Cognitive behavioural treatment of children and adolescents with anxiety disorders: optimising treatment based on patient characteristics

ISRCTN	ISRCTN48511871
DOI	https://doi.org/10.1186/ISRCTN48511871
Protocol serial number	5484 (NFGV); NTR347
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funders	Leiden University Medical Centre (LUMC) (The Netherlands) - Revolving Fund, National Fund for Public Mental Health (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (The Netherlands), Sophia Foundation for Scientific Research (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Adelinde J.M. van der Leeden
Scientific

Academisch Centrum Kinder - en Jeugdpsychiatrie Curium
Endegeesterstraatweg 27
Oegstgeest
2342 AK
Netherlands

Phone	+31 (0)71 515 9600
Email	A.J.M.van.der.Leeden@umail.leidenuniv.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Group cognitive behavioural treatment is as effective as individual cognitive behavioural treatment 2. Treatment outcome is predicted by severity of the psychopathology, cognitive variables, social variables, biological variables and environmental variables 3. Children diagnosed with an anxiety disorder after the first phase of treatment will respond to prolongation of the treatment with active participation of parents
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Anxiety disorders
Intervention	1. Individual cognitive behavioural treatment 2. Group cognitive behavioural treatment
Intervention type	Other
Primary outcome measure(s)	1. Diagnostic status 2. Anxiety symptoms
Key secondary outcome measure(s)	1. Depressive symptoms 2. Other symptoms of psychopathology 3. Global level of functioning
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	180
Key inclusion criteria	1. Children and adolescents between 8 and 16 years old 2. Primary diagnosed with at least one of following Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV) anxiety disorders: separation anxiety disorder, social phobia, generalised anxiety disorder or specific phobia
Key exclusion criteria	1. Intelligence Quotient (IQ) less than 85 2. Children who are not proficient in the Dutch language 3. Somatic disease 4. Drug related disorder 5. Pervasive developmental disorder 6. Selective mutism 7. Psycho-somatic disease 8. Schizophrenia or other psychotic disorder 9. Obsessive compulsive disorder 10. Post-traumatic stress disorder 11. Acute stress disorder 12. Use of medication for anxiety 13. Concurrent psychotherapy
Date of first enrolment	01/09/2002
Date of final enrolment	01/12/2006

Academisch Centrum Kinder - en Jeugdpsychiatrie Curium

Oegstgeest
2342 AK
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No