NCT01603563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

3.1 years

First QC Date

May 9, 2012

Last Update Submit

April 23, 2015

Conditions

Posttraumatic Stress Disorder

Keywords

Stepped CareTrauma-Focused Cognitive Behavioral TherapyPreschool children

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline, week 14, and 3 month follow up

Secondary Outcomes (4)

  • Externalizing behaviors

    baseline and week 14 and 3 month follow up

  • Internalizing behaviors

    baseline, week 14 and 3 month follow up

  • Independent Evaluator-rated PTSD symptom and impairment severity

    baseline, week 14 and 3 month follow up

  • Global improvement

    baseline, week 14 and 3 month follow up

Study Arms (2)

Stepped Care TF-CBT

EXPERIMENTAL

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.

Behavioral: Stepped Care TF-CBT

Standard TF-CBT

ACTIVE COMPARATOR

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.).

Behavioral: Standard TF-CBT

Interventions

Stepped Care TF-CBTBEHAVIORAL

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.

Stepped Care TF-CBT
Standard TF-CBTBEHAVIORAL

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.).

Standard TF-CBT

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crisis Center of Tampa Bay

Tampa, Florida, 33613-1238, United States

Location

Related Publications (1)

  • 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.

    PMID: 26443493DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Alison A Salloum, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 23, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

US(1)