Health Trials

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 statusNot yet recruiting
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

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

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators

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