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

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Conditions studied: Trauma Exposure, Trauma, Trauma and Stressor Related Disorder, Mental Health Functioning, Chronic Medical Conditions, Chronic Medical Condition, Chronic Medical Illness, Posttraumatic Stress Disorder PTSD, Posttraumatic Stress Disorders, Posttraumatic Stress Symptoms, Posttraumatic Stress

In brief

The goal of this clinical trial is to compare the effectiveness of trauma-focused therapies for improving mental health symptoms and daily functioning in youth with chronic medical conditions who have experienced psychological trauma and trauma-related distress. The study evaluates two evidence-based cognitive-behavioral therapies - Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP) - delivered in group and individual formats to determine which approach, or combination of approaches, best reduces trauma symptoms and supports coping and adjustment. The study will also help researchers understand how to best support youth who continue to experience distress after an initial round of therapy. The main questions it aims to answer are: * Does SPARCS group therapy or UP group therapy lead to greater improvements in trauma symptoms and functional impairment? * For youth who do not show enough improvement after group therapy, does adding SPARCS or UP individual therapy lead to better outcomes? * Which sequence of group and individual therapies leads to the greatest improvements in trauma symptoms and functioning? Researchers will compare two evidence-based therapies currently offered at Ann \& Robert H. Lurie Children's Hospital of Chicago. Youth will first be randomly assigned to receive either SPARCS or UP in a group format. After completing group therapy, youth who still need additional support will be randomly assigned again to receive individual or family therapy using SPARCS or UP. This stepwise approach will help identify which sequence of therapies leads to the best overall outcomes for youth. Participants will: * Take part in group therapy sessions using either SPARCS or UP * For those needing additional support after group therapy, participate in individual SPARCS or UP therapy * Complete brief assessments of mental health and daily functioning at enrollment, and every 12 weeks thereafter for 48 weeks, as part of their regular care through Ann \& Robert H. Lurie Children's Supporting Purposeful Interventions \& Resilience in Trauma (SPIRIT) program

Key facts

Study ID

NCT07483333

Run by

Anthony Vesco

People needed

400

Starts

2026-07-01

Expected to finish

2029-09-29

Last updated by the study team

2026-03-19

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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