Plain English Summary
Background and aims
Anxiety disorders are common and create a substantial personal and societal burden. Intervening before anxiety problems become ingrained and have an ongoing impact on children’s lives would benefit families and wider society. Elevated anxiety symptoms, inhibited temperament and high parental anxiety are risk factors for later anxiety disorders in children. There is emerging evidence that prevention can be effective in each of these contexts. The reach of prevention could be substantially improved by delivering an online intervention through schools to parents of children who have one or more of these risks. Furthermore, identifying moderators and mediators of child outcomes will establish who to target and how to optimise prevention.
The main aims of this study are to establish if a supported online intervention for parents of at-risk children (4-7 years) reduces the frequency of anxiety disorders 1 year later, and to identify who benefits most and how to maximise outcomes.
Who can participate?
Parents/carers of children (aged 4-7) in reception, year 1 and year 2 classes in participating schools will be invited to take part in screening. Parents/carers of children who screen positive on the basis of child anxiety symptoms, behavioural inhibition and/or parent anxiety symptoms will be eligible.
What does the study involve?
Parents/carers of children in participating classes will be invited to complete screening questionnaires. Following screening, the research team will contact parents/carers to let them know the outcome of the screening and whether they are eligible or not.
Parents/carers who agree to take part will be asked to complete some more questionnaires.
Half of the participating schools will be allocated to the intervention group, and half to the usual school practice group. Participating parents/carers of children in schools allocated to the intervention group will receive a therapist-supported online programme. Parents/carers of children in schools in the usual school practice group will continue to receive any usual support available at their school, and at the end of the project will receive PDF versions of the online programme.
Parents/carers in both groups will be asked to complete questionnaires again after 6 weeks and 12 weeks, and to complete questionnaires and take part in an interview after 12 months.
What are the possible benefits and risks of participating?
The researchers have good reason to think that most families who receive the therapist supported online programme or the PDF version of the programme at the end of the project will benefit.
Parents/carers will need to spend time completing questionnaires and an interview. The researchers work with families to try to make sure the questions we ask are as acceptable as possible, but the questions address thoughts and feelings that may be upsetting for some participants.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
May 2020 to December 2022
Who is funding the study?
The Kavli Trust (USA)
Who is the main contact?
Anna Placzek
mycats@psych.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Cathy Creswell
ORCID ID
http://orcid.org/0000-0003-1889-0956
Contact details
Department of Experimental Psychology
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 271444
cathy.creswell@psych.ox.ac.uk
Type
Scientific
Additional contact
Dr Tessa Reardon
ORCID ID
http://orcid.org/0000-0002-9298-091X
Contact details
Department of Experimental Psychology
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 271444
tessa.reardon@psy.ox.ac.uk
Type
Public
Additional contact
Ms Anna Placzek
ORCID ID
http://orcid.org/0000-0002-6745-5996
Contact details
Department of Experimental Psychology
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 271444
anna.placzek@psych.ox.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Minimising Young Children’s Anxiety Through Schools (MY-CATS): a cluster randomised controlled trial
Acronym
MY-CATS
Study hypothesis
Primary objective: To compare diagnostic outcomes 12 months post-randomisation for children who screen-positive on one or more risk factors in schools allocated to the intervention versus usual school practice.
Study hypothesis: Fewer children have an anxiety disorder in the intervention arm compared to the usual school practice arm at 12 months post-randomisation.
Secondary objectives:
1. To compare anxiety symptoms, related interference and externalising symptoms 12 weeks and 12 months post-randomisation for children who screen-positive on one or more risk factor in schools allocated to intervention compared to usual school practice
2. To identify moderators (including number of risks) and mediators of the primary outcome
3. To evaluate experiences of systematic screening
4. To evaluate experiences of the supported parent-led online intervention
5. To estimate the cost-effectiveness of the intervention compared to usual school practice, 12 months post-randomisation and model potential cost-effectiveness in the future
Ethics approval
Approved 06/01/2021, Medical Sciences Interdivisional Research Ethics Committee (Research Services, University of Oxford, Wellington Square, Oxford, OX1 2JD, UK; +44 (0)1865 616577; ethics@medsci.ox.ac.uk), ref: R62531/RE001
Study design
Interventional cluster randomized controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
See additional files
Condition
Anxiety disorders
Intervention
Schools will be randomised to the intervention or usual school practice arm in a 1:1 ratio stratified according to school-demographic information. An independent statistician will conduct randomisation via a computer-generated algorithm. Schools will be randomised on block, after screening, participant enrolment and baseline assessments have been completed in a cohort of schools. The statistician will pass the allocation to the Trial Manager who will assign schools to arms.
Assessment points for both arms will be: screening, baseline, 6 weeks, 12 weeks and 12-months post-randomisation.
