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
Secondary identifying numbers	5484 (NFGV); NTR347

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

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. Diagnostic status 2. Anxiety symptoms
Secondary outcome measures	1. Depressive symptoms 2. Other symptoms of psychopathology 3. Global level of functioning
Overall study start date	01/09/2002
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	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

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/
"ROR"	https://ror.org/027bh9e22

Hospital/treatment centre

Leiden University Medical Centre (LUMC) (The Netherlands) - Revolving Fund

No information available

National Fund for Public Mental Health (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (The Netherlands)

No information available

Sophia Foundation for Scientific Research (The Netherlands)

No information available

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

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