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Stepped Care for Children After Trauma: Optimizing Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537678
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Stepped Care TF-CBT Behavioral: Standard TF-CBT Not Applicable

Detailed Description:

Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to "Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness," and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in "real world" settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed:

Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment);

Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT;

Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment;

Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stepped Care for Children After Trauma: Optimizing Treatment
Actual Study Start Date : August 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stepped Care TF-CBT
Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT.
Behavioral: Stepped Care TF-CBT
Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks

Active Comparator: Standard TF-CBT
Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT.
Behavioral: Standard TF-CBT
Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).




Primary Outcome Measures :
  1. Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms [ Time Frame: Change from baseline in posttraumatic stress symptoms at post treatment and 6 and 12 months ]
    Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child PTSD symptoms for children ages 4-12

  2. Child Sheehan Disability Scale (CSDS) Parent version [ Time Frame: Change from baseline impairment at post treatment and 6 and 12 months ]
    The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the SCDS-Parent version will be used to measure change in impairment.


Secondary Outcome Measures :
  1. Child Behavior Checklist Internalizing symptoms [ Time Frame: Change from baseline in internalizing symptoms at post treatment and 6 and 12 months ]
    Changes in T scores in internalizing symptoms

  2. Child Behavior Checklist Externalizing symptoms [ Time Frame: Change from baseline in externalizing symptoms at post treatment and 6 and 12 months ]
    Changes in T scores in externalizing symptoms

  3. Clinical Global Impression-Severity (CGI-S) [ Time Frame: Change from baseline in severity at post treatment and 6 and 12 months ]
    The CGI-S is a widely used 7-point rating of severity of psychopathology including impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.

  4. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Participants will be assessed for treatment improvement at post treatment and 6 and 12 months ]
    The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.


Other Outcome Measures:
  1. Parenting Stress Scale (PSS) [ Time Frame: Change from baseline in parenting stress at post treatment and 6 and 12 months ]
    The PSS scores will be used to measure change in parenting stress

  2. Depression, Anxiety and Stress Scale (short form), DASS [ Time Frame: Change from baseline in parent depression at post treatment and 6 and 12 months ]
    DAS self-report will be used to measure change in parent depression

  3. The PTSD Checklist-Civilian (PCL-C) [ Time Frame: Change from baseline in parent depression at post treatment and 6 and 12 months ]
    The PCL-C will be used to measure change in parent self-report of PTSD symptom severity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Child experienced at least one traumatic event after the age of 36 months
  2. Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance
  3. At enrollment, the child must be between 4-12 years of age
  4. The parent/guardian must be willing and able to participate in the treatment and complete informed consent

Exclusion Criteria:

  1. Psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions
  2. Parent has had substance use disorder (SUD) within the past 3 months.
  3. Child or parent is suicidal
  4. Child or parent is not fluent in English
  5. Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
  6. Child is receiving trauma-focused psychotherapy during study treatment.
  7. Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home
  8. Child is having unsupervised face-to-face contact with the identified perpetrator
  9. Siblings

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537678


Locations
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United States, Florida
Children's Home Society
Jacksonville, Florida, United States, 32207
Directions for Living
Largo, Florida, United States, 33773
USF St. Petersburg Family Study Center
Saint Petersburg, Florida, United States, 33701
Crisis Center of Tampa Bay
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Alison A Salloum, PhD University of South Florida
Publications of Results:
Other Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02537678    
Other Study ID Numbers: 1R01MH107522-01 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data dictionaries for the descriptive and analyzed data were uploaded for the NIMH Data Archive (Salloum C2318).
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders