Condition category
Mental and Behavioural Disorders
Date applied
30/06/2010
Date assigned
30/06/2010
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

Department of Psychology
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

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0808-17094)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator