Contact information
Type
Scientific
Primary contact
Dr Sean Perrin
ORCID ID
Contact details
Department of Psychology
Box 213 Lund University
Lund
221 00
Sweden
-
sean.perrin@psy.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8202
Study information
Scientific title
Cognitive therapy for generalised anxiety disorder in children and young people: a pilot randomised controlled trial and qualitative investigation of their experience of treatment
Acronym
Study hypothesis
The main aim of this project is to evaluate the effect on symptoms and quality of life of a form of cognitive therapy tageting maintaining factors specific to generalised anxiety disorder (GAD) in children and adolescents. Outcomes for this 10-week, individual, child-focused treatment will be compared to outcomes for participants offered 10 weeks of psychoeducation and self-monitoring of symptoms (delayed treatment). Participants will be randomised to the two conditions. The main hypothesis is that cognitive therapy will be superior to the control intervention in reduction of GAD diagnostic status (primary outcome variable), and self-reported worry frequency, and quality of life. The secondary aims are to evaluate the children's subjective experience of the treatment and changes in cognitions that help to maintain worry.
On 04/02/2014 the anticipated end date was changed from 31/12/2010 to 30/11/2013. Publication of trial findings is expected in 2014.
Ethics approval
1. Royal Free Hospital and Medical School Research Ethics Committee approved on the 3rd December 2009 (ref: 09/H0720/127)
2. KCL/SLaM Research and Development approved on the 12th February 2010 (ref: R&D2010/015)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health Research Network; Subtopic: Anxiety; Disease: Anxiety
Intervention
Intervention: cognitive therapy for GAD as developed by Dugas and Robichaud but adapted for use with pre-pubertal children and adolescents. Treatment will be weekly, individual and child-focused.
Control: single face-to-face session with a therapist wherein the child and the family will be provided with psychoeducation about anxiety and its treatment, symptom monitoring forms, and a date for the first treatment session in 10 weeks time.
Study entry: single randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
GAD diagnostic status, measured with DSM-IV at entry to the trial (pre-treatment), post-treatment (10 weeks) or post-wait/self-monitoring
Secondary outcome measures
1. Worry frequency, measured with Penn State Worry Questionnaire for Children (PSWQ-C)
2. Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire
Measured at baseline, mid-treatment (5 weeks), end of treatment (10 weeks) and at 3-month follow up assessment.
Overall trial start date
01/01/2009
Overall trial end date
30/11/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children/young people aged 10 - 18 years, either sex
2. Diagnosis of GAD according to Diagnostic and Statistical Manual of Mental Disorders, version 4 (DSM-IV) criteria
3. Consecutively referred to a National and Specialist children's anxiety clinic (if they give informed consent)
4. Participants with a comorbid Axis 1 diagnosis will be included provided GAD is the primary disorder in need of treatment
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned sample size: 40; UK sample size: 40
Total final enrolment
40
Participant exclusion criteria
1. Psychosis or learning difficulties (estimated intelligence quotient [IQ] below 70) or autistic spectrum disorder
2. Another mental health problem other than GAD that is more in need of treatment at the time of referral (such as severe depression)
Recruitment start date
01/01/2009
Recruitment end date
30/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lund University
Lund
221 00
Sweden
Sponsor information
Organisation
King's College London (KCL) (UK)
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme (ref: PB-PG-0808-17094)
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list
2019 results in https://link.springer.com/article/10.1007/s10608-019-10020-3 (added 04/06/2019)