Evidence Based Intervention Change You Can Believe In

1. Evidence Based InterventionChange You Can Believe In Dr Paul Montgomery Reader in Psycho-Social Intervention University of Oxford

2. Acknowledgements • Colleagues at The Centre for Evidence-Based Intervention: Gretchen Bjornstad, Raeli Bronstein, Frances Gardner, Evan Mayo-Wilson, Don Operario, Alex Richardson, Victor Spoormaker, Kristen Underhill. • The Cochrane Collaboration • Oxford University: Student Counselling Service, Dept of Psychiatry, Dept of Public Health, Centre for Statistics in Medicine • Funders: NHS SE R&D £250K; NHS (Health Technology Assessment) £410k; Martek Biosciences £647k; John Fell Fund £98k & £37k; Swedish Board of Health and Welfare £150k; Danish Board of Social Research £90k. Dept of Health £102k. • Many participants, patients and clients who have taken part in these projects.

3. Change You Can Believe In! • What is Evidence-Based Practice? • Look at 4 projects • Brief treatments for anxiety • Omega-3s for behaviour and learning in children • Sleep problems in children • Abstinence for HIV prevention in adolescents • Evidence-based practice and policy change • Future work

4. Evidence-Based Practice • Decisions about health and social care are based on the best available, current, valid and relevant evidence. • Decisions should be made by those receiving care, informed by the tacit and explicit knowledge of those providing care, within the context of available resources. (Martin Dawes, et al. 2005)

5. From Research Questions to EBP

6. The Hierarchy of Evidence Meta-Analysis of Randomised Trials Randomised Trials Non-randomised studies Cohort studies Case-Control studies Non-comparative studies Case Series (open trial) Case reports Expert opinion Internally Valid Evidence of Effectiveness Illustrative examples, hypothesis generating studies

7. The Hierarchy of Evidence Self-Help for Anxiety, Abstinence Education Reviews Fish Oil for Learning and Behaviour Trials Nature and Prevalence of Narcolepsy in Children Cross-sectional Uptake and Compliance with Self-Help Qualitative

8. Self-Help for Anxiety

9. The Problem • Cognitive Behavioural Therapy is the most effective treatment for common mental health problems • Many patients prefer talking therapy to drug therapy • Barriers include • Lack of therapists • High cost/ Long waiting list • Large unmet need

10. Background One Review (Scogin et al. ) found that 1) Self-help is more effective than traditional therapies (A>B) 2) The addition of minimal contact makes self-help more effective (C>A) 3) Traditional therapies are more effective than self-help with minimal contact (B>C) < A C > > B

11. Research Programme C) Large Randomised Trial (in preparation) A) Meta-Analysis of 47 RCTs Systematic Reviews B) Focus Group Study Randomised Trials Non Randomised Studies Case reports, qualitative, expert opinion

12. Results • Meta-Analysis • Mostly positive • Low compliance with treatment • High study dropout • Focus group • Organise by main problems (sleep, work, relationships) • Delivery • Booklets rather than websites • Recommendation by authority figure • Fit (e.g. specificity of vignettes)

13. Next Stage • Large Randomised Controlled Trial • In Primary Care • In Students • MRC have indicated a willingness to fund now that these earlier stages have been done.

14. Fatty Acids and Children

15. The Problem • Fatty acids make up around 20% of dry brain mass • They are required for brain growth and connectivity • Children require five times as much HUFA as they currently consume • Children experience problems in cognitive development, behaviour, and physical function (e.g. vision)

16. Background • Small studies and trials with adults suggest benefits of fatty acid supplements • Blood evidence for deficiencies of Omega-3 / Omega-6 • ADHD (Bekaroglu et al. 1986; Mitchell et al. 1987; Stevens et al., 1995, 1996, 2006) • Dyslexia (Baker 1985; Ross et al. 2004; Cyhlarova et al. 2007) • Autism (Bell et al. 2000, 2004; Vancassel et al. 2001)

17. Research Programme A) Review of randomised and other trials B) Large RCTs i. Oxford-Durham Study ii. DOLAB Systematic Reviews Randomised Trials Non Randomised Studies Case reports, qualitative, expert opinion

