The role of randomized trials in testing interventions for the prevention of youth suicide

1. The role of randomized trials in testing interventions for the prevention of youth suicide C. Hendricks Brown, Peter A. Wyman, Joseph M. Brinales, & Robert D. Gibbons International Review of Psychiatry, Dec 2007;19(6):1-15

2. Introduction • Suicide recognized as a major public health problem • The third leading cause of death among American youths. • 9% of American high school students reporting a suicide attempt • 2.6% of youth attempts are serious enough for medical attention. • Burden of suicide behavior • Death from suicide • Suicide attempts are 10-40 times as prevalent as completed suicides. • Deep impact on surviving family and friends, the loss to society due to a young person’s death.

3. Introduction • The prevention of suicide to be a priority for many countries. • The US Healthy People 2010 goals • The reduction of deaths from suicide by 2010 from 10.5-10.8/100 000/year (1998 to 2003) to 4.8/100 000.

4. Epidemiological findings on risk and protective factors for suicide: Targets for youth suicide prevention programmes • Good epidemiologic studies that have tracked suicide rates over time, and identified • Which population are at elevated risk • Which risk and protective factors could be targeted for preventing suicide

5. Targeting populations with elevated risk • Less common in ethnic groups that have strong religious prohibitions against suicide. • Attempts are higher in females, males have much higher suicide mortality in most regions except in rural China. • Ideation and attempts tend to occur more often in those youths whose parents also experienced suicidality • Suicide attempts are far more common among males whose sexual orientation is bisexual/homosexual. • Suicide is more common in rural compared to urban.

6. Modifiable risk factors

7. Prevention strategies addressing availability of factors linked to suicide • Official rates of youth suicide in the USA have nearly tripled since the 1950s through 1998 • Increases in alcohol and substance abuse • Increased availability of firearms • The programmes can potentially lead to a reduction in youth suicide • Reduce sales of alcohol to youths • Reduce access to lethal means

8. Changing prevalence of youth suicide • The youth suicide rates especially for males have been decreasing recently in the USA since the mid 1990s • May be due to the large reduction in drug use • But youth suicide had increased 14% in 2004 • The large drop in pediatric prescriptions following the FDA public health advisory in 2003 and black box warning in 2004

9. Treatment for depression and other mental disorders: Implications for prevention of suicide • Increase treatment for depression • The primary strategy identified in Healthy People 2010 • 1/4 of US adults who are depressed receive treatment in 1997 • Treatments of depression • Antidepressant medication and psychotherapy • Psychosocial as well as non-clinical prevention approaches are essential. • Prescriptions are declining in youths • Lack of acceptability and accessibility to mental health services in many area.

10. The role of randomized field trials to evaluate programmes in community-based programmes for preventing youth suicide • Randomized field trials (RFTs), used to test interventions in realistic community settings. • RFTs often use group-based randomization, for example at the level of classrooms or schools. • Suicide intervention require large sample sizes and/or long follow-up periods to determine whether deaths are significantly reduced by exposure.

11. The role of randomized field trials to evaluate programmes in community-based programmes for preventing youth suicide

12. The role of randomized field trials to evaluate programmes in community-based programmes for preventing youth suicide • Alternatives to lowering the required size or length of the study • To select populations that have higher rates of suicide. • Adolescents in rural US counties (20/100 000) • To replace self-inflicted mortality with a surrogate endpoint of self-reported attempted suicide, medical records of an attempt, or suicidal ideation.

13. Three promising psychosocial prevention strategies amenable to evaluation through randomized trials • Tertiary prevention of suicide in clinic or institutionally identified high-risk youths. • Selective or secondary prevention of suicide in difficult to identify of non-clinic high-risk communities. • Protective, universal strategies for the entire population of youths.

14. Tertiary prevention of suicide in clinic or institutionally identified high-risk youths • Psychosocial prevention would be to lessen suicide risk. • A number of interventions have been tested. • Most low intensity or short programmes, such as CBT only in an inpatient setting are generally ineffective. • Longer, more intense interventions can be effective in reducing suicidal behavious. • The low frequency of these condition in the population demonstrates intervention with these high-risk youths alone will not lead to a large reduction in youth suicide.

