Guided self-help for childhood anxiety problems: a comparison with usual care
| ISRCTN | ISRCTN07627865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07627865 |
| Secondary identifying numbers | 11481 |
- Submission date
- 13/03/2012
- Registration date
- 13/03/2012
- Last edited
- 22/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
c.creswell@reading.ac.uk
Contact information
Scientific
University of Reading
Winnicott Research Unit
School of Psychology
PO Box 238
Reading
RG6 6AL
United Kingdom
| e.m.white@reading.ac.uk |
Study information
| Study design | Randomised interventional treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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(s) | 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 |
| Condition | Anxiety |
| Intervention | 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 | Behavioural |
| 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 study start date | 01/02/2012 |
| Overall study end date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 136; UK Sample Size: 136 |
| 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 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 | 23/03/2012 |
| Recruitment end date | 31/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
RG6 6AL
United Kingdom
Sponsor information
University/education
Whiteknights
PO Box 217
Berkshire
Reading
RG6 6AH
England
United Kingdom
| Website | http://www.reading.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/05v62cm79 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 17/05/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | Yes | No |
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.
