Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Pediatric Traumatic Stress Screening Tool (Caregiver Report)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group (Behavioral)
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).
干预措施: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group (Behavioral)
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.
干预措施: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual (Behavioral)
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.
干预措施: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual (Behavioral)
结局指标
主要结局
Pediatric Traumatic Stress Screening Tool (Caregiver Report)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Multidimensional Scale of Perceived Social Support (Youth Self-Report)(Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.)
- Distress Tolerance Scale Youth Self-Report(Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.)
研究者
Anthony Vesco
Associate Professor of Psychiatry and Behavioral Sciences (Child and Adolescent Psychiatry)
Ann & Robert H Lurie Children's Hospital of Chicago