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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group — BEHAVIORAL
  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.
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group — BEHAVIORAL
  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.
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual — BEHAVIORAL
  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.
• Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual — BEHAVIORAL
  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.

Study Details

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 Dates

Start date

Jul 31, 2026

Status verified

Mar 2026

Primary completion

Sep 30, 2029

Completion

Sep 29, 2029

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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).
• 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).
• 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.
• 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.

Primary Outcome Measure

Pediatric Traumatic Stress Screening Tool (Caregiver Report) [ Time Frame: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline. ]

Central Contacts

• Anthony T. Vesco, PhD
  312-227-5075
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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