Distress Matters: Results from the PRISM-HCT Randomized Trial for Adolescents and Young Adults (CO101A)

Outcomes 1. Participants will be able to describe the potential impact of resilience-coaching programs for patients at risk for vs currently endorsing active psychological distress.2. Participants will be able to describe the rationale for intention-to-treat analyses in randomized clinical trials, as well as opportunities to generate hypotheses from otherwise "negative" studies. Key Message In a randomized trial testing a brief, resilience-skills building intervention for adolescents and young adults with advanced blood cancers, the program seemed to work better among youth with mild-moderate distress. Promoting resilience may be more successful when people experience (and hope to improve) feelings of stress and distress. Importance As we endeavor to deliver brief psychosocial interventions to improve quality of life among populations at risk, determining who may benefit from which interventions at which times is critical. In this randomized trial, we found that resilience-coaching may work better for youth already experiencing some degree of distress. Objectives Adolescents and Young Adults (AYAs) receiving Hematopoietic Cell Transplantation (HCT) are at high risk of depression. We aimed to determine if the Promoting Resilience in Stress Management (PRISM) intervention mitigated risks of depression during the first 3 months post-transplant. Secondary aims assessed PRISM's impact on anxiety, sense of resilience, hope, and health-related quality of life (HRQOL). Scientific Methods Utilized We conducted this multi-site, parallel, non-blinded randomized trial from Oct/2019-Dec/2022. AYAs were eligible if they were 12-24 years-old, English- or Spanish-speaking, and within 1 month of HCT. They were assigned 1:1 to PRISM or Usual Care (UC). PRISM is a brief, skills-based, intervention taught by lay-coaches and targeting “resilience resources” (stress-management, goal-setting, cognitive-reframing, and meaning-making). Outcomes included AYA-reported depression (HADS-D) anxiety (HADS-A), resilience (CDRISC10), Hope (Hope scale), and HRQOL (PedsQL-cancer). We conducted intention-to-treat analyses using mixed linear regressions; exploratory analyses assessed the role of baseline depression (HADS-D>4). Results Ninety-four AYAs participated. Their mean age was 16.7 years (SD=4.2); they identified as female [n=43 (46%)], Non-Hispanic white [n=56 (60%)], Hispanic [n=22 (23%)], Non-Hispanic Black [n=9 (10%)]; Asian [n=5 (5%)], and “other”/mixed race [2 (2%)]. Of n=50 assigned to PRISM and n=44 to UC, n=22 (44%) and n=21 (48%) reported concurrent depression. Thirty-six (72%) PRISM-AYAs completed all 4 assigned sessions; n=10 (20%) completed 0-1. In intention-to-treat analyses, PRISM did not impact 3-month depression (b=0.04; 95% CI-1.5,1.6), anxiety (b=0.3; -1.1,1.7), resilience (b=1.1; -1.8,3.9), hope (b=2.6; -1.1,6.2), or HRQOL (b=5.2; -0.2,11.0). Stratified analyses suggested PRISM may help AYAs with active depression (Resilience b=3.6; 2.0,9.3; Hope b=5.7; 0.5,11.0; HRQOL b=7.2; -2.2,17.0). Conclusion(s) We observed no measurable impact of resilience-coaching among a cohort of AYAs receiving HCT; secondary analyses suggest the program may be more effective when limited to those with concurrent distress. Impact Successfully promoting resilience may require recognizing and targeting those who most need it most. Keywords Psychosocial support/Pediatrics