Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2012

Open Access 01-12-2012 | Study protocol

School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)

Authors: Paul Stallard, Gordon Taylor, Rob Anderson, Harry Daniels, Neil Simpson, Rhiannon Phillips, Elena Skryabina

Published in: Trials | Issue 1/2012

Login to get access

Abstract

Background

Emotional problems such as anxiety and low mood in children are common, impair everyday functioning and increase the risk of severe mental health disorders in adulthood. Relatively few children with emotional health problems are identified and referred for treatment indicating the need to investigate preventive approaches.

Methods/Design

The study is designed to be a pragmatic cluster randomized controlled trial evaluating the effectiveness of an efficacious school-based cognitive behavior therapy (CBT) prevention program (FRIENDS) on symptoms of anxiety and low mood in children 9 to 10 years of age. The unit of allocation is schools which are assigned to one of three conditions: school-led FRIENDS, health-led FRIENDS or treatment as usual. Assessments will be undertaken at baseline, 6 months and 12 months. The primary outcome measure is change on the Revised Child Anxiety and Depression Scale. Secondary outcome measures assess changes in self-esteem, worries, bullying and life satisfaction. An economic evaluation will be undertaken.

Discussion

As of September 2011, 41 schools have been recruited and randomized. Final 12-month assessments are scheduled to be completed by May 2013.

Trial Registration

ISRCTN23563048
Literature
1.
Costello E, Angold A, Burns BJ, Stangl DK, Tweed DL, Erkanli A, Worthman CM: The Great Smoky Mountains Study of Youth: goals, deigns, methods and prevalence of DSM-iii-R disorders. Arch Gen Psychiatry. 1996, 53: 1129-1136. 10.1001/archpsyc.1996.01830120067012.CrossRefPubMed
2.
Meltzer H, Gatward R, Goodman R, Ford T: Mental health of children and adolescents in Great Britain. Int Rev Psychiatry. 2003, 15: 185-187. 10.1080/0954026021000046155.CrossRefPubMed
3.
Costello EJ, Mustillo S, Erkanli A, Keeler G, Angold A: Prevalence and development of psychiatric disorders in childhood and adolescence. Arch Gen Psychiatry. 2003, 60: 837-844. 10.1001/archpsyc.60.8.837.CrossRefPubMed
4.
Essau CA, Conradt J, Petermann F: Frequency, comorbidity, and psychological impairment of anxiety disorders in German adolescents. J Anxiety Disord. 2000, 14 (3): 263-279. 10.1016/S0887-6185(99)00039-0.CrossRefPubMed
5.
Ferguson DM, Horwood LJ, Ridder EM, Beautrais AL: Sub threshold depression in adolescence and mental health outcomes in adulthood. Arch Gen Psychiatry. 2005, 62: 66-72. 10.1001/archpsyc.62.1.66.CrossRef
6.
Birhamer B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B: Childhood and adolescent depression: a review of the past 10 years. Part 1. J Am Acad Child Adolesc Psychiatry. 1996, 35: 427-439.
7.
Harrington R, Fudge H, Rutter M, Pickles A, Jill J: Adult outcomes of child and adolescent depression. I. Psychiatric Status. Arch Gen Psychiatry. 1990, 47: 465-473. 10.1001/archpsyc.1990.01810170065010.CrossRefPubMed
8.
Kim-Cohen J, Caspi A, Moffitt TE, Harrington H, Milne BJ, Poulton R: Prior Juvenile Diagnoses in Adults with Mental Disorder Developmental Follow-Back of a Prospective-Longitudinal Cohort. Arch Gen Psychiatry. 2003, 60: 709-717. 10.1001/archpsyc.60.7.709.CrossRefPubMed
9.
Woodward LJ, Fergusson DM: Life Course Outcomes of Young People with Anxiety Disorders in Adolescence. J Am Acad Child Adolesc Psychiatry. 2001, 40: 1086-1093. 10.1097/00004583-200109000-00018.CrossRefPubMed
10.
National Institute of Clinical Excellence: Depression in children and young people: identification and management in primary, community and secondary care. 2005, Leicester: British Psychological Society and Royal College of Psychiatrists: National Clinical Practice Guideline, 28
11.
Ford T, Goodman R, Meltzer M: Service use over 18 months among a nationally representative sample of British children with psychiatric disorder. Clin Child Psychol Psychiatry. 2003, 8: 37-51. 10.1177/1359104503008001006.CrossRef
12.
Adi Y, Killoran A, Janmohamed K, Stewart-Brown S: Systematic review of the effectiveness of interventions to promote mental wellbeing in children in primary education. 2007, London: National Institute for Health and Clinical Excellence: Report 1: universal approaches (non-violence related outcomes)
13.
Shucksmith J, Summerbell C, Jones S, Whittaker V: Mental wellbeing of children in primary education (targeted/indicated activities). 2007, London: National Institute for Health and Clinical Excellence
14.
Neil AL, Christensen H: Efficacy and effectiveness of school-based prevention and early intervention programs for anxiety. Clin Psychol Rev. 2009, 29: 208-215. 10.1016/j.cpr.2009.01.002.CrossRefPubMed
15.
Fisak BJ, Richard D, Mann A: The prevention of child and adolescent anxiety: A meta-analytic review. Prev Sci. 2011, 12: 255-268. 10.1007/s11121-011-0210-0.CrossRefPubMed
16.
World Health Organisation: Prevention of Mental Disorders: effective interventions and policy options. 2004, Geneva: WHO
17.
Barrett P, Turner C: Prevention of anxiety symptoms in primary school children: Preliminary results from a universal school-based trial. Br J Clin Psychol. 2001, 40: 399-410. 10.1348/014466501163887.CrossRefPubMed
18.
Lowry-Webster H, Barrett P, Dadds MR: A universal prevention trial of anxiety and depressive symptomatology in childhood: Preliminary data from an Australian study. Behav Change. 2001, 18: 36-50. 10.1375/bech.18.1.36.CrossRef
19.
Lowry-Webster H, Barrett P, Lock S: A universal prevention trial of anxiety symptomatology during childhood: Results at one-year follow-up. Behav Change. 2003, 20: 25-43. 10.1375/bech.20.1.25.24843.CrossRef
20.
Barrett PM, Farrell LJ, Ollendick TH, Dadds M: Long-term outcomes of an Australian universal prevention trial of anxiety and depression symptoms in children and youth: an evaluation of the FRIENDS programme. J Clin Child Adolesc Psychol. 2006, 35: 403-411. 10.1207/s15374424jccp3503_5.CrossRefPubMed
21.
Lock S, Barrett PM: A longitudinal study of developmental differences in a universal preventive intervention for child anxiety. Behav Change. 2003, 20: 183-199. 10.1375/bech.20.4.183.29383.CrossRef
22.
Raab GM, Butcher I: Balance in cluster randomized trial. Stat Med. 2001, 20: 351-365. 10.1002/1097-0258(20010215)20:3<351::AID-SIM797>3.0.CO;2-C.CrossRefPubMed
23.
Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE: Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child and anxiety scale. Behav Res Ther. 2000, 38: 835-855. 10.1016/S0005-7967(99)00130-8.CrossRefPubMed
24.
Spence SH: The Spence Children’s Anxiety Scale (SCAS). Child Psychology Portfolio. Edited by: Sclare I. 1997, Windsor: NFER-Nelson
25.
Chorpita BF, Moffitt CE, Gray J: Psychometric properties of the revised child anxiety and depression scale in a clinical sample. Behav Res Ther. 2005, 43: 309-322. 10.1016/j.brat.2004.02.004.CrossRefPubMed
26.
Muris P, Meesters C, Schouten E: A brief questionnaire of DSM-IV-defined anxiety and depression symptoms among children. Clin Psychol Psychother. 2002, 9: 430-442. 10.1002/cpp.347.CrossRef
27.
Sandin B, Chorot P, Valiente RM, Chorpita BF: Development of a 30 item version of the revised child anxiety and depression scale. Revista de Psicopatologia y Psicologia Clinica. 2010, 15: 165-178.
28.
Rosenberg M: Society and the adolescent self-image. 1965, Princeton, NJ: Princeton University PressCrossRef
29.
Chorpita BF, Tracey SA, Brown TA, Collica TJ, Barlow DH: Assessment of worry in children and adolescents: an adaptation of the Penn State Worry Questionnaire. Behav Res Ther. 1997, 35: 569-581. 10.1016/S0005-7967(96)00116-7.CrossRefPubMed
30.
Goodman R: The Strengths and Difficulties Questionnaire: A Research Note. J Child Psychol Psychiatry. 1997, 38: 581-586. 10.1111/j.1469-7610.1997.tb01545.x.CrossRefPubMed
31.
Goodman R, Scott S: Comparing the Strengths and Difficulties Questionnaire and the Child Behavior Checklist: Is Small Beautiful?. J Abnorm Child Psychol. 1999, 27: 17-24. 10.1023/A:1022658222914.CrossRefPubMed
32.
Ebesutani C, Chorpita BF, Higa-McMillan CK, Nakamura BJ, Regan J, Lynch RE: A psychometric analysis of the revised child anxiety and depression scales - parent version in a school sample. J Abnorm Psychol. 2011, 39: 173-185. 10.1007/s10802-010-9460-8.CrossRef
33.
Stevens K: J. Assessing the performance of a new generic measure of health related quality of life for children and refining it for use in health state valuation. Applied Health Economics and. Health Policy. 2011, 9: 157-169.
34.
Beecham J, Knapp M: Costing psychiatric interventions. Measuring Mental Health Needs. Edited by: Thornicroft G. 2001, London: Gaskell
35.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010, 340: 869-10.1136/bmj.c869.CrossRef
36.
White IR, Horton N, Carpenter J, Pocock SJ: Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011, 342: d40-10.1136/bmj.d40.CrossRefPubMedPubMedCentral
37.
Glick H, Doshi J, Sonnad S, Polsky D: Economic evaluation in clinical trials. 2007, Oxford: Oxford University Press
38.
Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, Reed S: Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force Report. Value Health. 2005, 8: 521-520. 10.1111/j.1524-4733.2005.00045.x.CrossRefPubMed
39.
Gomes M, Grieve R, Nixon R, Edmunds WJ: Statistical methods for cost-effectiveness analyses that use data from cluster-randomised trials: a systematic review and checklist for critical appraisal. Med Decis Making. 2012, 32: 209-220. 10.1177/0272989X11407341.CrossRefPubMed
40.
Goldstein H: Multilevel Statistical Models. 2003, London: Arnold, 3
Metadata
Title
School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)
Authors
Paul Stallard
Gordon Taylor
Rob Anderson
Harry Daniels
Neil Simpson
Rhiannon Phillips
Elena Skryabina
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-227

Other articles of this Issue 1/2012

Trials 1/2012 Go to the issue

Study protocol

Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

Study protocol

Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX): a study protocol for a cluster-randomized controlled trial

Review

Factors contributing to therapeutic effects evaluated in acupuncture clinical trials

Research

Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients

Study protocol

More Active Mums in Stirling (MAMMiS): a physical activity intervention for postnatal women. Study protocol for a randomized controlled trial

Study protocol

Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial