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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

    Behavioral

    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 Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Total score ranges from 0 to 73, with a higher score indicating worse symptoms.

Time frame
baseline, week 7, week 15
2

Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported

Total score ranges from 0 to 73, with a higher score indicating worse symptoms.

Time frame
baseline, week 7, week 15
3

Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)

Total score ranges from 0 to 65, with a higher score indicating a worse outcome.

Time frame
baseline, week 7, week 15

Secondary outcomes

1

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

A PTSD diagnosis using the DIAMOND-KID Clinical Interview is indicated by answering "yes" to the presence of 4 types of PTSD symptoms.

Time frame
baseline, week 7, week 15
2

Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore

Total score ranges from 0 to 111, with a higher score indicating greater symptom severity.

Time frame
baseline, week 15
3

Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore

Total score ranges from 0 to 30, with a higher score indicating greater symptom severity.

Time frame
baseline, week 15
4

Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale

Total score ranges from 0 (no illness) to 6 (extremely severe), with a higher score indicating a greater severity of trauma symptoms.

Time frame
baseline, week 7, week 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Texas Child Mental Health Care Consortium

Collaborator

Baylor College of Medicine

Collaborator

University of South Florida

Collaborator

University of Houston

Collaborator

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