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Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress

NCT07483333 · Ann & Robert H Lurie Children's Hospital of Chicago
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Official title
Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition
About this study
The Supporting Purposeful Interventions \& Resilience in Trauma (SPIRIT) program at Ann \& Robert H. Lurie Children's Hospital of Chicago provides trauma-informed, evidence-based care for youth ages 8-18 with chronic medical conditions and psychological trauma exposure who are experiencing trauma-related distress. Youth with chronic medical conditions are at increased risk for psychological stress due to frequent medical procedures, hospitalizations, and disease-related challenges, alongside prior family or community adversity. The SPIRIT program integrates behavioral health services into routine clinical care, using structured interventions to address trauma, improve coping, and support daily functioning. This clinical trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to evaluate two cognitive-behavioral therapies: Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP). The SMART design allows researchers to compare the effectiveness of each therapy delivered in isolation and in sequence, providing data on which approach or combination of approaches is most effective for youth who respond differently to initial group treatment. Participants first complete screening and baseline assessments within the SPIRIT program, which includes standardized measures of trauma-related symptoms, emotional distress, and daily functioning. Youth are then randomly assigned to receive group therapy using either SPARCS or UP. Group therapy sessions are delivered in alignment with routine clinical procedures and follow manualized protocols specific to each intervention. Youth who do not demonstrate sufficient improvement after group therapy are re-randomized to receive additional individual therapy using either SPARCS or UP. This stepwise approach allows the study to evaluate the effectiveness of both therapies in isolation, as well as the optimal sequence of group followed by individual therapy. Data collection is embedded within clinical care and occurs at multiple time points: enrollment/baseline, and every 12 weeks through 48 weeks. All participants are followed for up to 48 weeks to evaluate longitudinal changes in trauma symptoms, emotional well-being, and daily functioning. Data collection includes structured surveys, clinician ratings, and retrospective chart review conducted as part of program evaluation. The SPIRIT SMART trial also allows for exploratory analyses of factors that may moderate treatment response, such as individual characteristics, medical complexity, and baseline symptom profiles. Findings from this study will provide valuable guidance for optimizing trauma-focused interventions within pediatric medical settings and support broader dissemination of effective practices for youth facing both medical and psychological challenges.
Eligibility criteria
Inclusion Criteria: * Youth (aged 8-18 years) who received a SPIRIT program psychological trauma screening and were deemed clinically appropriate for SPIRIT group therapy. Clinically appropriate means the youth can historically engage in a group setting (e.g., school, camp, therapy group) without significant disruption to the group process or other participants. * Youth and parent/legal guardian are willing and able to provide informed consent/assent for randomization. * Youth and parent/legal guardian are fluent in English or Spanish. * Youth is not currently engaged in individual therapy at the time of enrollment (per patient/parent report). Exclusion Criteria: * Wards of the state or DCFS youth in care. * Youth with reported or observed symptoms that would significantly impair group therapy engagement, including but not limited to: intellectual disability, moderate-to-severe autism spectrum disorder, active suicidal ideation, uncontrolled psychosis, or other acute psychiatric symptoms that could disrupt the group process. * Regular use of alcohol or other substances that interfere with participation or disrupt the group process. * Youth requiring immediate higher-level psychiatric care (e.g., intensive outpatient programming, partial hospitalization, inpatient psychiatric admission, or residential treatment) at the time of first randomization.
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2026-10
Estimated completion: 2029-09-29
Last updated: 2026-09-15
Interventions
Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - GroupBehavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - GroupBehavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - IndividualBehavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual
Primary outcomes
  • Pediatric Traumatic Stress Screening Tool (Caregiver Report) (Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.)
  • Pediatric Traumatic Stress Screening Tool (Youth Self-Report) (Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.)
  • Revised Children's Anxiety and Depression Scale - 25 (Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.)
Sponsor
Anthony Vesco · other
With: Substance Abuse and Mental Health Services Administration (SAMHSA), Northwestern University
Contacts & investigators
ContactAnthony T. Vesco, PhD · contact · avesco@luriechildrens.org · 312-227-5075
All locations (1)
Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
Chicago, Illinois, United States