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Stepped Care for Young Children After Trauma

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stepped Care TF-CBT

Standard TF-CBT

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Stepped Care, Trauma-Focused Cognitive Behavioral Therapy, Preschool children

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Child must have experienced at least one traumatic event after the age of 36 months.
At least five Postttraumatic stress symptoms with one symptom of reexperiencing or one symptom of avoidance.
Child must be between 3 and 7 years of age at the time of enrollment.
The parent must be willing and able to participate in the treatment and complete informed consent.

Exclusion Criteria:

Psychosis, mental retardation, autism, or related pervasive developmental disorders in 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 within the past 3 months.
Child or parent is suicidal (the DIPA will be used to screen for child suicidal ideation and the SCID-RV will be used to screen for parent suicide ideation; assessed by all available information). A delayed entry once the parent or child is stabilized (at least 6 months post suicidal) and not having suicidal ideation will be allowed.
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. 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 when study treatment is provided.
Parent or caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home (e.g. mother's boyfriend, sibling).

Sites / Locations

Crisis Center of Tampa Bay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped Care TF-CBT

Standard TF-CBT

Arm Description

Patients will receive step one: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the National Child Traumatic Stress Network website (via web or paper for those without access). Children who do not meet responder status will receive step two: 9 (1 to 1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks.

Patients will receive 12 (1 to 1.5 hr.) standard weekly in-office therapist-directed sessions over 12 to 14 weeks (Phase II only). The 2 additional weeks allow for scheduling difficulty. Standard TF-CBT includes child, parent and conjoint parent-child sessions addressing the core trauma treatment components discussed in section a.3 (e.g. stress management, skill building, gradual exposure, & trauma narrative etc.).

Outcomes

Primary Outcome Measures

Posttraumatic stress symptoms

Change from baseline in Diagnostic Preschool Infant Assessment PTSD module (DIPA; Scheeringa, 2010) and in the Trauma Symptom Checklist for Young Children (Briere et al., 2001) at 14 weeks and 3 month follow up

Secondary Outcome Measures

Externalizing behaviors

Change from baseline in the Child Behavior Checklist (Achenbach & Rescorla, 2000) externalizing behaviors at 14 weeks and 3 month follow up

Internalizing behaviors

Change from baseline in the Child Behavior Checklist (Achenbach & Rescorla, 2000) internalizing behaviors at week 14 and 3 month follow up

Independent Evaluator-rated PTSD symptom and impairment severity

Change from baseline in clinical global impression severity (NIMH, 1985)at week 14 and 3 month follow up

Global improvement

Change from baseline in clinical global impression - improvement (Guy, 1976)at week 14 and 3 month follow up

Full Information

NCT ID

NCT01603563

First Posted

May 9, 2012

Last Updated

April 23, 2015

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT01603563

Brief Title

Stepped Care for Young Children After Trauma

Official Title

Stepped Care for Young Children After Trauma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of South Florida

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures, treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the effectiveness of SC-TF-CBT for early childhood PTSD.

Detailed Description

Young children who are exposed to traumatic events such as abuse, disasters, accidents, illnesses, injury and the death of a person close to them are at risk for developing PTSD. While effective treatments for childhood PTSD exist, novel interventions that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The purpose of this study is to develop and test the feasibility of an intervention called Stepped Care Trauma-Focused Cognitive Behavioral Therapy which has the potential to greatly improve service delivery approaches to make treatment more accessible and less costly, thereby reducing childhood PTSD and related societal impacts and costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

Stepped Care, Trauma-Focused Cognitive Behavioral Therapy, Preschool children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stepped Care TF-CBT

Arm Type

Experimental

Arm Description

Arm Title

Standard TF-CBT

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Stepped Care TF-CBT

Intervention Description

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), scheduled weekly phone meetings (15 minutes), and information from the National Child Traumatic Stress Network website (via web or paper for those without access). Children who do not meet responder status will receive step two: 9 (1 to 1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Standard TF-CBT

Intervention Description

Standard TF-CBT patients will receive 12 (1 to 1.5 hr.) standard weekly in-office therapist-directed sessions over 12 to 14 weeks (Phase II only). The 2 additional weeks allow for scheduling difficulty. Standard TF-CBT includes child, parent and conjoint parent-child sessions addressing the core trauma treatment components discussed in section a.3 (e.g. stress management, skill building, gradual exposure, & trauma narrative etc.).

Primary Outcome Measure Information:

Title

Posttraumatic stress symptoms

Description

Time Frame

baseline, week 14, and 3 month follow up

Secondary Outcome Measure Information:

Title

Externalizing behaviors

Description

Change from baseline in the Child Behavior Checklist (Achenbach & Rescorla, 2000) externalizing behaviors at 14 weeks and 3 month follow up

Time Frame

baseline and week 14 and 3 month follow up

Title

Internalizing behaviors

Description

Change from baseline in the Child Behavior Checklist (Achenbach & Rescorla, 2000) internalizing behaviors at week 14 and 3 month follow up

Time Frame

baseline, week 14 and 3 month follow up

Title

Independent Evaluator-rated PTSD symptom and impairment severity

Description

Change from baseline in clinical global impression severity (NIMH, 1985)at week 14 and 3 month follow up

Time Frame

baseline, week 14 and 3 month follow up

Title

Global improvement

Description

Change from baseline in clinical global impression - improvement (Guy, 1976)at week 14 and 3 month follow up

Time Frame

baseline, week 14 and 3 month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Child must have experienced at least one traumatic event after the age of 36 months. At least five Postttraumatic stress symptoms with one symptom of reexperiencing or one symptom of avoidance. Child must be between 3 and 7 years of age at the time of enrollment. The parent must be willing and able to participate in the treatment and complete informed consent. Exclusion Criteria: Psychosis, mental retardation, autism, or related pervasive developmental disorders in 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 within the past 3 months. Child or parent is suicidal (the DIPA will be used to screen for child suicidal ideation and the SCID-RV will be used to screen for parent suicide ideation; assessed by all available information). A delayed entry once the parent or child is stabilized (at least 6 months post suicidal) and not having suicidal ideation will be allowed. 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. 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 when study treatment is provided. Parent or caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home (e.g. mother's boyfriend, sibling).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison A Salloum, PhD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Crisis Center of Tampa Bay

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1238

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26443493

Citation

Salloum A, Wang W, Robst J, Murphy TK, Scheeringa MS, Cohen JA, Storch EA. Stepped care versus standard trauma-focused cognitive behavioral therapy for young children. J Child Psychol Psychiatry. 2016 May;57(5):614-22. doi: 10.1111/jcpp.12471. Epub 2015 Oct 7.

Results Reference

derived

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Stepped Care for Young Children After Trauma

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