Exclusion, refusal rates moderate in youth suicide prevention RCTs

Researchers found moderate rates of exclusion and refusal in youth suicide prevention randomized controlled trials, according to results of a meta-analysis published in Journal of Clinical Psychiatry.

“To the best of our knowledge, a systematic evaluation has yet to examine the extent to which study participants are ineligible for or unwilling to participate in RCTs examining youth suicide–related outcomes,” Ryoko Susukida, PhD, of the department of mental health at Johns Hopkins Bloomberg School of Public Health, and colleagues wrote.

“Human subject research on suicide prevention among youth is associated with a number of ethical and practical concerns including adverse events, liability and patient safety, which may result in a more restrictive set of exclusion criteria,” they said. “Furthermore, while an increasing number of studies have demonstrated that asking questions about suicide does not have iatrogenic effects on youth, parents and youth may refuse participation in RCTs of suicide prevention interventions due to the perception that they may induce psychological distress.”

Susukida and colleagues analyzed exclusion and refusal rates in 36 RCTs that examined suicide-related outcomes in the U.S. among individuals aged 25 years or younger. They searched six databases between January 1990 and May 2020 for the terms “suicide prevention” and “clinical trial.” The 13,264 study participants had a mean age of 14.87 years, and 50% were male, 23% African American and 24% Hispanic.

Results showed an exclusion rate of 36.4% and a refusal rate of 25.5%. Studies that excluded individuals who did not exceed specified cutoff points of suicide screening tools (51.2%) and those who did not meet the age or school grade criterion (45.9%) had significantly higher exclusion rates.

“The results of this study suggest that the rates of exclusion and refusal in youth suicide prevention RCTs and other RCTs studying suicide outcomes in the U.S. were moderate,” Susukida and colleagues wrote. “While there was strong sociodemographic and racial/ethnic group representation in youth suicide prevention RCTs in the U.S., the specific exclusion criteria of many studies limited the range of suicide risk and comorbid conditions. The quality of future RCTs of youth suicide prevention interventions could be improved by better reporting and more awareness of sample representativeness and generalizability.”