15. Tertiary prevention of suicide in clinic or institutionally identified high-risk youths • Provide a specific preventive intervention to youths at elevated risk for suicide. • A randomized trial underway now. • Suicidal youths and families who use crisis hot-lines are providing a means of self identification. • One study on crisis hotlines is now underway

16. Secondary prevention of difficult to identify, high-risk youths • The vast majority of suicidal youths do not come to the attention of the mental health system or their schools. • Uses multi-stage psychiatric screening to identify those youths who are at high risk within the general population. • Gould and colleagues found asking about suicide dose not cause increased distress. • Gatekeeper training to identify high-risk youths • Learning warning signs about suicide • Asking the person if they are thinking of killing themselves

17. Protective strategies for an entire youth population • A school-based randomized trial that just beginning will test the Sources of Strength programme. • Implemented in half of the schools after they receive gatekeeper training, Sources of Strength aims at changing peer norms about youths seeking help. • Successful norm change can help youths recognize that suicidality is not a normal condition that must be endured, nor is suicide a common solution to problems they feel.

18. Protective strategies for an entire youth population • Two other classes of pupulation-based programmes • A randomized trial was conducted to evaluate a programme that helps youths identify signs of depression, and found reduced self-reported suicidal attempts. • The second approach uses prevention to target known risk factors for suicide, such as drug abuse, aggressive behaviour, etc. • One randomized trial has been shown to reduce aggressive behaviour, delinquency and drug abuse, and reduce suicidal ideation and attempts by 50%.

19. Two new approaches to conducting population-based randomized field trials to prevent suicide • Dynamic wait-listed design • Multi-trial follow-up design

20. Dynamic wait-listed randomized design • A randomized trial is now underway to test the QPR gatekeeper training programme in 32 middle and high schools, 2500 staff, and 50 000 students in Georgia. • The school district where this trial began had already decided to train all school staff. • The primary outcome of this trial was referral to school for suicidality. • This design called for random assignment of 16 of the schools to the early training condition and the remaining 16 schools to later training.

21. Dynamic wait-listed randomized design

22. Multi-trial follow-up design • The study differs in two important ways from a typical meta-analysis • New data regarding the nature of death of prevention trial decedents are collected on each trial from a National Death Index search. • The analyses require the use of individual level de-identified data, which is not needed for standard meta-analyses.

23. Multi-trial follow-up design • There are now more than 60 well-designed preventive field trials that have tested preventive intervention. • Together they have involves more than 37 000 children. • None of these specifically target suicide. • Many of the studies have long follow-up periods. • Represent an untapped potential for understanding how malleability of early risk factors can affect suicide

24. Discussion • Progress in understanding what works in suicide prevention has been regrettably very slow. • Randomized trials are a great asset in evaluating prevention programmes. • None of preventive trials has a chance of reducing the population level of suicide below 5%, because the proportion who have these risk factors is very small. • Population-based prevention programmes provide the best opportunities for making dramatic reductions in suicide.

25. Discussion • Two main challenges in conducting randomized trials in suicide prevention research • Require statistical solution • Using a multi-trial follow-up design of the more than 100 000 youths. • A partnership between community leaders and researchers is essential. • Dynamic wait-listed design, better served the training demands in the school district as well. • One important place where large randomized trials may be able to take place is in rural and tribal areas in the USA.

26. Questions • The FDA, in its review and meta-analysis of 24 placebo-controlled trials, concluded antidepressant medication pose 2-fold (4% vs 2%) • Youth suicide has increased 14%

27. Questions • Psychosocial as well as non-clinical prevention approaches are essential. • Prevention approaches conducted in China

28. Strategies reducing suicide rate in China • Tertiary • Psychiatric treatment programme • Provide for psychiatric service • Secondary • Identify high-risk youth • Gatekeeper training • Primary • Reduce sales of alcohol to youths • Reduce access to lethal means, such as pesticide

29. Gatekeeper training programme • Challenge in China • No place to refer • Prevention hardly accepted by individuals themselves or their relatives • Refused to accepted free cognition-behavior therapy in Huairou, Beijing • Confidentiality • Who will keep the psychological files • Independent counseling is suggested • How to identify individuals at high risk of suicide