Intervention arm: Parents/carers of children identified as ‘at risk’ for developing anxiety problems in schools randomised to the intervention arm will work through OSI (Online Support and Intervention for Child Anxiety). OSI is an online version of an evidence-based parent-guided Cognitive Behaviour Therapy (CBT) intervention for child anxiety, and the content has been adapted for parents of children aged 4-7 years who are at risk of anxiety disorders. Parents work through seven online modules (one module per week), with each supported by a brief (15 – 20 minute) telephone session with a Children’s Wellbeing Practitioner, and a follow-up review 4 weeks after the intervention is complete. There is also an accompanying mobile game app for the child designed to help motivate the child to face their fears.
Usual school practice arm: Parents/carers of children identified as ‘at risk’ for developing anxiety problems in schools randomised to the usual school practice arm will continue to receive any usual support available in their school. At the end of the trial (after 12-month follow-up), parents/carers will receive PDF versions of the online intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Absence/presence of an anxiety disorder measured using Anxiety Disorder Interview Schedule-Child Version-Parent Interview (ADIS-P) at 12-months post-randomisation
Secondary outcome measures
1. Secondary clinical outcomes measured at baseline, 12-weeks and 12-months post-randomisation:
1.1. Child anxiety symptoms measured using the Preschool Anxiety Scale -parent/carer report
1.2. Inference caused by child anxiety measured using the Child Anxiety Life Interference Scale-Preschool version-parent/carer report
1.3. Child externalising symptoms measured using the Strengths and Difficulties Questionnaire-Externalising Scale-parent/carer report
2. Moderators of primary outcome measured at screening and baseline:
2.1. Child age, child gender, child ethnicity, parent gender, parent ethnicity, and family socioeconomic status measured using parent/carer-report bespoke socio-demographic questionnaire
2.2. Risk factors (child anxiety symptoms, behavioural inhibition, parent anxiety symptoms) and number/combination of risk factors measured using Preschool Anxiety Scale-parent/carer report, Approach subscale of the Short Temperament Scale for Children-parent/carer report, Generalised Anxiety Disorder-7 (GAD-7) Scale-parent self-report
3. Mediators of primary outcome measured at baseline, 6-weeks, 12-weeks and 12-months post randomisation:
3.1. Risk factors (child anxiety symptoms, behavioural inhibition, parent anxiety symptoms) measured using Preschool Anxiety Scale-parent/carer report, Approach subscale of the Short Temperament Scale for Children-parent/carer report, Generalised Anxiety Disorder-7 (GAD-7) Scale
3.2. Additional intervention targets, including:
3.2.1. Parent overprotection measured using the Parental Overprotection Scale-parent/carer report
3.2.2. Parenting self-efficacy measured using the Parenting Sense of Competence Scale-self-efficacy subscale-parent/carer report
3.2.3. Child behavioural avoidance measured using the Child Avoidance Measure-parent/carer report
3.2.4. Child coping efficacy measured using an adapted version of the Coping Questionnaire-parent/carer report
3.2.5. Child intolerance of uncertainty measured using the Responses to Uncertainty and Low Environmental Structure questionnaire-parent/carer report
4. Experiences of screening and intervention assessed using one-to-one qualitative interviews with parents/carers, children, school staff throughout the project and bespoke parent-report acceptability questionnaire at 12-months
5. Economic outcomes measured at baseline, 12-weeks and 12-months post-randomisation:
5.1. Child quality of life measured using Child Health Utility 9D-(parent/carer report on child) and EQ-5D-Y-proxy version (parent/carer report on child)
5.2. Parent/carer quality of life measured using EQ-5D-5L (self-report)
5.3. Individual resource use (e.g. service use, time off school and work) measured using a modified version of the Client Service Receipt Inventory (CSRI)-parent/carer report
5.4. Time spent on intervention delivery measured using therapist and supervisor completed logs throughout
Overall trial start date
01/05/2020
Overall trial end date
31/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Schools: mainstream infant/primary school in England, with a minimum of two classes per target year.
2. Screening: child in Reception, Year 1 or Year 2 in a participating school (aged 4-7 years). One parent/carer will complete screening questionnaires for each child.
3. Trial: child screens positive on child anxiety symptoms, and/or behavioural inhibition, and/or parent/carer anxiety symptoms.
4. Qualitative interviews: parents/carers who take part in screening, school staff in participating schools and children of parents/carers who take part in the intervention
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
1080 participants from 60 schools; 30 schools (clusters) and 540 participants per arm
Participant exclusion criteria
1. Parent/carer does not have sufficient use of English to provide consent, complete measures and/or take part in the intervention
2. Parent/carer does not have frequent access to the internet, either at home or elsewhere
Recruitment start date
01/02/2021
Recruitment end date
31/10/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Department of Experimental Psychology
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
Department of Experimental Psychology
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 271444
research@psy.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Kavli Foundation
Alternative name(s)
The Kavli Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United States of America
Results and Publications
Publication and dissemination plan
The researchers are planning to publish the study protocol in due course.
The outcomes will be published in high-quality publications that reach academic, clinical and educational audiences, as well as through newsletters, study websites, social media etc. All publications will be open access. The findings will also be presented at international and national conferences and will be published on websites that have extensive reach to academic, educational, policymaker and public audiences (e.g. https://www.nationalelfservice.net/mental-health/).
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/07/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list