Condition category
Mental and Behavioural Disorders
Date applied
06/10/2011
Date assigned
22/11/2011
Last edited
03/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Cooper

ORCID ID

Contact details

School of Psychology and Clinical Language Sciences
University of Reading
Reading
Berkshire
RG6 6AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v06.02.2008

Study information

Scientific title

Overcoming your child's fears and worries: a randomised controlled trial of guided self-help for childhood anxiety disorders

Acronym

Overcoming

Study hypothesis

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

Berkshire Research Ethics Committee approved on 16 November 2007, ref: 07/H0505/157

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

25/04/2008

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

195

Participant 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)

Recruitment start date

25/04/2008

Recruitment end date

30/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology and Clinical Language Sciences
Berkshire
RG6 6AL
United Kingdom

Sponsor information

Organisation

University of Reading (UK)

Sponsor details

c/o Dr M J Proven
Research and Enterprise Services
Reading
Berkshire
RG6 6AL
United Kingdom

Sponsor type

Research organisation

Website

http://www.reading.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK) (ref: G0802326)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2013 results in: www.ncbi.nlm.nih.gov/pubmed/23969483

Publication citations

  1. Results

    Thirlwall K, Cooper PJ, Karalus J, Voysey M, Willetts L, Creswell C, Treatment of child anxiety disorders via guided parent-delivered cognitive-behavioural therapy: randomised controlled trial., Br J Psychiatry, 2013, 203, 6, 436-444, doi: 10.1192/bjp.bp.113.126698.

Additional files

Editorial Notes