Identifying child anxiety through schools
| ISRCTN | ISRCTN76119074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76119074 |
| Secondary identifying numbers | CUREC Ref: R66068. CPMS 50940 |
- Submission date
- 08/12/2021
- Registration date
- 04/01/2022
- Last edited
- 18/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
Anxiety problems are common among primary-school aged children, but very few children who experience problems with anxiety receive professional support. We have worked with children, parents/carers, school staff and others to develop a new way of identifying and supporting children with anxiety problems through primary schools. We now want to compare this new approach to existing, usual school practice. In this study, we will compare children’s outcomes in schools that do and do not receive our procedures for identification-to-intervention.
Who can participate?
Children in year 4 (aged 8-9) in participating classes in participating schools
What does the study involve?
Children, parents/carers and class teachers will be invited to complete initial questionnaires, and we will also collect information about children from school records. Schools will then be randomly allocated to either 'feedback and intervention' or 'usual school practice'.
Families in schools allocated to 'feedback and intervention' group will receive feedback on whether responses to a short initial questionnaire completed by parents suggest their child may be or is unlikely to be experiencing difficulties with anxiety. Where responses suggest a child may be experiencing difficulties with anxiety, parents will be offered a brief, therapist supported online intervention. The intervention will also be made available to all participating families in these schools, regardless of initial questionnaire responses.
Families in schools allocated to usual school practice' will continue to receive any usual support available in their school and elsewhere, and at the end of study (2 years later) they will be offered written (PDF) versions of the intervention.
Children, parents/carers and class teachers in all schools will be asked to complete questionnaires again after4 months, 12 months and 24 months.
What are the possible benefits and risks of participating?
Families who take part will all be offered either a brief online and telephone support intervention as part of the study, or a written (PDF) version of the online intervention at the end of the study.
Participants will need to spend some time completing questionnaires. Although we work hard to try to make sure the questions are as acceptable as possible, some questions address thoughts and feelings that some participants may find upsetting.
Where is the study run from?
Oxford Health NHS Foundation Trust/ University of Oxford (UK)
When is the study starting and how long is it expected to run for?
August 2021 to November 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Lucy Taylor, lucy.taylor@psych.ox.ac.uk
Contact information
Prof Cathy Creswell
Scientific
Scientific
Departments of Experimental Psychology and Psychiatry
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0003-1889-0956 |
|---|---|
| Phone | +44 (0)1865 618175 |
| cathy.creswell@psych.ox.ac.uk |
Ms Lucy Taylor
Public
Public
Departments of Experimental Psychology and Psychiatry
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| Phone | +44 (0)1865 618175 |
|---|---|
| lucy.taylor@psych.ox.ac.uk |
Dr Tessa Reardon
Scientific
Scientific
Departments of Experimental Psychology and Psychiatry
University of Oxford
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0000-0002-9298-091X |
|---|---|
| Phone | +44 (0)1865 618175 |
| tessa.reardon@psych.ox.ac.uk |
Study information
| Study design | Interventional cluster randomized controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | https://osiresearch.org.uk/icats/family-info/ |
| Scientific title | Identifying Child Anxiety Through Schools – identification to intervention (iCATSi2i): a cluster randomised controlled trial |
| Study acronym | iCATSi2i |
| Study hypothesis | Primary objective: To compare outcomes for children (aged 8-9) who screen positive at baseline in schools allocated to ‘feedback and intervention’ versus ‘usual school practice’ Secondary objectives: 1. To estimate the cost-effectiveness of ‘feedback and intervention’, extrapolating results beyond the end of the trial duration 2. To evaluate experiences of procedures for identification-feedback-intervention to inform an integrated process evaluation 3. To compare outcomes for the total population of Year 4 children (aged 8-9) in participating classes in schools allocated to ‘feedback and intervention’ versus ‘usual school practice’ |
| Ethics approval(s) | Approved 06/10/2021, 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: R66068/RE001 |
| Condition | Anxiety problems |
