Stepped Care for Children After Trauma: Optimizing Treatment

NCT02537678 | Completed Results DMC

• 1 other identifier: 1R01MH107522-01
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 6

Brief Summary

Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms

  Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

  Post treatment

• Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms

  Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

  6-month Follow up

• Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms

  Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

  12-month follow up

• Child Sheehan Disability Scale Parent Version

  The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

  Post treatment

• Child Sheehan Disability Scale Parent Version

  The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

  6-month follow up

• Child Sheehan Disability Scale Parent Version

  The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

  12-month follow up

Secondary Outcomes (12)

• Child Behavior Checklist Internalizing Symptoms

  Post treatment

• Child Behavior Checklist Internalizing Symptoms

  6-month follow up

• Child Behavior Checklist Internalizing Symptoms

  12-month follow up

• Child Behavior Checklist Externalizing Symptoms

  Post treatment

• Child Behavior Checklist Externalizing Symptoms

  6-month follow up

Other Outcomes (9)

• Parenting Stress Scale (PSS)

  Post treatment

• Parenting Stress Scale (PSS)

  6-month follow up

• Parenting Stress Scale (PSS)

  12-month follow up

Study Arms (2)

Stepped Care TF-CBT

EXPERIMENTAL

Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT.

Behavioral: Stepped Care TF-CBT

Standard TF-CBT

ACTIVE COMPARATOR

Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT.

Behavioral: Standard TF-CBT

Interventions

Stepped Care TF-CBT BEHAVIORAL

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),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks

Stepped Care TF-CBT

Standard TF-CBT BEHAVIORAL

Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).

Standard TF-CBT

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child experienced at least one traumatic event after the age of 36 months
• Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance
• At enrollment, the child must be between 4-12 years of age
• The parent/guardian must be willing and able to participate in the treatment and complete informed consent

You may not qualify if:

• Psychosis, mental retardation, autism spectrum disorder in the 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 (SUD) within the past 3 months.
• Child or parent is suicidal
• 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. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. 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 during study treatment.
• Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home
• Child is having unsupervised face-to-face contact with the identified perpetrator
• Siblings

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (6)

Children's Home Society

Jacksonville, Florida, 32207, United States

Location

Directions for Living

Largo, Florida, 33773, United States

Location

Pasco Kids First

New Port Richey, Florida, 34654, United States

Location

USF St. Petersburg Family Study Center

St. Petersburg, Florida, 33701, United States

Location

Suncoast Center, Inc

St. Petersburg, Florida, 33733, United States

Location

Crisis Center of Tampa Bay

Tampa, Florida, 33613, United States

Location

Related Publications (5)

• Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108. doi: 10.1016/j.cbpra.2013.07.004.

  PMID: 25411544 BACKGROUND

• Salloum A, Scheeringa MS, Cohen JA, Storch EA. Responder Status Criterion for Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children. Child Youth Care Forum. 2015 Feb;44(1):59-78. doi: 10.1007/s10566-014-9270-1.

  PMID: 25663796 BACKGROUND

• Salloum A, Robst J, Scheeringa MS, Cohen JA, Wang W, Murphy TK, Tolin DF, Storch EA. Step one within stepped care trauma-focused cognitive behavioral therapy for young children: a pilot study. Child Psychiatry Hum Dev. 2014 Feb;45(1):65-77. doi: 10.1007/s10578-013-0378-6.

  PMID: 23584728 RESULT

• Salloum A, Lu Y, Chen H, Quast T, Cohen JA, Scheeringa MS, Salomon K, Storch EA. Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):1010-1022.e4. doi: 10.1016/j.jaac.2021.12.013. Epub 2022 Jan 12.

  PMID: 35032578 RESULT

• Salloum A, Boedeker P, Morris C, Storch EA. Suicidal Ideation, Clinical Worsening and Outcomes among Child Participants in Trauma-Focused Treatment. Res Child Adolesc Psychopathol. 2025 May;53(5):687-700. doi: 10.1007/s10802-024-01242-5. Epub 2024 Sep 26.

  PMID: 39325087 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Alison Salloum
• Organization: University of South Florida

asalloum@usf.edu

8139741535

Study Officials

• Alison A Salloum, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (6)