Condition category
Mental and Behavioural Disorders
Date applied
13/09/2010
Date assigned
06/10/2010
Last edited
03/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Stallard

ORCID ID

Contact details

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

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 measures

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

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

http://www.awp.nhs.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes

03/11/2016: Publication reference added.