Plain English Summary
Background and study aims.
Behaviour and emotional problems affect one in seven Australian children. These problems include aggression, hyperactivity, disobedience, anxiety, social withdrawal and depression. Around 50% of preschool children's problems continue through the childhood years. Since 2002, the Toddlers Without Tears (TWT) program has aimed to stop children from developing behaviour and emotional problems using a brief group parenting program. Families in Mind combines this brief program with a targeted treatment to examine whether combining the two programs is more effective than one program alone.
Families in Mind has been designed by child doctors, child psychologists and maternal and child health nurses. It is a three-arm trial:
1. Combined arm: a brief group parenting program (modelled on TWT) plus a targeted one-on-one family support program
2. Targeted arm: a one-on-one family support program
3. Usual care arm: no extra programs but families can access help from usual services
Families in Mind is suitable for all families with young children, and uses parenting handouts, group discussion, and video examples.
The aims of the study are to:
Help parents learn how to encourage positive toddler behaviour, and reduce aggressive and anxious behaviours
Understand how child behaviour and emotional problems develop in the first six years of life (from infancy)
Prevent young children from developing behaviour and emotional problems as they grow
Measure the economic costs of delivering this parenting program, including the targeted one-on-one support in the community
Who can participate?
English-speaking families with a healthy child attending their routine, 8-month, free Maternal and Child Health visit in one of nine Local Government Areas in Melbourne, Australia.
What does the study involve?
In 2010, 1500 families who choose to take part are randomly divided into three groups: Combined, Targeted and Usual care. Families in the combined arm are invited to attend three parenting groups run in their local area by Maternal and Child Health Nurses when their children turn 15, 18 and 24 months old. These groups are based on the Toddlers Without Tears study and focus on parenting practices to prevent behaviour problems. In 2012, all families are followed up as their children turn 2 years old. Families in the Combined and Targeted arms who need extra support are offered the targeted one-on-one support program. In 2013, all families are followed up as their children turn 3-4 years of age. In 2014, all families are followed up as their children turn 4-5 years of age.
What are the possible benefits and risks of participating?
Parents receiving one or more of the treatments may benefit from improved parenting skills, child behaviour and mental health at child age 3 and 4-5 years. We do not expect there to be any risks associated with taking part.
Where is the study run from?
The Murdoch Childrens Research Institute and The Royal Childrens Hospital, Melbourne, Australia.
When is the study starting and how long is it expected to run for?
Recruitment began in August 2010 and the study is expected to end in September 2015
Who is funding the study?
NHMRC Partnership Grant 546525
Who is the main contact?
Associate Professor Harriet Hiscock
harriet.hiscock@rch.org.au
Trial website
Contact information
Type
Scientific
Primary contact
Dr Harriet Hiscock
ORCID ID
Contact details
Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Road
Parkville
Victoria
Melbourne
3052
Australia
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Harriet.Hiscock@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Preventing mental health problems in children: a population-based cluster controlled trial
Acronym
Study hypothesis
This population-level randomised control trial aims to prevent behavioural and emotional problems from developing in pre-school children. The study has three arms: (A) combined universal-targeted approach; (B) targeted approach; and (C) usual care. We hypothesise that:
1. Each of the combined universal-targeted approach (A) and the targeted only approach (B) will be more effective and have greater population reach than current primary care services (C)
2. Uptake of the targeted prevention component for families where the child is at "high risk" of behavioural problems will be greater under the combined universal-targeted approach (A) than under the targeted only approach (B)
Ethics approval
Royal Children's Hospital Melbourne Ethics and Research Board approved on the 17/06/2010 (ref: 29144A)
Study design
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 contact Ms Kate Lycett [kate.lycett@mcri.edu.au] to request a patient information sheet
Condition
Child externalising and internalising problems
Intervention
Arm A: All families in this group will be offered a parenting program (universal approach). This involves attending a parenting session when their child is 15, 18 and 24 months old. If at about 2 years of age a child is having behaviour or emotional difficulties or a family feels stressed, a one-on-one family support program (targeted approach) will also be offered.
Arm B: Some families in this group will be offered one-on-one family support (targeted approach). Families will be offered this service if their child is having behaviour or emotional difficulties at about age 2 or if the family feels stressed.
Arm C: Families in this group will only be offered usual care by their maternal child health nurse
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Current primary outcome measures as of 30/08/2013:
Child externalising and internalising diagnoses/symptoms at age 3 and 4-5 years.
Previous primary outcome measures:
Child externalising and internalising diagnoses/symptoms and a measure of parent behaviour (nurturing/harsh discipline) at ages 3, 4 and 5.
Secondary outcome measures
Current secondary outcome measures as of 30/08/2013:
Parenting practice (harsh discipline, nurturing), parent mental health and economic evaluation at age 3 and 4-5 years.
Previous secondary outcome measures:
Parenting practices, parent mental health, and economic evaluation at ages 3, 4 and 5.
Overall trial start date
01/08/2010
Overall trial end date
30/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Eligible participants are parents (primarily mothers) of 8 month old babies in 9 Melbourne local government areas. Parents will be invited to join the study between August and October 2010. We expect an even distribution of girls and boys in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target sample size is 1475
Participant exclusion criteria
1. Parents with insufficient English to participate
2. Parents with babies with a major health condition
Recruitment start date
01/08/2010
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Community Child Health
Melbourne
3052
Australia
Sponsor information
Organisation
National Health and Medical Research Council (NHMRC) (Australia)
Sponsor details
Level 1
16 Marcus Clarke Street
Canberra
2601
Australia
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (ref: 546525)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Australia
Funder name
Department of Human Services (Australia) - Mental Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Human Services (Australia) - Primary Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Municipal Associations of Victoria (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Education and Early Childhood (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22682229
2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/28902067 (added 31/01/2019)
Publication citations
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Protocol
Hiscock H, Bayer JK, Lycett K, Ukoumunne OC, Shaw D, Gold L, Gerner B, Loughman A, Wake M, Preventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial., BMC Public Health, 2012, 12, 420, doi: 10.1186/1471-2458-12-420.