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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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20 February 2023 |
Main ID: |
ISRCTN88636606 |
Date of registration:
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15/01/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Feasibility trial of open-access psychological workshops in schools
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Scientific title:
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Early Intervention for Depression and Anxiety in 16-18 year olds: a Feasibility Trial of Open-Access Psychological Workshops in Schools |
Date of first enrolment:
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17/10/2014 |
Target sample size:
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150 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN88636606 |
Study type:
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Interventional |
Study design:
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Randomised; Interventional (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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June
Brown |
Address:
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King's College London
London Institute Of Psychiatry
16 De Crespigny Park
SE5 8AF
London
United Kingdom |
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Key inclusion & exclusion criteria
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Inclusion criteria: Young people aged between 16 and 18, attending a recruited school or college in Southwark or Lambeth, who are fluent in English, are able to attend the workshops and would like psychological help for managing emotional difficulties. Eligibility criteria: 1. Aged 16 – 18 years old 2. Attending a recruited school or college in Southwark or Lambeth 3. Fluent in English 4. Wanting psychological help for managing emotional difficulties 5. Able to attend the workshop
Exclusion criteria: Young people who are identified as being at acute risk of harm to themselves or others, who have severe learning difficulties, are unable to complete the assessment and consent forms and are unable to attend the workshop information meetings. Exclusion criteria 1. People identified as being at acute risk of harm to themselves or others 2. Severe learning difficulties 3. Unable to complete the assessment and consent forms 4. Unable to attend the workshop information meetings
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Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Mental Health; Subtopic: Anxiety, Depression; Disease: Depression, Anxiety Mental and Behavioural Disorders
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Intervention(s)
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A day long workshop titled ’How to Handle Stress’. Materials are organised into short sections and delivered over the course of six hours (with breaks). This includes introductions, ice breakers, an explanation of the CBT model, and the introduction and practice of CBT techniques. Particular attention is given to personal, relationship and academic stresses typical for the age group. Behavioural methods include techniques such as problem-solving and time management. Cognitive methods include becoming aware of negative thoughts and learning to challenge unhelpful ones. Workshops will be run in a quiet room in schools and will be facilitated by two clinical psychologists and an assistant according to a detailed manual with a fidelity checklist. The workshops aim to provide the students who attend with the theory and strategies to help to build resilience to stress and build their capacity to resolve problems. After the workshop participants will be helped to set personal goals, which will be discussed and progress reviewed in a follow-up phone call with one of the workshop leaders, one week after the workshop.
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Primary Outcome(s)
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The Mood and Feelings Questionnaire (MFQ; Costello & Angold, 1988).; Timepoint(s): T1 (baseline), T3 (3-month follow-up), T5 (6-month follow-up)
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Secondary Outcome(s)
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1. The Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al 2000) is a 47-item self-report measure. The child version has been shown to have good construct validity, internal consistency, and test-re-test reliability (T1, T3, T5). 2. The Paediatric Quality of Life Enjoyment and Satisfaction Form (PQ-LES-Q; Endicott et al, 2006) is a 15-item self-report questionnaire. Items are scored on a 1-5 point likert scale. It has been found to have high internal consistency and test-retest reliability (T1, T3, T5). 3. The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS, Tennant et al., 2007) is a measure of mental wellbeing and consists of 14 positively worded items with five response categories. The scale was initially designed to assess mental wellbeing in adults, but a recent report from the WAVES Project, reported on its suitability with secondary school children aged 13 and over (T1, T3, T5). 4. Sociodemographic proforma: Information on date of birth, gender and ethnicity will also be obtained (T1 only). 5. The Client Service Receipt Inventory (CSRI, Beecham and Knapp 2001) is a self-report measure of service use. A short version covering a retrospective 3-month period will be specially developed and adapted for use with this group of students. Participants will be asked to provide information about contacts with general health services, mental health services, charities and education support as well as informal help received from carers and friends (T1 and T3). 6. The EQ-5D (The EuroQol Group 1990) is a self-report measure of health-related quality of life, on five dimensions (mobility, self-care, usual activities, pain / discomfort, anxiety / depression). In addition, participants are asked to rate their current health on a scale from 0-100 (worst to best). The instrument allows for the calculation of quality-adjusted life years (QALYs) (T1 and T3).
Timepoints: T1 (baseline), T3 (3-month follow-up), T5 (6-month follow-up).
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Source(s) of Monetary Support
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National Institute for Health Research
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Ethics review
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Status:
Approval date:
Contact:
14/LO/1416; First MREC approval date 18/09/2014
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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08/06/2016 |
URL:
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