Recruiting

SPARCS & UP

Sponsor:

Anthony Vesco

Code:

NCT07483333

Conditions

Trauma Exposure

Trauma

Trauma and Stressor Related Disorder

Mental Health Functioning

Chronic Medical Conditions

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual

Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual

Study Details

Brief summary:

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

Study ID

NCT07483333

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Sep 29, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

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.

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. ]
  • Pediatric Traumatic Stress Screening Tool (Youth Self-Report) [ Time Frame: 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 [ Time Frame: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline. ]
  • The Revised Children's Anxiety and Depression Scale - 25, Parent [ Time Frame: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline. ]
  • Ohio Scales for Youth Functioning Scale (Caregiver Report) [ Time Frame: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline. ]
  • Ohio Scales for Youth Functioning Scale (Youth Self-Report) [ Time Frame: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline. ]

Central Contacts and Locations

Central contacts

Anthony T. Vesco, PhD

312-227-5075avesco@luriechildrens.org

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Anthony T. Vesco, PhD

312-227-5075avesco@luriechildrens.org

More Information

Sponsor

Anthony Vesco

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • pediatric trauma
  • posttraumatic stress disorder
  • chronic medical conditions
  • pediatrics
  • trauma symptoms
  • trauma and stressor related disorder
  • trauma informed care
  • Sequential, Multiple Assignment Randomized Trial
  • Supporting Purposeful Interventions and Resilience in Trauma
  • Unified Protocol
  • Structured Psychotherapy for Adolescents Responding to Chronic Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Anthony Vesco on 2026-09-15.