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Trials
Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE)

Authors: Paul Stallard, Alan A Montgomery, Ricardo Araya, Rob Anderson, Glynn Lewis, Kapil Sayal, Rhiannon Buck, Abigail Millings, John A Taylor

Published in: Trials | Issue 1/2010

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Abstract

Background

Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches.

Study Design

A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16). The unit of allocation is year groups (n = 28) which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm.

Discussion

As of August 2010, all 28 year groups (n = 5023) had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011.

Trial Registration

ISRCTN19083628
Appendix
Available only for authorised users
Literature
1.
Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE: Childhood and adolescent depression: A review of the past 10 years. Part 1. Journal of the American Academy of Child and Adolescent Psychiatry. 1996, 35 (11): 1427-39. 10.1097/00004583-199611000-00011.CrossRefPubMed
2.
Merry S, McDowell H, Hetrick S, Bir J, Muller N: Psychological and/or educational interventions for the prevention of depression in children and adolescents. Cochrane Database Syst Rev. 2004, CD003380-1
3.
Harrington R, Fudge H, Rutter M, Pickles A, Hill J: Adult outcomes of child and adolescent depression, Part1: Psychiatric status. Archives of General Psychiatry. 1990, 47 (5): 465-73.CrossRefPubMed
4.
Lewinsohn PM, Clarke GN: Psychosocial treatments for adolescent depression. Clinical Psychology Review. 1999, 19 (3): 329-42. 10.1016/S0272-7358(98)00055-5.CrossRefPubMed
5.
Vernberg EM: Psychological adjustment and experiences with peers during early adolescence-reciprocal, incidental, or unidirectional relationships. Journal of Abnormal Child Psychology. 1990, 18 (2): 187-98. 10.1007/BF00910730.CrossRefPubMed
6.
Fergusson DM, Horwood LJ, Ridder EM, Beautrais AL: Subthreshold depression in adolescence and mental health outcomes in adulthood. Archives of General Psychiatry. 2005, 62 (1): 66-72. 10.1001/archpsyc.62.1.66.CrossRefPubMed
7.
National Institute of Clinical Excellence: Depression in children and young people: identification and management in primary, community and secondary care. National Clinical Practice Guideline 28. 2005, Leicester: British Psychological Society and Royal College of Psychiatrists
8.
Logan DE, King CA: Parental identification of depression and mental health service use among depressed adolescents. Journal of the American Academy of Child and Adolescent Psychiatry. 2002, 41 (3): 296-304. 10.1097/00004583-200203000-00009.CrossRefPubMed
9.
Moor S, Maguire A, McQueen H, Wells JE, Elton R, Wrate R: Improving the recognition of depression in adolescence: Can we teach the teachers?. Journal of Adolescence. 2007, 30 (1): 81-95. 10.1016/j.adolescence.2005.12.001.CrossRefPubMed
10.
Calear AL, Christensen H: Systematic review of school-based prevention and early intervention programs for depression. Journal of Adolescence. 2010, 33 (3): 429-438. 10.1016/j.adolescence.2009.07.004.CrossRefPubMed
11.
Giesen F, Searle A, Sawyer M: Identifying and implementing prevention programmes for childhood mental health problems. Journal of Paediatrics and Child Health. 2007, 43: 785-789. 10.1111/j.1440-1754.2007.01196.x.CrossRefPubMed
12.
Clarke GN, Hawkins W, Murphy M, Sheeber LB, Lewinsohn PM, Seeley JR: Targeted prevention of unipolar depressive disorder in an at-risk sample of high-school adolescents - A randomized trial of group cognitive intervention. Journal of the American Academy of Child and Adolescent Psychiatry. 1995, 34 (3): 312-21. 10.1097/00004583-199503000-00016.CrossRefPubMed
13.
Spence SH, Sheffield JK, Donovan CL: Preventing adolescent depression: An evaluation of the problem solving for life program. Journal of Consulting and Clinical Psychology. 2003, 71 (1): 3-13. 10.1037/0022-006X.71.1.3.CrossRefPubMed
14.
Shochet IM, Dadds MR, Holland D, Whitefield K, Harnett PH, Osgarby SM: The efficacy of a universal school-based program to prevent adolescent depression. Journal of Clinical Child Psychology. 2001, 30 (3): 303-15. 10.1207/S15374424JCCP3003_3.CrossRefPubMed
15.
Horowitz JL, Garber J: The prevention of depressive symptoms in children and adolescents: a meta-analytic review. Journal of Consulting and Clinical Psychology. 2006, 74 (3): 401-415. 10.1037/0022-006X.74.3.401.CrossRefPubMed
16.
Brown C, Liao J: Principles for designing randomised preventive trials in mental health: an emerging developmental epidemiology paradigm. American Journal of Community Psychology. 1999, 27 (5): 673-710. 10.1023/A:1022142021441.CrossRefPubMed
17.
Rose G: The strategy of preventative medicine. 1992, New York: Oxford University Press
18.
