Anxiety & Depression Association of America

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

Purpose

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

Conditions

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

Eligibility

Eligible Ages: Between 8 Years and 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential multiple assignment randomized trial (SMART)
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental SPARCS Group Therapy [Stage 1 Randomization]	Participants are initially randomized to receive Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) in a group format. Participants who do not show sufficient improvement after Stage 1 will be re-randomized to Stage 2 individual therapy (SPARCS or Unified Protocol).	Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group SPARCS is a manualized, cognitive-behavioral group program for youth (12-21 years) exposed to chronic interpersonal trauma or multiple trauma types, including community and domestic violence. The program is strength-based and present-focused, with adolescent-tailored content targeting affect regulation, impulsivity, self-perception, relationships, somatic symptoms, dissociation, avoidance, and challenges with personal purpose or worldview. SPARCS supports emotional, social, academic, and behavioral functioning and is appropriate for youth with or without PTSD experiencing ongoing trauma-related stress. Group sessions are delivered over 12-16 weekly, in-person sessions by licensed mental health providers. Other names: SPARCS
Experimental Unified Protocol Group Therapy [Stage 1 Randomization]	Participants are initially randomized to receive Unified Protocol (UP) in a group format. Participants who do not show sufficient improvement after Stage 1 will be re-randomized to Stage 2 individual therapy (SPARCS or UP).	Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP) is a manualized, transdiagnostic cognitive-behavioral intervention for youth with emotional disorders, including trauma-related distress. UP targets underlying emotion regulation processes across anxiety, depression, and related symptoms. Group sessions teach participants to identify, understand, and modify maladaptive emotional responses while promoting adaptive coping. Core components include mindful emotional awareness, cognitive flexibility, exposure to avoided emotions, and behavioral activation. UP has been shown effective for youth with trauma-related distress and youth with chronic medical conditions. Group sessions are delivered over 12-16 weekly, in-person sessions by licensed mental health providers. Other names: UP Unified Protocol
Experimental SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization]	Participants who do not show sufficient improvement after Stage 1 group therapy and are re-randomized to individual therapy receive Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) individual therapy. Sessions are tailored to participant needs and may include family involvement. Treatment duration is guided by participant response, with booster sessions as needed.	Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual SPARCS Individual is a manualized, skills-based cognitive-behavioral intervention for youth (12-21 years) exposed to chronic interpersonal trauma or multiple trauma types. Individual sessions are tailored to each participant's clinical needs, targeting affect regulation, impulsivity, self-perception, relationships, somatic symptoms, dissociation, avoidance, and challenges with personal purpose or worldview. Individual therapy may involve family participation and supports emotional, social, academic, and behavioral functioning. Sessions are typically held weekly, with duration guided by participant response and maintenance or booster sessions provided as needed. Other names: SPARCS
Experimental UP Individual Therapy for Non-Responders [Stage 2 Randomization]	Participants who do not show sufficient improvement after Stage 1 group therapy and are re-randomized to individual therapy receive Unified Protocol individual therapy. Sessions are tailored to participant needs. Treatment duration is guided by participant response, with booster sessions as needed.	Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP) is a manualized, transdiagnostic cognitive-behavioral intervention for youth with emotional disorders, including trauma-related distress. UP can be delivered in group or individual formats and targets underlying emotion regulation processes across anxiety, depression, and related symptoms. Sessions teach participants to identify, understand, and modify maladaptive emotional responses while promoting adaptive coping. Core components include mindful emotional awareness, cognitive flexibility, exposure to avoided emotions, and behavioral activation. UP has been shown to be effective for youth with trauma-related distress and youth with chronic medical conditions. Sessions are typically held weekly, with duration guided by participant response and maintenance or booster sessions provided as needed.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Anthony Vesco

Study Contact

Anthony T. Vesco, PhD
312-227-5075
avesco@luriechildrens.org

Detailed Description

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.