| Intervention | Current intervention as of 11/04/2022: Children in Year 4 (aged 8-9 years) in participating classes and their parent/carer and class teacher will be invited to take part. Assessments will be completed at baseline (before randomisation), and 4 months, 12 months and 24 months post-randomisation. Our target population is children who screen positive (score above the cut-off on the 2-item parent-report child anxiety questionnaire) at baseline, but we will also follow-up all recruited children (total population). The trial will include an internal pilot. We will recruit schools in two cohorts one year apart (pilot phase: 30 schools; phase 2: 50 schools). The decision to continue beyond the pilot phase will be taken by the funder, with advice from the independent programme steering committee. After baseline assessments are complete in a cohort of schools, schools will be randomised by an independent statistician to either 'feedback and intervention' or 'usual school practice' in a 1:1 ratio stratified according to school demographic information. The statistician will pass the allocation to the study team who will notify schools and families. 'Feedback and intervention' arm: i) Feedback Parents/carers who complete the baseline 2-item child anxiety questionnaire will receive a written feedback letter that informs them whether their responses indicate their child may be experiencing difficulties with anxiety or is unlikely to be experiencing difficulties with anxiety. The letter also provides information about the intervention programme. Where a child 'screens positive', the parent/carer has a short feedback call with a study Wellbeing Practitioner or Clinical Psychologist, and is offered the intervention programme. Where a child 'screens negative', the feedback letter will invite parents/carers to contact the research team if they may be interested in taking part in the intervention and/or would like to discuss this option. The intervention programme will also be made available for all families in the 'Feedback and intervention' arm, including those where parents/carers did not give initial opt-in consent/complete baseline measures. ii) Lesson on recognising and managing anxiety and resources for school staff The research team and/or school staff will deliver a whole-class lesson on recognising and managing anxiety, and we will share information about the intervention and skills and strategies parents learn in the intervention with school staff. iii) Online Support and Intervention for child anxiety (OSI) Parents/carers work through seven online modules. Each module is supported by a short weekly telephone session with a therapist, and a follow-up telephone review about 4 weeks later. There is also an accompanying app for the child that is a game for mobile phones/tablets. Schools will continue to provide any usual support, and families will be free to continue to seek and/or receive any other additional support from school and/or other service providers throughout the trial. Usual school practice arm: Schools will continue to provide any usual support, and families will be free to continue to seek and/or receive any other additional support from school and/or other service providers throughout the trial. After the 24-month assessment, families will be offered a written (PDF) version of the content of the online intervention. _____ Previous intervention: Children in Year 4 (aged 8-9 years) in participating classes and their parent/carer and class teacher will be invited to take part. Assessments will be completed at baseline (before randomisation), and 6-months, 12 months and 24-months post-randomisation. Our target population is children who screen positive (score above the cut-off on the 2-item parent-report child anxiety questionnaire) at baseline, but we will also follow-up all recruited children (total population). The trial will include an internal pilot. We will recruit schools in two cohorts one year apart (pilot phase: 30 schools; phase 2: 50 schools). The decision to continue beyond the pilot phase will be taken by the funder, with advice from the independent programme steering committee. After baseline assessments are complete in a cohort of schools, schools will be randomised by an independent statistician to either ‘feedback and intervention’ or ‘usual school practice’ in a 1:1 ratio stratified according to school demographic information. The statistician will pass the allocation to the study team who will notify schools and families. ‘Feedback and intervention’ arm: i) Feedback Parents/carers who complete the baseline 2-item child anxiety questionnaire will receive a written feedback letter that informs them whether their responses indicate their child may be experiencing difficulties with anxiety or is unlikely to be experiencing difficulties with anxiety. The letter also provides information about the intervention programme. Where a child ‘screens positive’, the parent/carer has a short feedback call with a study Wellbeing Practitioner or Clinical Psychologist, and is offered the intervention programme. Where a child ‘screens negative’, the feedback letter will invite parents/carers to contact the research team if they may be interested in taking part in the intervention and/or would like to discuss this option. The intervention programme will also be made available for all families in the ‘Feedback and intervention’ arm, including those where parents/carers did not give initial opt-in consent/complete baseline measures. ii) Lesson on recognising and managing anxiety and resources for school staff The research team and/or school staff will deliver a whole-class lesson on recognising and managing anxiety, and we will share information about the intervention and skills and strategies parents learn in the intervention with school staff. iii) Online Support and Intervention for child anxiety (OSI) Parents/carers work through seven online modules. Each module is supported by a short weekly telephone session with a therapist, and a follow-up telephone review about 4-weeks later. There is also an accompanying app for the child that is a game for mobile phones/tablets. Schools will continue to provide any usual support, and families will be free to continue to seek and/or receive any other additional support from school and/or other service providers throughout the trial. Usual school practice arm: Schools will continue to provide any usual support, and families will be free to continue to seek and/or receive any other additional support from school and/or other service providers throughout the trial. After the 24-month assessment, families will be offered a written (PDF) version of the content of the online intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Absence/presence of child anxiety problems 12 months post-randomisation in the target population determined by score below/above the cut-off on the 2-item parent-report child anxiety questionnaire |
| Secondary outcome measures | Current secondary outcome measures as of 11/04/2022: 1. Secondary clinical outcomes measured in the target population and total population at baseline, 4 months, 12 months, 24 months post-randomisation: 1.1 Child anxiety measured using the brief Spence Children’s Anxiety Scale (SCAS-8), together with an impact supplement (child-report, parent -report, and teacher-report), and the Revised Children’s Anxiety and Depression Scale (RCADS)-Anxiety Scale (child-report and parent-report) 1.2 Child depression symptoms measured using the Revised Children’s Anxiety and Depression Scale (RCADS)-Depression Scale (child-report and parent-report) 1.3 Child emotional and behavioural problem symptoms measured using the Strengths and Difficulties Questionnaire (SDQ) (child-report and parent -report) 2. Health economic outcomes measured in the target population and total population at baseline, 4 months, 12 months, 24 months post-randomisation: 2.1 Child quality of life measured using Child Health Utility 9D-(child-report and parent/carer report on child) and EQ-5D-Y (child-report and parent/carer report on child) 2.2 Parent/carer quality of life measured using EQ-5D-5L (parent self-report) 2.3 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 2.4 Time spent on intervention delivery measured using therapist, supervisor and school staff completed logs throughout 3. Education related outcomes in the target population and total population collected from school records and (if approved) from the National Pupil Database, including: 3.1 School attendance and punctuality up to the end of Year 6 (age 11) 3.2 Academic attainment up to the end of Year 6 (age 11) 4. Participant experiences and process evaluation outcomes 4.1 Experiences of procedures for identification, feedback and intervention and process evaluation outcomes will be assessed via qualitative interviews with children, parents/carers, school staff, other stakeholders and members of the research team involved in delivering the intervention, during and after the intervention delivery period. 4.2 Experiences of study procedures measured by a bespoke child, parent, and teacher-report acceptability-questionnaire at baseline, 4 months, 12 months, 24 months post-randomisation _____ Previous secondary outcome measures : 1. Secondary clinical outcomes measured in the target population and total population at baseline, 6-months, 12-months, 24-months post-randomisation: 1.1 Child anxiety measured using the brief Spence Children’s Anxiety Scale (SCAS-8), together with an impact supplement (child-report, parent -report, and teacher-report), and the Revised Children’s Anxiety and Depression Scale (RCADS)-Anxiety Scale (child-report and parent-report) 1.2 Child depression symptoms measured using the Revised Children’s Anxiety and Depression Scale (RCADS)-Depression Scale (child-report and parent-report) 1.3 Child emotional and behavioural problem symptoms measured using the Strengths and Difficulties Questionnaire (SDQ) (child-report and parent -report) 2. Health economic outcomes measured in the target population and total population at baseline, 6-months, 12-months, 24-months post-randomisation: 2.1 Child quality of life measured using Child Health Utility 9D-(child-report and parent/carer report on child) and EQ-5D-Y (child-report and parent/carer report on child) 2.2 Parent/carer quality of life measured using EQ-5D-5L (parent self-report) 2.3 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 2.4 Time spent on intervention delivery measured using therapist, supervisor and school staff completed logs throughout 3. Education related outcomes in the target population and total population collected from school records and (if approved) from the National Pupil Database, including: 3.1 School attendance and punctuality up to the end of Year 6 (age 11) 3.2 Academic attainment up to the end of Year 6 (age 11) 4. Participant experiences and process evaluation outcomes 4.1 Experiences of procedures for identification, feedback and intervention and process evaluation outcomes will be assessed via qualitative interviews with children, parents/carers, school staff, other stakeholders and members of the research team involved in delivering the intervention, during and after the intervention delivery period. 4.2 Experiences of study procedures measured by a bespoke child, parent, and teacher-report acceptability-questionnaire at baseline, 6-months, 12-months, 24-months post-randomisation |
| Overall study start date | 01/07/2021 |
| Overall study end date | 30/11/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Schools: 80; Target population: 398 children and their parent/carers and class teachers; Total population: 4471 children, 1987 parents/carers, 552 teachers |
| Participant inclusion criteria | Schools: 1. Mainstream primary/junior in England with at least 2 classes with Year 4 pupils 2. A minimum of 40 Year 4 pupils on school roll Classes: 1. Where schools have two or three Year 4 classes, all Year 4 classes will take part 2. Where schools have more than three Year 4 classes, three classes will be randomly selected to take part Total population: 1. Children 1.1 Child is in Year 4 in a participating class 1.2 Child’s parent/carer has not opted out 2. Parents/carers 2.1 Parent/carer of a child in Year 4 in a participating class. Families will be asked to nominate one parent/carer to complete parent-report measures. 3. Teachers 3.1 Baseline: class teacher or member of support staff who works regularly with children in a participating class 3.2 Follow-up: participating child’s current class teacher/member of support staff who works regularly with them Target population: 1. Children: Child screens positive (scores above the cut-off) on the 2-item parent-report child anxiety questionnaire at baseline 2. Parents/carers: Parent/carer of a child who screens positive (score above the cut-off) on the 2-item parent-report child anxiety questionnaire at baseline 3. Teachers: Class teacher or member of support staff who works regularly with a child who screens positive (scores above the cut-off) on the 2-item parent-report child anxiety questionnaire at baseline Intervention (OSI) participants: 1. Parent/carer of a child in a school randomised to ‘Feedback and Intervention’ 2. Child screened positive (scored above the cut-off on 2-item parent-report child anxiety questionnaire) at baseline and/or the parent/carer decides to take up the intervention offer 3. Where more than one child in a household or family takes part in the trial, the parent/carer will be offered the intervention for one child only. Qualitative interviews: 1. Children: Child is in Year 4 in a participating class in a school allocated to ‘feedback and intervention’ and parent/carer provides consent 2. Parents/carers: Parent/carer of child in Year 4 in a participating class in a school allocated to ‘feedback and intervention’ 3. School staff: Member of staff in a participating school in a school allocated to ‘feedback and intervention’ 4. Other key stakeholders: Governor in participating school or representative of another key stakeholder organisation who has a professional role within or related to a participating school, for example a mental health service provider, local authority, local policy maker organisations (e.g. local public health team) 5. Members of the research team involved in delivering the intervention: Children’s Wellbeing Practitioner or Clinical Psychologist who delivered and/or supervised the delivery of OSI as part of the trial |
| Participant exclusion criteria | Schools: Schools with a current “Mental Health Support Team” (as part of the DfE/NHS England initiative) Children: Children who do not have sufficient English language or comprehension skills to answer questions, even with support, will not complete measures themselves Parents/carers: Parents who do not have sufficient English language or comprehension skills to answer questions and/or take part in the intervention, even with support, will not take part |
| Recruitment start date | 05/01/2022 |
| Recruitment end date | 30/11/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warneford Hosptial
Oxford Health NHS Foundation Trust & University of Oxford
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Sponsor information
University of Oxford
University/education
University/education
Department of Experimental Psychology
Anna Watts Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
England
United Kingdom
| Phone | +44 (0)1865 271444 |
|---|---|
| research@psy.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Not defined
National Institute for Health Research (NIHR)
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The study protocol will be published in due course. Outcomes will be published in high-quality publications and through additional routes to reach academic, educational, clinical, policymaker and public audiences. All publications will be open access. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/10/2022 | 24/10/2022 | Yes | No | |
| Statistical Analysis Plan | 17/01/2024 | 18/01/2024 | No | No |
Editorial Notes
18/01/2024: Publication reference added.
12/12/2022: The recruitment end date has been changed from 30/12/2022 to 30/11/2024.
24/10/2022: Publication reference added.
11/04/2022: The following changes have been made:
1. The intervention has been changed.
2. The secondary outcome measures have been changed.
3. The plain English summary has been updated to reflect these changes.
13/12/2021: Trial's existence confirmed by University of Oxford
