Clinical trial NCT02537678: Stepped Care for Children After Trauma: Optimizing Treatment
Official title: Stepped Care for Children After Trauma: Optimizing Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 183
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Parent/Guardian-child dyads enrolled.

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

Primary outcomes:
measure: Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
timeFrame: Post treatment
measure: Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
timeFrame: 6-month Follow up
measure: Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
timeFrame: 12-month follow up
measure: Child Sheehan Disability Scale Parent Version
timeFrame: Post treatment
measure: Child Sheehan Disability Scale Parent Version
timeFrame: 6-month follow up
measure: Child Sheehan Disability Scale Parent Version
timeFrame: 12-month follow up
Secondary outcomes:
measure: Child Behavior Checklist Internalizing Symptoms
timeFrame: Post treatment
measure: Child Behavior Checklist Internalizing Symptoms
timeFrame: 6-month follow up
measure: Child Behavior Checklist Internalizing Symptoms
timeFrame: 12-month follow up
measure: Child Behavior Checklist Externalizing Symptoms
timeFrame: Post treatment
measure: Child Behavior Checklist Externalizing Symptoms
timeFrame: 6-month follow up
measure: Child Behavior Checklist Externalizing Symptoms
timeFrame: 12-month follow up
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: Post treatment
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 6-month assessment
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 12-month follow up
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: Post treatment
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 6-month treatment
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 12-month follow up
Other outcomes:
measure: Parenting Stress Scale (PSS)
timeFrame: Post treatment
measure: Parenting Stress Scale (PSS)
timeFrame: 6-month follow up
measure: Parenting Stress Scale (PSS)
timeFrame: 12-month follow up
measure: Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
timeFrame: Post treatment
measure: Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
timeFrame: 6-month follow up
measure: Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
timeFrame: 12-month follow up
measure: The PTSD Checklist-Civilian (PCL-C)
timeFrame: Post treatment
measure: The PTSD Checklist-Civilian (PCL-C)
timeFrame: 6-month follow up
measure: The PTSD Checklist-Civilian (PCL-C)
timeFrame: 12-month follow up
Locations:
city: Jacksonville
country: United States
facility: Children's Home Society
state: Florida
city: Largo
country: United States
facility: Directions for Living
state: Florida
city: New Port Richey
country: United States
facility: Pasco Kids First
state: Florida
city: Saint Petersburg
country: United States
facility: USF St. Petersburg Family Study Center
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Center, Inc
state: Florida
city: Tampa
country: United States
facility: Crisis Center of Tampa Bay
state: Florida
Study officials:
affiliation: University of South Florida
name: Alison A Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.
citation: Salloum A, Scheeringa MS, Cohen JA, Storch EA. Responder Status Criterion for Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children. Child Youth Care Forum. 2015 Feb;44(1):59-78. doi: 10.1007/s10566-014-9270-1.
citation: Salloum A, Robst J, Scheeringa MS, Cohen JA, Wang W, Murphy TK, Tolin DF, Storch EA. Step one within stepped care trauma-focused cognitive behavioral therapy for young children: a pilot study. Child Psychiatry Hum Dev. 2014 Feb;45(1):65-77. doi: 10.1007/s10578-013-0378-6.
citation: Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.