Overcoming your child's fears and worries: a self-help guide for childhood anxiety disorders
| ISRCTN | ISRCTN92977593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92977593 |
| Secondary identifying numbers | v06.02.2008 |
- Submission date
- 06/10/2011
- Registration date
- 22/11/2011
- Last edited
- 03/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Anxiety problems in childhood are common and can cause problems at home, in school and with friendships. Talking treatments based on cognitive-behaviour therapy (CBT) for childhood anxiety problems are known to work well in many cases, but accessing trained therapists can be difficult. We aim to investigate results obtained following two forms of guided CBT self-help, delivered via parents, in comparison to results of a wait list control group (the control group does not receive CBT).
Who can participate?
Participants are children aged 7-12 years referred to Berkshire Child Anxiety Clinic from across Berkshire (UK), who are experiencing significant anxiety problems (and meet criteria for an anxiety disorder) and their parent(s)/carer(s).
What does the study involve?
We are comparing two versions of the guided CBT self-help intervention (full and less intense) to a wait-list control group. The full version involves four face to face sessions with a therapist and four telephone review sessions; the less intense version involves two face to face and two telephone review sessions. The content of the sessions focuses in helping parents to help their child overcome their fears and worries using cognitive-behavioural principles.
What are the possible benefits and risks of participating?
Many children are expected to make significant gains in relation to their anxiety difficulties. No side-effects from treatment are anticipated.
Where is the study run from?
The Berkshire Child Anxiety Clinic, a joint service delivered across Berkshire (UK), by Berkshire Healthcare NHS Foundation Trust and the University of Reading.
When is the study starting and how long is it expected to run for?
The study started in April 2008 and the anticipated end date is December 2012.
Who is funding the study?
National Institute of Health Research, Research for Patient Benefit (UK).
Who is the main contact?
Professor Peter Cooper
p.j.cooper@reading.ac.uk
Contact information
Scientific
School of Psychology and Clinical Language Sciences
University of Reading
Reading
Berkshire
RG6 6AL
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Overcoming your child's fears and worries: a randomised controlled trial of guided self-help for childhood anxiety disorders |
| Study acronym | Overcoming |
| Study objectives | In a randomised controlled trial of childhood anxiety (in the absence of a current maternal anxiety disorder) the principal research questions are: 1. Does full guided self-help CBT lead to a reduction in anxiety disorder diagnoses, in comparison to a wait-list control? 2. Does less intense guided self-help CBT lead to a reduction in anxiety disorder diagnoses, in comparison to a wait-list control? Secondary research questions: 3. Does full guided self-help Cognitive behaviour therapy (CBT) lead to a reduction in anxiety symptoms, in comparison to a wait-list control? 4. Does less intense guided self-help CBT lead to a reduction in anxiety symptoms, in comparison to a wait-list control? 5. Are specific parenting practices (over involvement, fear expression) and thinking styles (expectations about child competency) associated with child treatment outcome (symptoms/ diagnosis)? |
| Ethics approval(s) | Berkshire Research Ethics Committee approved on 16 November 2007, ref: 07/H0505/157 |
| Health condition(s) or problem(s) studied | Child anxiety disorder |
| Intervention | Guided Cognitive Behaviour Therapy (CBT) self-help delivered via parents: 1. 8 sessions (4 face to face, 4 telephone) 2. 4 sessions (2 face to face, 2 telephone) |
| Intervention type | Other |
| Primary outcome measure | 1. Clinical Global Impressions of Improvement (CGI-I) (Much / Very much improved or not) 2. Anxiety Disorders Interview Schedule for DSM IV (child and parent versions) (ADIS-C/P) (Child free of primary anxiety disorder or not) |
| Secondary outcome measures | 1. Child anxiety symptoms and impact (SCAS, Spence, 1998- child/parent/teacher report; CAIS, Langley et al., 2004 - child/parent report) 2. Parental interactive behaviours and cognitions as assessed by interview and observations |
| Overall study start date | 25/04/2008 |
| Completion date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 195 |
| Key inclusion criteria | 1. Aged 7 to 12 years 2. Primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) generalised anxiety disorder, social phobia, separation anxiety disorder, panic disorder/agoraphobia or specific phobia 3. Parent / primary carer attends treatment |
| Key exclusion criteria | Child: 1. Significant physical or intellectual impairment (including autistic spectrum disorders) 2. Current prescription of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study) Parent(s): 1. Current maternal DSM-IV anxiety disorder 2. Significant intellectual impairment 3. Severe comorbid disorder (e.g. severe major depressive disorder, psychosis, substance /alcohol dependence) 4. Prescription of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least one month with agreement to maintain that dose throughout the study) |
| Date of first enrolment | 25/04/2008 |
| Date of final enrolment | 30/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
RG6 6AL
United Kingdom
Sponsor information
Research organisation
c/o Dr M J Proven
Research and Enterprise Services
Reading
Berkshire
RG6 6AL
United Kingdom
| Website | http://www.reading.ac.uk |
|---|---|
"ROR" |
https://ror.org/05v62cm79 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No |
