Preventing Anxiety in Children through Education in Schools

ISRCTN	ISRCTN23563048
DOI	https://doi.org/10.1186/ISRCTN23563048
Protocol serial number	NIHR/PHR/09/3000/03
Sponsor	Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Funder	Public Health Research Programme (ref: 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

Department for Health
22-23 Eastwood
University of Bath
Bath
BA2 7AY
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled cluster trial
Secondary study design	Cluster randomised trial
Study type	Participant 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(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.
Key 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.
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	9 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	1080
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

United Kingdom
England

Study participating centre

University of Bath

Bath
BA2 7AY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2014		Yes	No
Results article	results	01/11/2015		Yes	No
Results article	results	01/11/2016		Yes	No
Protocol article	protocol	27/11/2012		Yes	No
Protocol article	24-month follow-up protocol	13/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/11/2016: Publication reference added.