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Preventing Anxiety in Children through Education in Schools
ISRCTN ISRCTN23563048
DOI 10.1186/ISRCTN23563048
ClinicalTrials.gov identifier
EudraCT number
Public title Preventing Anxiety in Children through Education in Schools
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
Serial number at source NIHR/PHR/09/3000/03
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]).
Lay summary Not provided at time of registration
Ethics approval The University of Bath, School Research Ethics Approval Panel approved on the 28th July 2010 (ref: PACES/SREAP)
Study design Randomised controlled cluster trial
Countries of recruitment United Kingdom
Disease/condition/study domain Anxiety
Participants - inclusion criteria All children aged 9 - 10 years (years 4 and 5) attending study schools (n = 54) and participating in PSHE lessons
Participants - 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.
Anticipated start date 01/01/2011
Anticipated end date 31/12/2013
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 1080 children attending 54 schools
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (ref: 09/3000/03)
Trial website
Publications 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
Contact name Prof  Paul  Stallard
  Address Department for Health
22-23 Eastwood
University of Bath
  City/town Bath
  Zip/Postcode BA2 7AY
  Country United Kingdom
Sponsor Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
  Address Jenner House
Langley Park Estate
Wiltshire
  City/town Chippenham
  Zip/Postcode SN15 1GG
  Country United Kingdom
  Sponsor website: http://www.awp.nhs.uk/
Date applied 13/09/2010
Last edited 20/05/2014
Date ISRCTN assigned 06/10/2010
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