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ISRCTN
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ISRCTN92977593
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ClinicalTrials.gov identifier
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Public title
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Overcoming your child's fears and worries: a self-help guide for childhood anxiety disorders
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Scientific title
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Overcoming your child's fears and worries: a randomised controlled trial of guided self-help for childhood anxiety disorders
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Acronym
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Overcoming
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Serial number at source
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v06.02.2008
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Study hypothesis
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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)?
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Lay summary
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Lay summary under review
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Ethics approval
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Berkshire Research Ethics Committee approved on 16 November 2007, ref: 07/H0505/157
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Child anxiety disorder
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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25/04/2008
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Anticipated end date
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30/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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195
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Interventions
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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)
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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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
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Sources of funding
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Medical Research Council (MRC) (UK) (ref: G0802326)
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Trial website
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Publications
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Contact name
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Prof
Peter
Cooper
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Address
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School of Psychology and Clinical Language Sciences
University of Reading
Reading
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City/town
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Berkshire
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Zip/Postcode
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RG6 6AL
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Country
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United Kingdom
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Sponsor
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University of Reading (UK)
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Address
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c/o Dr M J Proven
Research and Enterprise Services
Reading
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City/town
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Berkshire
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Zip/Postcode
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RG6 6AL
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Country
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United Kingdom
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Sponsor website:
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http://www.reading.ac.uk
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Date applied
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06/10/2011
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Last edited
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22/11/2011
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Date ISRCTN assigned
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22/11/2011
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