope that families will benefit from attending Family Talk, and that it will improve understanding and communication about mental health among family members. The data and feedback that families will give to the research team will be essential in informing government and funders about what is needed to provide better supports for other families when a parent has mental health difficulties.
There is a small risk during the study that families may experience some emotional distress either during or following questionnaires/interview. Safety measures and supports have been put in place in case this happens. If families experience any distress in attending Family Talk, they can discuss with their mental health worker who will support them.

Where is the study run from?
Maynooth University (Ireland) in collaboration with nine sites across Ireland (involving HSE, Tusla and Saint John of God organisations).

When is the study starting and how long is it expected to run for?
June 2017 to April 2021

Who is funding the study?
Health Service Executive Mental Health Division, Republic of Ireland

Who is the main contact?
1. Professor Sinéad McGilloway, Sinead.McGilloway@mu.ie
2. Dr Mairead Furlong, Mairead.Furlong@mu.ie

Trial website

https://cmhcr.eu/primera-programme/

Contact information

Type

Scientific

Primary contact

Prof Sinead McGilloway

ORCID ID

http://orcid.org/0000-0003-0988-3201

Contact details

Department of Psychology
John Hume Building
Maynooth University
Maynooth
Co. Kildare
Maynooth
W23 F2H6
Ireland
00353 1 7086052
Sinead.McGilloway@mu.ie

Type

Scientific

Additional contact

Dr Mairead Furlong

ORCID ID

http://orcid.org/0000-0002-9358-0635

Contact details

Department of Psychology
John Hume Building
Maynooth University
Maynooth
Co. Kildare
Maynooth
W23 F2H6
Ireland
00353 87 936 8199
Mairead.Furlong@mu.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial evaluation, cost-effectiveness study and process evaluation of the Family Talk intervention to improve child and parent mental health in families where a parent has mental health difficulties: The Promoting Research and Innovation in Mental hEalth seRvices for fAmilies (PRIMERA) Research Programme

Acronym

PRIMERA

Study hypothesis

The research will comprise a randomised controlled trial, with embedded process evaluation and an economic appraisal. Hypotheses/objectives related to each of these three elements are outlined:

1. Randomised controlled trial
• Compared to a control group of usual services, does the Family Talk intervention improve:
o Child emotional wellbeing and behaviour?
o Child resilience/coping skills?
o Child understanding of parental mental health difficulties?
o Family functioning?
o Parent mental health symptoms?
o Parent resilience/coping skills?
o Parent understanding of impact of mental illness on children?
o Partner wellbeing?

• Do outcomes vary at 6- and 12-month follow-ups?

2. Process evaluation

• What are the experiences and views of families/stakeholders at each site in receiving/delivering Family Talk, including in particular, the barriers and facilitators to implementation. Some key questions here are:
o What do families, clinicians and service providers think about the content of the programme?
o How did programme delivery go? Were there any barriers in this respect?
o What could be improved?
o Was the programme delivered in the way it was intended?

• To what extent have ‘think family’/family-focused practices become more embedded within mental health services in Ireland during the PRIMERA research (e.g. by seeking the views of clinicians/service providers and managers).

3. Economic appraisal
What is the cost effectiveness of Family Talk in improving child and family wellbeing compared with usual services? (e.g. Gather data on staff time and patterns of service-use amongst participants to calculate an Incremental Cost Effectiveness Ratio).

