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Main
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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN13721202 |
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Date of registration:
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17/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The FRIENDS Programme: an evaluation of academic and emotional health outcomes
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Scientific title:
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Evaluating the efficacy of the FRIENDS programme in improving academic attainment and emotional health in primary-aged children in England: a cluster-randomised control trial |
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Date of first enrolment:
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01/01/2016 |
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Target sample size:
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3300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN13721202 |
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Study type:
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Interventional |
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Study design:
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Cluster-randomised control trial (Prevention)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Michael
Wigelsworth |
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Address:
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University of Manchester
A6.3 Ellen Wilkinson Building
Oxford Road
M13 9PL
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 306 1763 |
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Email:
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Michael.wigelsworth@manchester.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Born between 01/09/2004 and 31/08/2005 (within school year 5 for the 2015/2016 academic cohort)
2. Attending a mainstream state-funded primary school within Kent Local Authority
3. Primary school has not previously delivered FRIENDS
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Worry, anxiety, depression
Mental and Behavioural Disorders
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Intervention(s)
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We will be approaching approximately 80 schools to participate in the research. The trial will be cluster-randomised, utilising matched-pair randomisation at the class level (utilising Key Stage 1 and baseline anxiety/depression scores for minimisation). Within each school, we will randomly allocate half of the year 5 classes to an intervention group and half of the year 5 classes to a comparison group. (This will mean that for most schools, one year 5 class will participate in FRIENDS, and one will continue as normal. Some smaller schools where there is only one year 5 class, will either receive the FRIENDS curriculum or a cash incentive instead).
The FRIENDS programme consists of 10 weekly sessions, which aim to promote various protective factors, such as recognising physiological symptoms (e.g. session 2), emotional self-management (e.g. session 4), and supporting peer relationships (e.g. session 8). Indeed, the name of the programme is designed to help pupils recall and utilise the various skills taught in the sessions (Feelings; Remember to Relax; Inner helpful thoughts; Explore solutions and coping plans; Now reward yourself; Do it every day; Stay strong inside). Each session is designed to last 60-75 minutes, but can also be conducted over two 30-35 minute periods instead. Additionally, there are two booster sessions that can be held approximately 1 to 3 months after completing the program, and two information sessions for parents of approximately 2 hours length each. There have been significant revisions in the most recent editions of the FRIENDS programs (Barrett, Cooper, Guajardo, 2014), which now includes increased focus on addressing externalising symptoms.
Throughout various updates in content, the theoretical model underpinning FRIENDS can be consistently described as Cognitive Behaviour Therapy (CBT). The programme therefore teaches children skills in the cognitive (identify and challenge anxiety increasing cognitions), emotional (identify an
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Primary Outcome(s)
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1. Academic Attainment (as measured by combined Key Stage 2 English and Maths scores) - July 2016
2. Self-rated worry (as measured by the Penn State Worry Questionnaire for Children (PSWQ-C) - Jan-Mar 2016/December 2016
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Secondary Outcome(s)
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1. Anxiety & depression (as measured by the Revised Children's Anxiety and Depression Scale (RCADS-30)) - Jan-Mar 2016/December 2016
2. Wellbeing (as measured by the Kidscreen 27) - Jan-Mar 2016/December 2016
3. Health-related quality of life (as measured by the Child Health Utility D9) - Jan-Mar 2016/December 2016
4. Teacher-rated difficulties (as measured by the Strengths and Difficulties Questionnaire (SDQ)) - Jan-Mar 2016/December 2016
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Source(s) of Monetary Support
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Educational Endowment Foundation (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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