Stepped Care for Young Children After Trauma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01603563
First received: May 9, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Stepped Care TF-CBT
Behavioral: Standard TF-CBT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepped Care for Young Children After Trauma

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Posttraumatic stress symptoms [ Time Frame: baseline, week 14, and 3 month follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and week 14 and 3 month follow up ] [ Designated as safety issue: No ]
    Change from baseline in the Child Behavior Checklist (Achenbach & Rescorla, 2000) externalizing behaviors at 14 weeks and 3 month follow up

  • Internalizing behaviors [ Time Frame: baseline, week 14 and 3 month follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, week 14 and 3 month follow up ] [ Designated as safety issue: No ]
    Change from baseline in clinical global impression severity (NIMH, 1985)at week 14 and 3 month follow up

  • Global improvement [ Time Frame: baseline, week 14 and 3 month follow up ] [ Designated as safety issue: No ]
    Change from baseline in clinical global impression - improvement (Guy, 1976)at week 14 and 3 month follow up


Estimated Enrollment: 64
Study Start Date: July 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Stepped Care TF-CBT
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.
Active Comparator: 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.).
Behavioral: Standard TF-CBT
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.).

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Parent has had substance use disorder within the past 3 months.
  3. 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.
  4. Child or parent is not fluent in English.
  5. 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.
  6. Child is receiving trauma-focused psychotherapy when study treatment is provided.
  7. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603563

Locations
United States, Florida
Crisis Center of Tampa Bay
Tampa, Florida, United States, 33613-1238
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Alison A Salloum, PhD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01603563     History of Changes
Other Study ID Numbers: 1R34MH092373-01A1
Study First Received: May 9, 2012
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Stepped Care
Trauma-Focused Cognitive Behavioral Therapy
Preschool children

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014