Trauma ExposureNCT07483333
Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress
A study testing Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group, Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group and Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual in people with Trauma Exposure and Trauma, run by Anthony Vesco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Trauma Exposure, Trauma, Trauma and Stressor Related Disorder
- What is being tested?
- Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group, Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group and Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 29 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Anthony T. Vesco, PhD, 312-227-5075, avesco@luriechildrens.org
About this study
Official title: Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition
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:
Read more
- 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
Read the 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.
- Conditions
- Trauma Exposure, Trauma, Trauma and Stressor Related Disorder, Mental Health Functioning, Chronic Medical Conditions, Chronic Medical Condition
- Being tested
- 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
- 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
- Medical subject headings
- Wounds and Injuries, Trauma and Stressor Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Psychotherapy for Adolescents Responding to Chronic Stress - GroupBehavioural
Also called SPARCS
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 - GroupBehavioural
Also called UP, Unified Protocol
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 - IndividualBehavioural
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 - IndividualBehavioural
Also called SPARCS
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 group | Role | What they receive |
|---|---|---|
| SPARCS Group Therapy [Stage 1 Randomization] | Experimental | 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). Receives: Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group |
| Unified Protocol Group Therapy [Stage 1 Randomization] | Experimental | 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). Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group |
| SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization] | Experimental | 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. Receives: Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual |
| UP Individual Therapy for Non-Responders [Stage 2 Randomization] | Experimental | 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. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Traumatic Stress Screening Tool (Caregiver Report)
A 12-item caregiver-report measure assessing youth posttraumatic stress symptoms related to any endorsed psychological trauma exposure. Designed to assist clinicians in evaluating and diagnosing posttraumatic stress disorder (PTSD). Caregiver respondents rate the frequency of traumatic stress symptoms in their child over the past month (e.g., "When something reminds my child of what happened, he/she has strong feelings in his/her body, like his/her heart beats fast, headaches or stomach aches") using a 5-point Likert scale. Items are summed to calculate a sum score, ranging from 0 to 48, with higher scores indicating higher levels of traumatic stress symptoms, and scores of 21 or greater indicate clinically elevated ("probable PTSD") traumatic stress symptoms.
Measured: 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)
A 12-item self-report measure assessing posttraumatic stress symptoms related to any endorsed psychological trauma exposure. Designed to assist clinicians in evaluating and diagnosing posttraumatic stress disorder (PTSD). Youth respondents rate the frequency of traumatic stress symptoms they have experienced over the past month (e.g., "When something reminds me of what happened, I have strong feelings in my body, like my heart beats fast, headaches or stomach aches") using a 5-point Likert scale. Items are summed to calculate a sum score, ranging from 0 to 48, with higher scores indicating higher levels of traumatic stress symptoms, and scores of 21 or greater indicate clinically elevated ("probable PTSD") traumatic stress symptoms.
Measured: 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
The Revised Children's Anxiety and Depression Scale -25 is a 25-item youth self-report measure assessing anxiety and depressive symptoms. Respondents rate the frequency with which they experience symptoms (e.g., "I feel sad or empty) using a 4-point Likert scale. Scores on individual items are summed to calculate depression (10 items; scores range from 0 to 30), anxiety (15 items; scores range from 0 to 45), and overall depression and anxiety (25 items; scores range from 0 to 75) sum scores. Higher scores indicate greater levels of depression and anxiety symptoms. Raw scores can be converted to t-scores using normed data based on child biological sex and age.
Measured: 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
The Revised Children's Anxiety and Depression Scale - 25, Parent is a 25-item measure assessing caregiver report of youth anxiety and depressive symptoms. Respondents rate the frequency with which their child experiences symptoms (e.g., "My child feels sad or empty) using a 4-point Likert scale. Scores on individual items are summed to calculate depression (10 items; scores range from 0 to 30), anxiety (15 items; scores range from 0 to 45), and overall depression and anxiety (25 items; scores range from 0 to 75) sum scores. Higher scores indicate greater levels of depression and anxiety symptoms. Raw scores can be converted to t-scores using normed data based on child biological sex and age.
Measured: 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)
The Ohio Scales for Youth Functioning Scale (Caregiver Report) is a 20-item measure assessing caregiver report of youth functional impairment across settings and daily living. Respondents rate the degree of functional impairment children experience across everyday activities (e.g., "Controlling emotions and staying out of trouble"; "Getting along with friends") using a 5-point Likert scale. Scores on individual items are summed to calculate an overall functional impairment score, ranging from 0 to 100, in which lower scores indicate greater functional impairment in everyday activities. Scores at or below 50 are considered clinically elevated functional impairment.
