Psychotherapy for Trauma-Related Distress
What You Need to Know Before You Apply
What is the purpose of 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
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Group Therapy
Participants receive either SPARCS or UP group therapy sessions
Individual Therapy
Participants who do not show sufficient improvement after group therapy receive additional individual therapy using either SPARCS or UP
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Structured Psychotherapy for Adolescents Responding to Chronic Stress
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
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).
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.
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anthony Vesco
Lead Sponsor
Substance Abuse and Mental Health Services Administration (SAMHSA)
Collaborator
Northwestern University Feinberg School of Medicine
Collaborator
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