Stepped Care for Children After Trauma: Optimizing Treatment

NCT ID: NCT02537678

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2020-07-23

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.

Detailed Description

Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to "Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness," and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in "real world" settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed:

Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment);

Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT;

Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment;

Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stepped Care TF-CBT

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

Group Type: EXPERIMENTAL

Stepped Care TF-CBT

Intervention Type: 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

Standard TF-CBT

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

Group Type: ACTIVE_COMPARATOR

Standard TF-CBT

Intervention Type: 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.).

Interventions

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),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

Intervention Type: BEHAVIORAL

Standard TF-CBT

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.).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Child experienced at least one traumatic event after the age of 36 months

2. 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

3. At enrollment, the child must be between 4-12 years of age

4. The parent/guardian must be willing and able to participate in the treatment and complete informed consent

Exclusion Criteria

1. 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

2. Parent has had substance use disorder (SUD) within the past 3 months.

3. Child or parent is suicidal

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. 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.

6. Child is receiving trauma-focused psychotherapy during study treatment.

7. Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home

8. Child is having unsupervised face-to-face contact with the identified perpetrator

9. Siblings

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison A Salloum, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Children's Home Society

Jacksonville, Florida, United States

Directions for Living

Largo, Florida, United States

Pasco Kids First

New Port Richey, Florida, United States

USF St. Petersburg Family Study Center

St. Petersburg, Florida, United States

Suncoast Center, Inc

St. Petersburg, Florida, United States

Crisis Center of Tampa Bay

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25411544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25663796 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23584728 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35032578 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39325087 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed Consent Form Parent

View Document

Document Type: Informed Consent Form: Informed Assent Forms for Children

View Document

Other Identifiers

1R01MH107522-01

Identifier Type: NIH

Identifier Source: org_study_id

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