Measured: 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)
The Ohio Scales for Youth Functioning Scale (Youth Self-Report) is a 20-item measure assessing self-report of youth functional impairment across settings and daily living. Respondents rate the degree of functional impairment they experience across everyday activities (e.g., "Controlling emotions and staying out of trouble"; "Getting along with friends") using a 5-point Likert scale. Scores on individual items are summed to calculate an overall functional impairment score, ranging from 0 to 100, in which lower scores indicate greater functional impairment in everyday activities. Scores at or below 60 are considered clinically elevated functional impairment.
Measured: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
Secondary outcomes (2)
Multidimensional Scale of Perceived Social Support (Youth Self-Report)
The Multidimensional Scale of Perceived Social Support is a 12-item self-report measure assessing perceived social support from friends, family, and significant others. Respondents rate the degree to which they agree with each statement (e.g., "My family really tries to help me") using a 7-point Likert scale. Mean scores are calculated across three subscales: friend support (4 items; scores range from 1 to 7), family support (4 items; scores range from 1 to 7), and significant other support (4 items; scores range from 1 to 7). An overall social support score is calculated by averaging responses across all 12 items (scores range from 1 to 7). Across all subscale and total scores, higher values indicate higher levels of perceived social support.
Measured: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
Distress Tolerance Scale Youth Self-Report
The Distress Tolerance Scale is a 15-item self-report measure assessing individuals' ability to tolerate uncomfortable emotional states, physical sensations, and emotion-related behavioral urges. Respondents rate the extent to which they agree with each statement (e.g., "Feeling upset or distressed is unbearable to me") using a 5-point Likert scale. When used with youth, 12 items are summed to create a total distress tolerance score; 11 of these items are reverse scored, and one item is not. Lower scores indicate greater distress tolerance.
Measured: Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Trauma ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential multiple assignment randomized trial (SMART)
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony Vesco
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), Northwestern University
- Responsible party
- Sponsor-investigator, Anthony Vesco, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483333
- Sponsor's protocol ID
- 2025-7413
- Other IDs
- H79SM087908
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the study results, along with a data dictionary, will be made available upon reasonable request. Requests should be directed to the principal investigator for review. Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the aims of the approved proposal. The study team will review requests with the IRB and other relevant data management collaborators at Lurie Children's to obtain institutional approvals and guarantee legal and ethical research and HIPAA compliance. To gain access, data requestors will need to sign a data access and use agreement.
Publications
Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and emotion, 29(2), 83-102.
Tonarely NA, Ehrenreich-May J. Confirming the Factor Structure and Validity of the Distress Tolerance Scale (DTS) in Youth. Child Psychiatry Hum Dev. 2020 Aug;51(4):514-526. doi: 10.1007/s10578-019-00935-z.
PubMed 31637572Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The multidimensional scale of perceived social support. Journal of personality assessment, 52(1), 30-41.
Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
PubMed 2280326Ogles, B. M., Melendez, G., Davis, D. C., & Lunnen, K. M. (2001). The Ohio scales: Practical outcome assessment. Journal of Child and Family Studies, 10(2), 199-212.
Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.
PubMed 22329531Botchway-Commey E, DPsych CB, Pace C, Ehrenreich-May J, Kennedy SM, Williams J, DPsychClin ZP, DPsychClin AM, Anderson V, Crowe L. A waitlist randomised control trial of the unified protocol for the treatment of emotional disorders in children and adolescents with chronic medical conditions (The UP-CAM Study): protocol paper. BMC Psychol. 2025 Aug 6;13(1):873. doi: 10.1186/s40359-025-03052-w.
PubMed 40770654Lindenbach, D., Anderson, A., Wang, E., Heintz, M., Rowbotham, M., Ehrenreich-May, J., Arnold, P., & Dimitropoulos, G. (2025). Feasibility and acceptability of implementing a transdiagnostic cognitive behavioral therapy for children impacted by trauma within a residential treatment facility. Child & Youth Services, 46(2), 299-324.
Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.
PubMed 27771133Habib, M., Labruna, V., & Newman, J. (2013). Complex histories and complex presentations: Implementation of a manually-guided group treatment for traumatized adolescents. Journal of family violence, 28(7), 717-728.
National Child Traumatic Stress Network. (2025). Structured psychotherapy for adolescents responding to chronic stress (SPARCS). https://www.nctsn.org/sites/default/files/interventions/structured-psychotherapy-for-adolescent-responding-to-chronic-stress-2025.pdf