Spence SH, Shortt AL: Research review: can we justify the widespread dissemination of universal, school based interventions for the prevention of depression amongst children and adolescents?. Journal of Child Psychology and Psychiatry. 2007, 48 (6): 526-542. 10.1111/j.1469-7610.2007.01738.x.CrossRefPubMed
19.
Shochet IM, Dadds MR, Holland D, Whitefield K, Harnett PH, Osgarby SM: The efficacy of a universal school-based program to prevent adolescent depression. Journal of Clinical Child Psychology. 2001, 30 (3): 303-15.
20.
Merry S, McDowell H, Wild CJ, Bir J, Cunliffe R: A randomized placebo-controlled trial of a school-based depression prevention program. Journal of the American Academy of Child and Adolescent Psychiatry. 2004, 43 (5): 538-47. 10.1097/00004583-200405000-00007.CrossRefPubMed
21.
Shochet I, Ham D: Universal school-based approaches to preventing adolescent depression: past findings and future directions of the Resourceful Adolescent Program. International Journal of Mental Health Promotion. 2004, 6 (3): 17-25.CrossRef
22.
Raab GM, Butcher I: Balance in cluster randomized trials. Statistics in Medicine. 2001, 20 (3): 351-65. 10.1002/1097-0258(20010215)20:3<351::AID-SIM797>3.0.CO;2-C.CrossRefPubMed
23.
Angold A, Costello E, Messer S, Pickles A, Winder F, Silver D: Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. International Journal of Methods in Psychiatric Research. 1995, 5: 237-49.
24.
Kent L, Vostanis P, Feehan C: Detection of major and minor depression in children and adolescents: Evaluation of the mood and feelings questionnaire. Journal of Child Psychology and Psychiatry and Allied Disciplines. 1997, 38 (5): 565-73. 10.1111/j.1469-7610.1997.tb01543.x.CrossRef
25.
Thapar A, McGuffin P: Validity of the shortened mood and feelings questionnaire in a community sample of children and adolescents: a preliminary research note. Psychiatry Research. 1998, 81 (2): 259-68. 10.1016/S0165-1781(98)00073-0.CrossRefPubMed
26.
Angold A, Erkanli A, Silberg J, Eaves L, Costello EJ: Depression scale scores in 8-17-year-olds: effects of age and gender. Journal of Child Psychology and Psychiatry and Allied Disciplines. 2002, 43 (8): 1052-63. 10.1111/1469-7610.00232.CrossRef
27.
Shapiro A, Shapiro E: The powerful placebo; from ancient priest to modern physician. 1997, Baltimore: John Hopkins University Press
28.
Costello EJ, Benjamin R, Angold A, Silver D: Mood variability in adolescents - a study of depressed, nondepressed and comorbid patients. Journal of Affective Disorders. 1991, 23 (4): 199-212. 10.1016/0165-0327(91)90101-W.CrossRefPubMed
29.
Messer SC, Angold A, Costello EJ, Loeber R, VanKammen W, StouthamerLoeber M: Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents: Factor composition and structure across development. International Journal of Methods in Psychiatric Research. 1995, 5 (4): 251-62.
30.
Sharp C, Goodyer IM, Croudace TJ: The Short Mood and Feelings Questionnaire (SMFQ): A unidimensional item response theory and categorical data factor analysis of self-report ratings from a community sample of 7-through 11-year-old children. Journal of Abnormal Child Psychology. 2006, 34 (3): 379-91. 10.1007/s10802-006-9027-x.CrossRefPubMed
31.
Schniering CA, Rapee RM: Development and validation of a measure of children's automatic thoughts: the children's automatic thoughts scale. Behaviour Research and Therapy. 2002, 40 (9): 1091-109. 10.1016/S0005-7967(02)00022-0.CrossRefPubMed
32.
Rosenberg M: Society and the adolescent self-image. 1965, Princeton, NJ: Princeton University PressCrossRef
33.
Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE: Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behaviour Research and Therapy. 2000, 38 (8): 835-55. 10.1016/S0005-7967(99)00130-8.CrossRefPubMed
34.
Goodenow C: The psychological sense of school membership among adolescents: scale developments and educational correlates. Psychology in the Schools. 1993, 30: 79-90. 10.1002/1520-6807(199301)30:1<79::AID-PITS2310300113>3.0.CO;2-X.CrossRef
35.
Sharpe TM, Killen JD, Bryson SW, Shisslak CM, Estes LS, Gray N: Attachment style and weight concerns in preadolescent and adolescent girls. International Journal of Eating Disorders. 1998, 23 (1): 39-44. 10.1002/(SICI)1098-108X(199801)23:1<39::AID-EAT5>3.0.CO;2-2.CrossRefPubMed
36.
Beecham J, Knapp M: Costing psychiatric interventions. Measuring Mental Health Needs. Edited by: Thorncroft G. 2001, London. Gaskell
37.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ: CONSORT explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010, 340: c869-10.1136/bmj.c869.CrossRefPubMedPubMedCentral
38.
Dunn G, Mohammad M, Tomenson B: Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res. 2005, 14: 369-10.1191/0962280205sm403oa.CrossRefPubMed
Metadata
Title
Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE)
Authors
Paul Stallard
Alan A Montgomery
Ricardo Araya
Rob Anderson
Glynn Lewis
Kapil Sayal
Rhiannon Buck
Abigail Millings
John A Taylor
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-114

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