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

ConditionsTrauma ExposureTraumaTrauma and Stressor Related DisorderMental Health FunctioningChronic Medical ConditionsChronic Medical ConditionChronic Medical IllnessPosttraumatic Stress Disorder PTSDPosttraumatic Stress DisordersPosttraumatic Stress SymptomsPosttraumatic Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorAnthony Vesco

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: SPARCS Group Therapy [Stage 1 Randomization]Experimental treatment 1 intervention
Group B: Unified Protocol Group Therapy [Stage 1 Randomization]Experimental treatment 1 intervention
Group C: SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization]Experimental treatment 1 intervention
Group D: UP Individual Therapy for Non-Responders [Stage 2 Randomization]Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
2

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
3

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
4

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.

Secondary outcomes

1

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
2

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.

Time frame
Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anthony Vesco

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Northwestern University

Collaborator

Source ClinicalTrials.gov
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