N/A
Completed N=183
Stepped Care for Children After Trauma: Optimizing Treatment
Source: ClinicalTrials.gov NCT02537678 ↗Enrolled (actual)
183
Serious AEs
13.1%
Results posted
May 2022
Primary outcomePrimary: Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms — 36.00; 35.57 score on a scale — p=.006
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms |
35.05; 34.92 | .001 sig |
| PRIMARY Child Sheehan Disability Scale Parent Version |
7.88; 8.25 | 0.002 sig |
| SECONDARY Child Behavior Checklist Internalizing Symptoms |
45.71; 45.56 | 0.007 sig |
| SECONDARY Child Behavior Checklist Externalizing Symptoms |
46.92; 45.17 | 0.024 sig |
| SECONDARY Clinical Global Impression-Severity (CGI-S) |
1.09; 1.13 | <0.001 sig |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) |
1.74; 1.78 | <0.001 sig |
Eligibility Criteria
Parent/Guardian-child dyads enrolled.
Inclusion Criteria
- Child experienced at least one traumatic event after the age of 36 months
- 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
- At enrollment, the child must be between 4-12 years of age
- The parent/guardian must be willing and able to participate in the treatment and complete informed consent
Exclusion Criteria
- 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
- Parent has had substance use disorder (SUD) within the past 3 months.
- Child or parent is suicidal
- Child or parent is not fluent in English
- 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.
- Child is receiving trauma-focused psychotherapy during study treatment.
- Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home
- Child is having unsupervised face-to-face contact with the identified perpetrator
- Siblings
Data sourced from ClinicalTrials.gov (NCT02537678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.