Ethics approval

1. Health Service Executive Research Ethics Committee, 17/09/2018, no reference number provided
2. Maynooth University Social Research Ethics Committee, 20/09/2018, ref: SRESC-2018-100
3. Tusla Research Ethics Review Group, 07/11/2018, no reference number provided
4. Saint John of God Research Ethics Committee – submitted, awaiting decision on 20/11/2018

Study design

Multicentre assessor-masked randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Families in which a parent has a mental illness

Intervention

Intervention: Family Talk
Family Talk (FT) is a manualised, strengths-based, 6-8 session programme (6-10 weeks) for families where a parent has mental health difficulties. Family Talk uses an individual family format and the trained clinician(s) meets with parents, children and the whole family. The first two sessions involve the clinician and parents and includes a discussion of the family’s experience of mental illness and psycho-education, as required. In session three, the clinician meets with the children alone to conduct an assessment and to identify any questions which the child(ren) may have in relation to their parent’s mental health difficulties. Next, a planning meeting between the clinician and parents is held, after which a whole family session is organised to support family discussion and provide information on mental disorders as needed. The intervention concludes with follow-up meetings (after one week and after 3-6 months) to check in and support the family going forward.

Control: Waitlist
The waitlist control group will receive services as usual. This will mean the parent will still receive individual treatment in Adult Mental Health Services (AMHS) for their mental health difficulties or, in a small number of cases, will be receiving medication/treatment from their GP. Waitlist families will be offered the FT intervention following the 6-month follow-up assessment period.

Randomisation procedure:
Baseline assessments will be conducted once suitable families have been identified, are considered eligible and have agreed to participate in the study. Participants will then be block-randomised by site location (using family as the unit of randomisation) and blindly and randomly allocated on a 2:1 basis to the intervention and control arms of the trial. Randomisation will be undertaken by an external research consultant/statistician using computerised random allocation procedures; an independent collaborator will conceal the allocation sequence until the grouping has been assigned. The use of block randomisation means that FT can be delivered in a staggered manner, with some participants beginning the intervention while further recruitment continues.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Child psychosocial functioning - measured by Strengths and Difficulties questionnaire, SCARED 5 (Screen for Child Anxiety Related Disorders) and RCADS child depression scale (Revised Children’s Anxiety and Depression Scale). Outcomes will be reported by parents and children and measured at baseline (pre-intervention), and 6 and 12 months later.
2. Family functioning - measured by SCORE 15 (Systematic Clinical Outcome and Routine Evaluation). Outcome will be reported by parents and children and measured at baseline (pre-intervention), and 6 and 12 months later.

Secondary outcome measures

1. Understanding and experience of parental mental health difficulties measured by the Understanding of Parental Mental Health questionnaire. Outcome will be reported by parents and children at baseline (pre-intervention), and 6 and 12 months later.
2. Child coping/resilience measured by the Children and Youth Resilience Measure reported by children at baseline (pre-intervention), and 6 and 12 months later.
3. Parental mental health measured by the BASIS 24 (Behaviour and Symptom Identification Scale) reported by parents at baseline (pre-intervention), and 6 and 12 months later.
4. Parental coping/resilience measured by the Coping Self Efficacy questionnaire reported by parents at baseline (pre-intervention) and 6 and 12 months later
5. Partner wellbeing assessed using the Warwick-Edinburgh Mental Wellbeing Scale reported by the partner themselves at baseline (pre-intervention) and 6 and 12 months later
6. Service utilisation assessed using the Services Utilisation Questionnaire reported by parents at baseline (pre-intervention) and 6 and 12 months later

Overall trial start date

01/06/2017

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Family participants:
1. Parent(s) aged over 18 – and with children aged 5-18 years - attending Adult Mental Health Services and who are under the care of a psychiatrist/multidisciplinary team (MDT) due to a formal (or working) diagnosis of mental difficulty
Or
2. Parent(s) with a mental difficulty episode in the last 18 months who had been under the care of a psychiatrist or MDT
Or
3. Parent(s) currently attending a GP for mental health issues (clinical responsibility will be provided by the GP and Family Talk clinician/service provider)
In all of the above cases, the parents’ symptoms should be relatively well maintained (i.e. not in crisis).

