Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (Pilot)

Overview

One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.

Interventions

• Behavioral Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)
  The SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cogniti

Primary outcome measures

• Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index (RI) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (UCLA-RI-5) - Child Reported [Time frame: baseline, week 7, week 15]
• Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported [Time frame: baseline, week 7, week 15]
• Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C) [Time frame: baseline, week 7, week 15]

Secondary outcome measures (9)

• Number of participants with a PTSD Diagnosis as Assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders Child and Adolescent Version (DIAMOND-KID) Clinical Interview [Time frame: baseline, week 7, week 15]
• Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore [Time frame: baseline, week 15]
• Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore [Time frame: baseline, week 15]
• Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale [Time frame: baseline, week 7, week 15]
• Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale [Time frame: baseline, week 7, week 15]
• Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5) [Time frame: baseline, week 15]
• Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) [Time frame: baseline, week 15]
• Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale [Time frame: baseline, week 15]
• Parent Stress as Assessed by the Perceived Stress Scale (PSS) [Time frame: baseline, week 15]

Eligibility criteria

Inclusion criteria

• parent and child agree that the target event/index trauma occurred;
• report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);
• suicidal ideation does not exclude as long as there is no active plan/intent. Safety planning implemented and continued assessment for plan/intent;
• children ages 7-12 and a legal guardian willing to participate;
• can be fluent in English or Spanish;
• at least 4 weeks since child's exposure to one or more potentially traumatic events;
• trauma exposure occurred after child was 36 months old.

Exclusion criteria

• Children with pervasive developmental disorders or Autism;
• legal guardian or child with active psychosis;
• any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;
• children who have unsupervised visitation with their perpetrator;
• perpetrator (person that harmed child) is living in the home;
• active substance use disorder;
• child is currently receiving trauma-focused therapy;
• legal guardian is actively suicidal will be excluded from participation;
• children who have not been stable on psychotropic medication for 4 or more weeks, and/or for benzodiazepines/stimulants not stable for 2 or more weeks will not be eligible for the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07396935 · HSC-MS-25-0929 (Pilot)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