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

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Presentation on theme: "Evidence Based Intervention Change You Can Believe In Dr Paul Montgomery Reader in Psycho-Social Intervention University of Oxford."— Presentation transcript:

1 Evidence Based Intervention Change 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  Evide nce-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 Nature, prevalence of social problem Risk, protective factors Intervention Trials: Efficacy Systematic Reviews and Meta-Analyses Intervention Trials : Effectiveness Practice Guidelines Evidence Based Practice: Judicious application of research to individual clients and organisations

6 Internally Valid Evidence of Effectiveness 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 The Hierarchy of Evidence Illustrative examples, hypothesis generating studies

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

8 Self-Help for Anxiety

9  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 The Problem

10 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) Background A B C > < >

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

12  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) Results

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  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) The Problem

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

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 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 Reading and Spelling Active Placebo (n=55) (n=57)

20 Behaviour Ratings

21 The DOLAB Study DHA Oxford - Learning and Behaviour

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

23 Abstinence Education

24 The Problem 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  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 Two Systematic Reviews Abstinence ONLY Abstinence PLUS Research Case reports, qualitative, expert opinion Non Randomised Studies Randomised Trials Systematic Reviews

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 OutcomeBENEFITNO EFFECT HARM ONLY - STIsNone6 (7068)1 (2711) Short- and long- term ONLY - PregnancyNone8 (7869)1 (1548) Long-term PLUS - STIsNone3 (1734)None PLUS - Pregnancy2 (1435) Long-term 6 (2248)None

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

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 Phase 1ResponseNo responseTotal Face to Face Treatment 15520 Booklet15722 All controls024

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

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  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 Sanitary protection for girls in Ghana Positive youth development programmes for at risk adolescents Unaccompanied asylum seeking children Qualitative Cross-sectional Trials Reviews

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 Intervention Change You Can Believe In Dr Paul Montgomery Reader in Psycho-Social Intervention University of Oxford

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