18. The Oxford-Durham Study • 117 underachieving children aged 5 to 12 years from mainstream schools • All had difficulties in motor coordination (DSM-IV DCD) • 40% were behind expected achievement in reading and spelling • Over 30% scored in the clinical range for ADHD symptoms (>2SD above population means)

19. Reading and Spelling Active treatment • Gains were > 3 x normal rate for reading, > 2 x for spelling Placebo • Gains were 1 x normal rate for reading, < 0.5 x for spelling Group Differences • Reading p < 0.004 • Spelling p < 0.001 Active Placebo (n=55) (n=57)

20. Behaviour Ratings

21. The DOLAB Study DHA Oxford - Learning and Behaviour

22. The DOLAB Study • Mainstream Children 20th Centile for Reading nationally • Randomised to DHA or Placebo • N=360 • Objective and subjective measures • Recruitment starts January 09

23. Abstinence Education

24. Abstinence-ONLY Abstinence is the only way No HIV or STI facts No safe-sex or condom promotion Abstinence-PLUS Abstinence is the best way HIV and STI facts Safe-sex promotion and condom skills The Problem • There are two general methods of sex education for teens • They are both well-funded and politically controversial • There have been no rigorous reviews of their merits

25. Research Two Systematic Reviews Abstinence ONLY Abstinence PLUS Systematic Reviews Randomised Trials Non Randomised Studies Case reports, qualitative, expert opinion

26. Results • Electronic Search: 30 databases, 20,070 articles • Hand-searched conference abstracts, contacted experts in the field, cross-referenced reviews and papers • 13 Abstinence ONLY trials • 15,940 children and adolescents • No biological or behavioural benefits. Some harms. • 39 Abstinence PLUS trials • 37,724 children and adolescents • Some biological benefits, consistent behavioural benefits.

27. Biological Outcomes

28. Results: Behavioural Indicators • In contrast to the Abstinence-ONLY interventions, Abstinence-PLUS programmes consistently: • Reduced the incidence of unprotected vaginal sex • Reduced the frequency of unprotected vaginal, oral and anal sex • Reduced the number of partners • Increased condom use • Improved knowledge of STI prevention

29. Sleep

30. Sleep Problems in Children • Children with learning disabilities • Severe and enduring sleep problems with onset and maintenance of sleep • Leads to family discord • Child abuse • Children with Narcolepsy • Poorer life chances suspected • Weak evidence about the course of the disease • Treatments improving

31. Research Programme C) 2 RCTs for children with LDs i. Booklets ii. Melatonin A) Systematic Review of media-based interventions for behavioural problems in children B) Largest ever cohort of children with narcolepsy and EDS (still tracking) Systematic Reviews Randomised Trials Non Randomised Studies Case reports, qualitative, expert opinion

32. Booklets and Sleep • The most effective treatment for sleep problems is behavioural • Face-to-face treatment is difficult to access • Expensive • Lack of therapists • It may be possible to use self-help to teach parents to help their children

33. Booklets and Sleep • 66 children (2-8) with severe learning impairments • Randomised to therapist, booklet or wait-list • Both active treatments were effective • Reduced sleep onset time and frequency of nights with sleep problems • Gains maintained at 6 month follow-up

34. Melatonin in Children with Neuro-developmental Delay • Rationale • Current unsystematic use of melatonin • Some evidence of positive effects • Need for a multi centre, randomised, placebo-controlled study • Objective • To confirm (or refute) that immediate release melatonin is beneficial compared to placebo in improving total duration of night-time sleep and can reduce sleep latency in children with neuro-developmental problems.

35. Participating Centres Derbyshire Children’s Hospital, Queens Medical Centre, Chesterfield Royal Hospital Royal Manchester Children’s Hospital Royal Liverpool Children’s Hospital Birmingham Children’s Hospital John Radcliffe Hospital St Georges Hospital Bristol Royal Hospital for Sick Children Evelina Children’s Hospital, Great Ormond Street Hospital, University College Hospital London

36. Melatonin in Children with Neuro-developmental Delay • Trial underway. • All participants begin with a booklet • Randomised, dose-ranging assignment to melatonin or placebo • Outcomes expected 2010.

37. Narcolepsy/Excessive Daytime Sleepiness in Children • Largest cohort of Narcoleptic and EDS children ever assembled. 50% from the UK 50% from the US and RoW • No sig diffs on age gender or SEG • Variables- behaviour, mood, educational attendance, difficulties,

38. Narcolepsy in Children • Chronic disorder of hypocretin system leading to REM sleep intrusions into wakefulness. • 4 main components: • Sleep attacks • Hypnogogic hallucinations • Sleep paralysis • Cataplexy

39. Cataplexy Movie

40. Narcolepsy/EDS/Controls

41. Methodological Work

42. Methodological Work • Reporting guidelines for RCTs and Systematic Reviews • The Oxford Implementation Index • Trial Design • Delivery by Practitioners • Uptake by Participants • Context

43. EBP and Policy Change • European Union Consultative Committees • Parliamentary Food and Health Forum • Federal Funding for Abstinence Only Programmes Withdrawn • NHS adopts behavioural sleep programmes for kids as frontline treatment- then booklets based one.

44. Impact

45. Future Directions Online Cognitive Behavioural Intervention for Insomnia Reviews Positive youth development programmes for at risk adolescents Trials Unaccompanied asylum seeking children Cross-sectional Sanitary protection for girls in Ghana Qualitative

46. Questions

47. References Montgomery P, Richardson AJ. Omega-3 fatty acids for bipolar disorder. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD005169. DOI: 10.1002/14651858.CD005169.pub2 Mayo-Wilson, E. and Montgomery, P., (2007). Media-delivered cognitive behavioural therapy and behavioural therapy (self-help) for anxiety disorders in adults.(Protocol) Cochrane Database of Systematic Reviews, Issue 1. Art. No.:CD005330. DOI: 10.1002/14651858.CD005330.pub3. Underhill, K., Operario, D., and Montgomery, P., (2007) Systematic review of abstinence-plus HIV prevention programs in high-income countries. PLoS Medicine 4(9): e275, doi:210.1371/journal.pmed.0040275. Underhill, K., Operario, D., and Montgomery, P., (2007) Sexual abstinence only programmes to prevent HIV infection in high income countries: Systematic review. British Medical Journal; 335(7613):248. Underhill, K., Operario, D., and Montgomery, P., (2007) Reporting deficiencies in trials of abstinence-only programmes for HIV prevention. AIDS;21(2):266-268. Underhill, K., Montgomery, P. and Operario, D., (2007) Abstinence-based programs for HIV infection prevention in high-income countries [Protocol]. The Cochrane Database of Systematic Reviews; 2005: Issue 3, Art. No.:CD005421. doi: 005410.001002/14651858.CD14005421. Stores, G., Montgomery, P., and Wiggs, L., (2006) The Psychosocial Problems of Children with Narcolepsy and Those With Excessive Daytime Sleepiness of Uncertain Origin Pediatrics 118; 1116-1123 Montgomery, P., Bjornstad, G., and Dennis, J., (2006) Media-based behavioural treatments for behavioural problems in children. The Cochrane Database of Systematic Reviews, Issue 1. Art. No.: CD002206. DOI: 10.1002/14651858.CD002206.pub3. Richardson, A.J. and Montgomery, P., (2005) The Oxford-Durham Study: A Randomized Controlled Trial of Dietary Supplementation with Fatty Acids in Children with Developmental Coordination Disorder. Pediatrics 115(5): pp 1360-1366 Montgomery, P., Stores, G., and Wiggs, L.D., (2004) The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial. Archives of Disease in Childhood. 89, 125-130. Stores, G., Montgomery, P. and Wiggs, L., (2004) Psychosocial Problems In Childhood Narcolepsy Journal of Sleep Research Vol 13, p689. Wiggs, L., Montgomery, P. and Stores, G (2004) Parent Report And Actigraphy: Sleep Patterns In Children With Attention Deficit Hyperactivity Disorder. Journal of Sleep Research Vol 13, p799. Montgomery, P. and Cook, C. (2001) Perspectives on parent education: in Warren-Adamson, C. (Ed.) Family Centres and their part in Social Action. London: Ashgate. Montgomery, P and Dunne, D. (2006) Treatment of sleep problems in children. Clinical Evidence. BMJ Books. London.

48. Evidence Based InterventionChange You Can Believe In Dr Paul Montgomery Reader in Psycho-Social Intervention University of Oxford