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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: * 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
Details
| Lead sponsor | Anthony Vesco |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 400 |
| Start date | 2026-07 |
| Completion | 2029-09-29 |
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
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
Primary outcomes
- Pediatric Traumatic Stress Screening Tool (Caregiver Report) — Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
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. - Pediatric Traumatic Stress Screening Tool (Youth Self-Report) — Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
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. - Revised Children's Anxiety and Depression Scale - 25 — 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 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. - The Revised Children's Anxiety and Depression Scale - 25, Parent — 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 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. - Ohio Scales for Youth Functioning Scale (Caregiver Report) — Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
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. - Ohio Scales for Youth Functioning Scale (Youth Self-Report) — Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.
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.
Countries
United States