Staff participants:
Clinicians, service providers, and managers will be identified in collaboration with the lead contact person in each site. There are no inclusion or exclusion criteria with regard to staff participation.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

150

Participant exclusion criteria

Family participants:
1. Parents/children with active psychosis
2. Parents with active substance misuse such that they cannot engage with the intervention
3. Parents or children who are in hospital
4. Families with acrimonious dispute over child custody
5. Urgent need for child protection services

Depending on the level of resources available to staff, some sites may be able to support patients who have some level of active psychosis or substance misuse but it is key that families are able to engage with the intervention and agree to take part in the research. Where hospitalization or relapse occur during the delivery of Family Talk, the clinician must make a judgment whether the intervention can be merely postponed or would be better delivered at a later stage when the patient is more stable. Clinicians can discuss with families.

There are no exclusion criteria for other participants (clinicians, service providers, managers).

Recruitment start date

01/10/2018

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Cluain Mhuire Family Services
Cluain Mhuire Community Mental Health Services Newtownpark Avenue Blackrock Co. Dublin
Dublin
A94 H9T1
Ireland

Trial participating centre

Letterkenny Mental health Services
The Willows Carnamuggagh Letterkenny Co. Donegal
Letterkenny
F92 X2NT
Ireland

Trial participating centre

Crosslinx West Galway/Roscommon
Woodview/Unit 9A Merlin Park University Hospital Campus Galway
Galway
H91 HP0N
Ireland

Trial participating centre

Mayo Mental Health Services
CAMHS St. Mary’s Castlebar Co. Mayo
Castlebar
F23 HP58
Ireland

Trial participating centre

Louth Adult Mental Health Services
Singleton House Saint Lawrence St Drogheda Co. Louth
Drogheda
A92 F5DD
Ireland

Trial participating centre

Cherry Orchard AMHS/CAMHS/Tusla
Linn Dara Child & Adolescent Mental Health Services Cherry Orchard Campus
Dublin
D10 XR23
Ireland

Trial participating centre

Carlow AMHS with Recovery College South East
St Dympna’s Hospital Athy Road Carlow
Carlow
R93 DE62
Ireland

Trial participating centre

Tusla Louth Meath social work and Prevention Partnership and Family Support
Tusla Enterprise Centre Trim Rd. Navan Co. Meath
Navan
C15 DF2X
Ireland

Trial participating centre

Tusla Mayo social work and Prevention Partnership and Family Support
Tusla 2nd Floor Mill Lane Bridge Street Castlebar Mayo
Castlebar
F23 WP58
Ireland

Sponsor information

Organisation

Maynooth University

Sponsor details

Department of Psychology
John Hume Building
Maynooth University
Co. Kildare
Maynooth
W23 F2H6
Ireland
00353 1 708 6000
psychology.dept@mu.ie

Sponsor type

University/education

Website

https://www.maynoothuniversity.ie/

Funders

Funder type

Government

Funder name

Health Service Executive Mental Health Division, Republic of Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The research will be written up and presented in a series of summary reports/papers, presented at national and international conferences and will be published in scientific journals. A protocol of the trial will be submitted to Trials in 2019 and reports/articles from the study will be submitted for publication in 2020-2022. A copy of the research findings will be made available to participants upon request. Reports and other outputs will be uploaded to our study website https://cmhcr.eu/primera-programme/, We will also report findings from the process evaluation, costs, and a cost-effectiveness analysis of the Family Talk service compared with usual services.

IPD sharing statement
Where participants in the study provide consent, following the completion of the study (2021), we will place an anonymised version of their quantitative and qualitative data in the Irish Qualitative Data Archive (IQDA; https://www.maynoothuniversity.ie/iqda) and the Irish Social Science Data Archive (ISSDA;https://www.ucd.ie/issda/). These archives have been created to store anonymous data produced as part of social research projects conducted in Ireland, so that other researchers may be able to access and use these data in future studies. If any future research studies want to use this anonymised data, then the study will require approval from a research ethics committee. Once the data is deposited, there is no specified end date to its availability.

Intention to publish date

30/04/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes