Preventing Anxiety in Children through Education in Schools
| ISRCTN | ISRCTN23563048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23563048 |
| Secondary identifying numbers | NIHR/PHR/09/3000/03 |
- Submission date
- 13/09/2010
- Registration date
- 06/10/2010
- Last edited
- 03/11/2016
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Stallard
Scientific
Scientific
Department for Health
22-23 Eastwood
University of Bath
Bath
BA2 7AY
United Kingdom
Study information
| Study design | Randomised controlled cluster trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A randomised controlled cluster trial comparing the effectiveness and cost effectiveness of a school based cognitive behaviour therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10 years |
| Study acronym | PACES |
| Study objectives | Group based cognitive behaviour therapy (FRIENDS) delivered by trained school and health staff is effective and cost effective in preventing anxiety and improving mood compared to usual school lessons (Personal, Social and Health Education [PSHE]). |
| Ethics approval(s) | The University of Bath, School Research Ethics Approval Panel, 28/07/2010, ref: PACES/SREAP |
| Health condition(s) or problem(s) studied | Anxiety |
| Intervention | Schools will be randomised to one of three treatment groups: 1. Health-led FRIENDS: The intervention will be delivered by trained and supervised health professionals (e.g. school nurses, psychology assistants) external to the school. 2. School-led FRIENDS: The intervention will be delivered by trained and supervised members of the school teaching group. FRIENDS involves ten, 60-minute weekly sessions of cognitive behaviour therapy. Intervention teaches children practical skills to identify their feelings; to learn to relax; to identify unhelpful thoughts and to replace them with more helpful thoughts; and how to face and overcome their problems and challenges. 3. Treatment as Usual: Children will participate in the usual personal social and health education (PSHE) lessons provided by the school. These lessons will be planned and led by the class teacher. A standardised record sheet will be used to summarise the content of each session so that any potential overlap with the active intervention can be determined. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Children: Children's Anxiety Scale 2. Parents and teachers: Strength and Difficulties Questionnaire Used to assess changes in anxiety and symptoms of low mood at baseline, 6 and 12 months. |
| Secondary outcome measures | 1. Children: Children's Anxiety Scale, used to assess changes in self esteem and bullying 2. Parents and teachers: Strength and Difficulties Questionnaire All assessments will be undertaken at baseline, 6 and 12 months. |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 1080 children attending 54 schools |
| Key inclusion criteria | All children aged 9 - 10 years (years 4 and 5) attending study schools (n = 54) and participating in PSHE lessons |
| Key exclusion criteria | None. There will be some occasions when children do not participate in PSHE for religious or other reasons. These will be respected but it is expected that these will be limited. |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Bath
Bath
BA2 7AY
United Kingdom
BA2 7AY
United Kingdom
Sponsor information
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Jenner House
Langley Park Estate
Wiltshire
Chippenham
SN15 1GG
England
United Kingdom
| Website | http://www.awp.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/0379k6g72 |
Funders
Funder type
Government
Public Health Research Programme (ref: 09/3000/03)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Public Health Research Programme, PHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/11/2012 | Yes | No | |
| Protocol article | 24-month follow-up protocol | 13/03/2014 | Yes | No | |
| Results article | results | 01/08/2014 | Yes | No | |
| Results article | results | 01/11/2015 | Yes | No | |
| Results article | results | 01/11/2016 | Yes | No |
Editorial Notes
03/11/2016: Publication reference added.
