Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Anxiety problems in childhood are common and can cause difficulties at home, in school and with friendships. We want to compare 2 treatments for children with anxiety problems, a talking treatment called 'guided Cognitive Behavioural Therapy (CBT) self-help for parents’, with a common treatment that children receive primary care services called ‘Solution Focused Brief Therapy (SFBT)’, to see which works best to help children become less anxious, and which treatment is most cost-effective.

Who can participate?
Participants are children aged 5-12 years referred to the Primary Child and Adolescent Mental Health Services (PCAMHS) from across Oxfordshire, UK, who are experiencing significant anxiety problems and their parent(s)/carer(s).

What does the study involve?
There is an initial visit with a researcher to talk to both the child and parents. If the child's main problem is anxiety, the child is allocated randomly to 1 of the 2 treatment groups. For both groups the treatment sessions will take place over 8 weeks. Treatment of childen in the guided CBT self-help group involves four face to face sessions with a therapist and four telephone review sessions, all with the parents, and the treatment in the Solution Focused Brief Therapy involves an initial and a final session with a therapist and child and parents, and 4 sessions in between with just the therapist and child. There are 2 further assessments after treatment (one just after treatment and another 6 months later) with a researcher to see how effective the treatment has been. All sessions take place in the family home unless this is difficult, in which case an alternative site is found.

What are the possible benefits and risks of participating?
Many children are expected to significantly reduce their anxiety levels. No side-effects from treatment are anticipated.

Where is the study run from?
The study involves all the 4 PCAMHS teams in Oxfordshire which are based at Banbury, Abingdon, Witney and Oxford city centre, and also the School of Psychology and Clinical Language Sciences at the University of Reading.

When is the study starting and how long is it expected to run for?
December 2011 to December 2013

Who is funding the study?
National Institute of Health Research - Research for Patient Benefit (UK)

Who is the main contact?
Dr Cathy Creswell

Trial website

Contact information



Primary contact

Ms Elizabeth White


Contact details

University of Reading
Winnicott Research Unit
School of Psychology
PO Box 238
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The treatment of child anxiety in primary care via guided CBT self-help: a randomised controlled trial


Study hypothesis

The study is a randomised controlled trial to evaluate the efficacy and cost-effectiveness of guided CBT self-help for child anxiety within PCAMHS across Oxfordshire. Participants, parents of clinically anxious children aged 5-12 years, will be randomly allocated to either the guided CBT self-help condition or to PCAMHS standard care (SFBT) in order to establish whether the guided CBT self-help approach offers benefits in comparison to the intervention families usually receive within PCAMHS. The study will assess whether guided CBT self-help delivers improved outcomes (i.e., reduction of symptoms) in comparison to standard care; whether these differences are maintained six months post-treatment, and whether self-help significantly lowers the costs associated with child anxiety.

Ethics approval

1. NHS Health Research Authority, South Central - Berkshire, 21/11/2011, ref: 11/SC/0472
2. The University of Reading Ethics Committee, 27/01/2012

Study design

Randomised interventional treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet




Guided CBT Self-help versus Solution Focused Brief Therapy (SFBT)

1. Guided CBT Self-help
Parents will be given a self-help book to work through and parents will have 4 face-to-face sessions with a therapist and 4 telephone sessions over an 8 week period, with a total of 5 hours of therapist contact.
2. Solution Focused Brief Therapy (SFBT) involving an initial and a final face-to-face session with the parents and child and 4 sessions in between with the child, totalling 5 hours of therapist contact. Both groups will be reassessed after the completion of treatment and at 6 months post-treatment.

Intervention type



Drug names

Primary outcome measure

The primary indicator of recovery is that the child's difficulties with anxiety are 'much' or 'very much' improved on the basis of clinical global impression as assessed post-treatment by an independent assessor, blind to treatment group and trained to a high level of reliability in the use of the measure.

Secondary outcome measures

Anxiety severity is assessed using the ADIS with parent and child and self-report questionnaires of anxiety symptoms, and the impact of anxiety on the child's life.
The outcome measure for cost-effectiveness will be the improvement status (much/very much improved), as well as a measure of 'days off school avoided' and generic quality of life as assessed by the child friendly EuroQol EQ-5D and CHU9D-c/p.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Children aged 5-12 years meeting standard PCAMHS criteria and with anxiety associated with clinical impairment as the primary presenting problem.

Participant type


Age group




Target number of participants

Planned Sample Size: 136; UK Sample Size: 136

Participant exclusion criteria

1. Current prescription of psychotropic medication, or if psychotropic medication is prescribed, it should have been at a stable dose for at least 8 weeks prior to the study with agreement to maintain that dose throughout the study. If it is considered that a medication change is needed in the interests of the child, this child will no longer be eligible but will still be able to receive the usual treatment from PCAMHS.
2. The child or parent has a poor understanding of the English language.
3. The child or parent has a known physical or intellectual impairment (including autistic spectrum disorder).

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Reading
United Kingdom

Sponsor information


University of Reading (UK)

Sponsor details

PO Box 217
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21190

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The results will be published on 17/05/2017.

IPD sharing plan
The datasets generated during and/or analysed during the current study will be stored in the University of Reading data repository.

Intention to publish date


Participant level data

Stored in repository

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

22/05/2017: Publication reference added. 10/05/2017: The recruitment start date was changed from 01/03/2012 to 23/03/2012. 14/03/2016: The overall trial end date was changed from 30/11/2013 to 31/01/2015.