Comparing Therapies for Youth with Chronic Illness and Trauma
This study is comparing two types of therapy for young people (ages 8-18) with chronic medical conditions who have experienced trauma and are struggling with related distress. The therapies are called Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP). Both are cognitive-behavioral therapies, meaning they help you understand and change your thoughts and behaviors. We want to see which therapy, given individually or in a group, works best to reduce trauma symptoms and improve daily functioning. Success will be measured by how much your trauma symptoms, anxiety, and depression improve over nearly a year.
- Study design
- This is an interventional study planning to enroll 400 participants. It uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to compare the effectiveness of different therapy approaches.
- What's involved
- You would participate in therapy sessions and complete questionnaires at the start, and then at 12, 24, 36, and 48 weeks after starting therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 48 weeks (nearly one year) after starting therapy to track changes in their symptoms.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 - 25Baseline; 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, ParentBaseline; 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.