Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NIHR/PHR/09/3000/03
Study information
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
Acronym
PACES
Study hypothesis
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
The University of Bath, School Research Ethics Approval Panel, 28/07/2010, ref: PACES/SREAP
Study design
Randomised controlled cluster trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children aged 9 - 10 years (years 4 and 5) attending study schools (n = 54) and participating in PSHE lessons
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1080 children attending 54 schools
Participant 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.
Recruitment start date
01/01/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bath
Bath
BA2 7AY
United Kingdom
Sponsor information
Organisation
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Sponsor details
Jenner House
Langley Park Estate
Wiltshire
Chippenham
SN15 1GG
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Public Health Research Programme (ref: 09/3000/03)
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23186118
2014 24-month follow-up protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24624990
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/26360730
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26598778
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27426426
Publication citations
-
Protocol
Stallard P, Taylor G, Anderson R, Daniels H, Simpson N, Phillips R, Skryabina E, School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)., Trials, 2012, 13, 227, doi: 10.1186/1745-6215-13-227.
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Protocol
Stallard P, Taylor G, Anderson R, Daniels H, Simpson N, Phillips R, Skryabina E, The prevention of anxiety in children through school-based interventions: study protocol for a 24-month follow-up of the PACES project., Trials, 2014, 15, 77, doi: 10.1186/1745-6215-15-77.
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Results
Stallard P, Skryabina E, Taylor G, Phillips R, Daniels H, Anderson R, Simpson N, Classroom-based cognitive behaviour therapy (FRIENDS): a cluster randomised controlled trial to Prevent Anxiety in Children through Education in Schools (PACES), Lancet Psychiatry, 2014, 1, 3, 185-192, doi: 10.1016/S2215-0366(14)70244-5.
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Results
Stallard P, Skryabina E, Taylor G, Anderson R, Ukoumunne OC, Daniels H, Phillips R, Simpson N, A cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of a school-based cognitive–behavioural therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10 years.